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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
A dose of 50 mg Chohedur RK (= m-phenylene di(acetate)) was administered into one eye of two young adult New Zealand white rabbits (3–4 kg). The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
All effects were fully reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the Draize scores for cornea opacity and conjunctivae a classification as eye irritant is adequate.
Executive summary:

A dose of 50 mg Chohedur RK (= m-phenylene di(acetate)) was administered into one eye of two young adult New Zealand white rabbits (3–4 kg). The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize. The cornea score was 2.66, the iris score was 0.83 and the conjunctivae and chemosis score were 2.33 and 1.33, respectively. All effects were reversible within 7 days. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Eye Irrit. 2 ( H319: Causes serious eye irritation.) is justified.