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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:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to OECD TG 405 and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Adipic acid
EC Number:
204-673-3
EC Name:
Adipic acid
Cas Number:
124-04-9
Molecular formula:
C6H10O4
IUPAC Name:
adipic acid
Details on test material:
Test substance purity >99.8%

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Concentration: 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24 h, 7 and 14 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 16 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 9 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 9 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks:
nictating membrane swollen until day7
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks:
nictating membrane swollen until day 9
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 days

Any other information on results incl. tables

Under the present test conditions, a single application of 100 mg acipid acid 

per animal into the conjunctival sac of the right eye of  three rabbits caused 

the following changes:
Corneal opacity was observed in all animals: 
- animal no. 1: 1 hour to 72 hours (grade 3), 4 to 6 days (grade 2) and 7  to 15 days (grade 1) after instillation;
- animal no. 2: 1 hour to 72 hours (grade 2) and 4 to 12 days (grade 1)  after instillation;
- animal no. 3: 1 hour (grade 3), 24 to 72 hours (grade 2) and 4 to 12  days (grade 1) after instillation.

The fluorescein test performed 24 hours after instillation revealed  comeal

staining in animal nos. 1 and 3 (3/4 of the surface) and animal  no. 2 (1/2 of

the surface). The fluorescein test performed 7 days after  instiltation

revealed corneal staining in animal nos. 1 and 3 (1/2 of the  surface) and

animal no. 2 (1/4 of the surface). The fluorescein test  performed 14 days

after instillation revealed corneal staining in animal  no. 1 (1/4 of the

surface).

Irritation of the iris was observed in all animals:
- animal no. 1: 1 hour to 4 days (grade 2) and 5 to 8 days (grade 1)

after instillation;
- animal no. 2: 1 hour and 24 hours (grade 2) and 48 hours to 6 days

(grade 1) after instillation;
- animal no. 3: 1 hour to 72 hours (grade 2) and 4 to 8 days (grade 1)

after instillation.

Conjunctival redness (grade 1) was observed in animal no. one 1 hour to

12 days, in animal nos. two and three 1 hour to 72 hours after  instillation.

Conjunctival chemosis (grade 1) was observed in animal nos. one and two 1  hour

to 6 days, in animal no. three 1 hour to 11 days after instillation. 

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
highly irritating, risk of serious damage to eyes
Executive summary:

Severe eye irritation was observed in a study performed according to OECD TG 405, conducted in compliance with GLP after the application of 100 mg adipic acid. Corneal opacity and irritation of the iris was observed in all animals up to grade 3 and grade 2, respectively. The observed effects were reversible within 16 days (LPT 2004)