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

Eye irritation

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

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 / 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.