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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 review article or handbook

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 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
An eye irritation study of Theophylline was conducted on White Vienna rabbits in accordance with OECD Guide-line 405 to observe its effects on rabbits’ eye.
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 / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
not specified
Amount / concentration applied:
1mL
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1, 24, 48, and 72 hours and at 8 days after instillation
Number of animals or in vitro replicates:
3 (male)
Details on study design:
TEST SITE
- Area of exposure: The test substance was placed into the right conjunctival sac of each of 3 male White Vienna rabbits

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 8 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).
Other effects:
Very slight corneal opacity was observed in 1-2 rabbits up to day 8. Slight to well-defined conjunctival redness and conjunctival swellings were observed in all 3 rabbits up to 72h and 48h, respectively. On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time. The findings were reversible in 2 of the 3 animals
Since, the findings were reversible in 2 of the 3 animals, therefore Theophylline (CAS No:-58-55-9) was considered to be not irritating to the eyes of White Vienna rabbits.
Executive summary:

An eye irritation study was performed in 3 White Vienna rabbits male for the test chemical Theophylline(CAS No:-58-55-9) in accordance with OECD Guide-line 405 "Acute Eye Irritation/Corrosion".

The test substance was placed into the right conjunctival sac of each of 3 male White Vienna rabbits.The eyes were not rinsed. Scoring was made at 1, 24, 48, and 72 hours and at 8 days after instillation.Very slight corneal opacity was observed in 1-2 rabbits up to day 8. Slight to well-defined conjunctival redness and conjunctival swellings were observed in all 3 rabbits up to 72h and 48h, respectively. Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time. The findings were reversible in 2 of the 3 animals

Mean irritation indices were 0.6 (corneal opacity), 0.0 (iritis), 1.8 (conjunctival redness), and 0.6 (conjunctival swelling).On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time. The findings were reversible in 2 of the 3 animals

Since, the findings were reversible in 2 of the 3 animals, therefore Theophylline (CAS No:-58-55-9) was considered to be not irritating to the eyes of White Vienna rabbits.

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