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IMIDAZOLIDINYL UREA

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Imidazolidinyl urea is an antimicrobial preservative used in cosmetics. Products containing this preservative are often labeled "hypoallergenic".

Specific Substances

    1) Germall 115(R)
    2) Methanebis
    3) N,N'-(5-ureido-2,4-diketotetrahydroimidazole)-N,N-dimethylol
    4) N,N'methylenebis(N'-(1-hydroxymethyl)-2,5-dioxo-4-imidazolidinyl)urea
    5) Urea, N,N''-methylenebis(N'-(1-(hydroxymethyl)- 2,5-dioxo-4-imidazolidinyl)-
    6) CAS 39236-46-9

Available Forms Sources

    A) SOURCES
    1) TRADE NAMES: Germall 115(R) (Sutton Laboratories), Piasolan(R).
    B) USES
    1) Imidazolidinyl urea is the most commonly used cosmetic preservative excluding the parabens. It has synergistic antimicrobial activity when combined with other preservatives, and is frequently used in combination with parabens (Fisher, 1980). Concentrations ranging from 0.02 to 0.5% are used in cosmetics (Ziegler et al, 1988).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) Limited data exist on the effects of acute toxicity; no human cases could be documented. Gastrointestinal irritation is the primary effect noted in animals, consisting of diarrhea, GI ulceration, and bleeding. Sensitization and allergic contact dermatitis are rare. Cross-sensitization to formaldehyde has occasionally been documented.
    0.2.8) GASTROINTESTINAL
    A) Gastrointestinal ulceration and bleeding were observed in rats given 11.3 g/kg and in mice given 7.2 g/kg orally.
    0.2.14) DERMATOLOGIC
    A) Cosmetic dermatitis can be attributed to imidazolidinyl urea in about 3% of patients tested in the United States.

Laboratory Monitoring

    A) Patch testing with 2% in petrolatum and 2% in water is recommended in patients with suspected contact hypersensitivity.

Treatment Overview

    0.4.5) DERMAL EXPOSURE
    A) OVERVIEW
    1) DECONTAMINATION: Remove contaminated clothing and jewelry and place them in plastic bags. Wash exposed areas with soap and water for 10 to 15 minutes with gentle sponging to avoid skin breakdown. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).

Range Of Toxicity

    A) Ingestion of cosmetics preserved with imidazolidinyl urea are unlikely to produce acute toxicity due to low concentrations.

Clinical Effects

Summary Of Exposure

    A) Limited data exist on the effects of acute toxicity; no human cases could be documented. Gastrointestinal irritation is the primary effect noted in animals, consisting of diarrhea, GI ulceration, and bleeding. Sensitization and allergic contact dermatitis are rare. Cross-sensitization to formaldehyde has occasionally been documented.

Gastrointestinal

    3.8.1) SUMMARY
    A) Gastrointestinal ulceration and bleeding were observed in rats given 11.3 g/kg and in mice given 7.2 g/kg orally.
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) GASTRIC ULCER HEMORRHAGIC
    a) Acute toxic effects observed in rodents given lethal doses included gastric ulceration and bleeding, hypermotility, and diarrhea (RTECS , 2000).

Dermatologic

    3.14.1) SUMMARY
    A) Cosmetic dermatitis can be attributed to imidazolidinyl urea in about 3% of patients tested in the United States.
    3.14.2) CLINICAL EFFECTS
    A) CONTACT DERMATITIS
    1) INCIDENCE -
    a) DERMATITIS PATIENTS - Patch testing of heterogeneous populations of contact dermatitis patients demonstrates positive reactions to imidazolidinyl urea in 0.5 to 0.9% of patients seen at dermatology clinics (Dooms-Goossens et al, 1986; Ford & Beck, 1986).
    b) COSMETIC DERMATITIS PATIENTS - In a selected group of patients with cosmetic-related dermatitis, a higher prevalence of confirmed sensitivity to imidazolidinyl urea was found, with 21 of 713 (2.9%) attributed to this preservative (Adams & Maibach, 1985).
    2) All reported reactions have occurred from use of leave-on cosmetic products, such as face creams. The eyelids were the only site involved in one patient who applied the cream to the entire face (de Groot & Weyland, 1987).
    3) FORMALDEHYDE CROSS-REACTIONS - Because imidazolidinyl urea is a weak formaldehyde releaser, it is suspected that cross-sensitivity may occur in formaldehyde-sensitive individuals.
    a) Positive patch tests to formaldehyde have been confirmed in a few patients with imidazolidinyl urea-induced contact dermatitis (de Groot & Weyland, 1987), but have been negative in others (Foussereau & Cavelier, 1989; van Neer & van der Kley, 1991; Ando et al, 2000).
    b) INCIDENCE - Formaldehyde sensitivity was documented in 1 of 8 patients reacting to imidazolidinyl urea in one series (Dooms-Goossens et al, 1986).
    1) In one study to determine the correlation between agents in a patch testing standard series, a highly statistically significant association occurred between formaldehyde and imidazolidinyl urea (Albert et al, 1999).
    4) OTHER CROSS-REACTIONS - The related analog, diazolidinyl urea (Germal II)(R), has produced dermatitis in patients sensitive to imidazolidinyl urea (Dooms-Goossens et al, 1986). The former compound is a more potent sensitizer. In a volunteer study, 50% of patients sensitized to diazolidinyl urea also reacted to imidazolidinyl urea (Jordan, 1984).
    5) CASE REPORT - An adult female developed allergic contact dermatitis after use of an ultrasonic gel which contained imidazolidinyl urea (Ando et al, 2000). Symptoms improved after 7-10 days of topical therapy.
    3.14.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) IRRITATION
    a) Imidazolidinyl urea was NOT irritating when applied to shaved guinea pigs in concentrations of up to 50% (Ziegler et al, 1988).
    2) ALLERGIC REACTION
    a) The potential for repeated application of imidazolidinyl urea to induce sensitization was evaluated in 50 guinea pigs given weekly applications of various concentrations of aqueous solutions. Contact hypersensitivity was not induced with concentrations of 0.3 and 1%, but could be induced in 1 of 8 animals with 5, 25, or 50% solutions. Two of three sensitized animals subsequently reacted with formaldehyde (Ziegler et al, 1988).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS39236-46-9 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Patch testing with 2% in petrolatum and 2% in water is recommended in patients with suspected contact hypersensitivity.

