Thiazolidine-2,4-dione

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione

Cas Number:

6440-58-0

Molecular formula:

C7H12N204

IUPAC Name:

1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione

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 or test system 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.