4-ethyl-2,3-dioxopiperazine-1-carbonyl chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment reports

Data source

Reference

Reference Type:

review article or handbook

Title:

IUCLID Dataset

Author:

BASF AG

Year:

1992

Bibliographic source:

IUCLID Dataset- BASF AG- 08-DEC-1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Skin irritation study of Theophylline was conducted on White Vienna rabbits under semi-occlusion to observe its irritation efficacy.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Theophylline

EC Number:

200-385-7

EC Name:

Theophylline

Cas Number:

58-55-9

Molecular formula:

C7H8N4O2

IUPAC Name:

1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Theophylline
- Molecular formula: C7H8N4O2
- Molecular weight: 180.166 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): Theophylline
- Molecular formula: C7H8N4O2
- Molecular weight: 180.166 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

Amount: 500mg
concentration applied: 50% aqueous suspension

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (1 male and 2 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application sites were washed.
- Time after start of exposure: 4 hours

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight reddening was observed in the 2 females at 4 hours. No other signs of irritation were noted.

Other effects:

no other effects were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The test material Theophylline (CAS No:- 58-55-9)was observed to be non irritant to the skin of White Vienna rabbits as the mean irritation index was 0.0.

Executive summary:

Skin irritation study was performed in 3 White Vienna rabbits (1 male and 2 female) for the test chemical Theophylline(CAS No:-58-55-9) in accordance with OECD Guide-line 404 "Acute Dermal Irritation/Corrosion".

In this test, the rabbits were exposed to 500mg of 50% test chemical for 4 hours exposure period under semi-occlusive condition.

 

After 4 h, the application patches were removed, and the application sites were washed. Scoring was made at 4, 24, 48, and 72 hours after beginning of the study. Very slight reddening was observed in the 2 females at 4 hours. No other signs of irritation were noted.

 

 As the mean irritation index was 0.0, the test chemical Theophylline(CAS No:-58-55-9) was considered to be not irritating to the skin of White Vienna rabbits.