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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from data from review article or handbbok

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of DMDM Hydantoin
Author:
Cosmetic Ingredient Review
Year:
1988
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 7, Number 3, 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: According to the protocol outlined in Title 16 parts 1500.3 (c)(4) and 1500.41 of the Code of Federal Regulations.
Principles of method if other than guideline:
The primary irritation potential of test chemical 1,3-Dimethylol-5,5-dimethylhydantoin (CAS No: 6440-58-0) was assessed in albino rabbits according to the protocol outlined in Title 16 parts 1500.3 (c)(4) and 1500.41 of the Code of Federal Regulations.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 1,3-Dimethylol-5,5-dimethylhydantoin
- Molecular formula: C7H12N204
- Molecular weight: 188.1818 g/mol
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1,3-Dimethylol-5,5-dimethylhydantoin
- Molecular formula: C7H12N2O4
- Molecular weight: 188.1818 g/mol
- Substance type: organic
- Physical state: Solid
- Smiles notation: CC1(C(=O)N(C(=O)N1CO)CO)C
- InChl: 1S/C7H12N2O4/c1-7(2)5(12)8(3-10)6(13)9(7)4-11/h10-11H,3-4H2,1-2H3

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals and environmental conditions:
No Data Available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact clipped skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Amount:0.5mL
concentration applied:0.1%
Duration of treatment / exposure:
24 hours

Observation period:
48 hours
Number of animals:
6
Details on study design:
- Type of wrap if used: square patch made of surgical gauze

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No known signs of skin irritation were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material 1,3-Dimethylol-5,5-dimethylhydantoin (CAS No: 6440-58-0) was considered to be not irritating to both abraded and intact clipped skin of albino rabbits.
Executive summary:

The primary irritation potential of test chemical 1,3-Dimethylol-5,5-dimethylhydantoin (CAS No: 6440-58-0) was assessed according to the protocol outlined in Title 16 parts 1500.3 (c)(4) and 1500.41 of the Code of Federal Regulations.

 

According to this protocol, 1,3-Dimethylol-5,5-dimethylhydantoin(volume, 0.5 ml) was applied to both abraded and intact clipped skin of albino rabbits (a minimum of 6) via a square patch made of surgical gauze (Table 6). The patches remained intact for 24 h, after which any reactions were evaluated. Subsequent evaluations were made 48 h after the initial ones. .

 

No known signs of irritation were observed after skin evaluation. Hence1,3-Dimethylol-5,5-dimethylhydantoin (CAS No: 6440-58-0)was considered to be not irritating to both abraded and intact clipped skin of albino rabbits.