Methods

    A) OTHER
    1) The commercially available patch test material contains 2% in petrolatum. Two patients with cosmetic dermatitis exhibited negative patch tests to the 2% in petrolatum product and tested positive to a 0.3% aqueous solution (Foussereau & Cavelier, 1989). Another patient tested negative to 2% in petrolatum and positive to 2% aqueous (van Neer & van der Kley, 1991). Testing with both vehicles is suggested, to avoid false negative reactions (Foussereau & Cavelier, 1989).
    2) ROAT - Repeated open application tests (ROAT) may be necessary to establish the diagnosis of imidazolidinyl urea sensitivity in patients with negative patch testing results (de Groot & Weyland, 1987).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Monitoring

    A) Patch testing with 2% in petrolatum and 2% in water is recommended in patients with suspected contact hypersensitivity.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) SUMMARY -
    1) Ingestion of cosmetics preserved with imidazolidinyl urea is unlikely to produce acute toxicity due to low concentrations. The decision to perform gastric decontamination should be based on other product ingredients.
    6.5.2) PREVENTION OF ABSORPTION
    A) SUMMARY
    1) Ingestion of cosmetics preserved with imidazolidinyl urea is unlikely to produce acute toxicity due to low concentrations. The decision to perform gastric decontamination should be based on other product ingredients.
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment is symptomatic and supportive; acute ingestion is unlikely to require medical care.

Dermal Exposure

    6.9.1) DECONTAMINATION
    A) DECONTAMINATION: Remove contaminated clothing and wash exposed area thoroughly with soap and water for 10 to 15 minutes. A physician may need to examine the area if irritation or pain persists (Burgess et al, 1999).
    6.9.2) TREATMENT
    A) ACUTE ALLERGIC REACTION
    1) Most patients with formaldehyde sensitivity can tolerate cosmetics preserved with imidazolidinyl urea. These products should not be applied to abraded areas, areas of active dermatitis, or sensitive areas such as eyelids.
    B) DERMATITIS
    1) Patients developing dermal hypersensitivity reactions may require treatment with systemic or topical corticosteroids or antihistamines.
    C) Treatment should include recommendations listed in the ORAL EXPOSURE section when appropriate.

Range Of Toxicity

Summary

    A) Ingestion of cosmetics preserved with imidazolidinyl urea are unlikely to produce acute toxicity due to low concentrations.

Workplace Standards

    A) ACGIH TLV Values for CAS39236-46-9 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS39236-46-9 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS39236-46-9 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS39236-46-9 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (ORAL)RAT:
    1) 11,300 mg/kg ((RTECS, 2000))
    B) LD50- (ORAL)MOUSE:
    1) 7200 mg/kg ((RTECS, 2000))

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Imidazolidinyl urea exhibits good antimicrobial activity against gram-positive and gram-negative bacteria, and has activity for some yeast and molds (Fisher, 1980).

Toxicologic Mechanism

    A) High concentrations of imidazolidinyl urea can potentially release free formaldehyde. At the usual preservative concentration of 0.1%, little formaldehyde is produced. At concentrations of 2%, 39 to 90 ppm of formaldehyde were produced; these levels did not cause positive patch tests in formaldehyde-sensitive subjects (Fisher, 1980).
    B) Since the threshold concentration for elicitation of dermatitis in a formaldehyde-sensitive individual can be as low as 30 ppm, it is likely that some extremely sensitive patients would react to imidazolidinyl urea (Jordan et al, 1979).

Physicochemical

Physical Characteristics

    A) Imidazolidinyl urea is colorless, odorless, and tasteless.

Molecular Weight

    A) 388.35 (RTECS , 2000)

References

General Bibliography

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