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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:
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

Constituent 1
Chemical structure
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.

 

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