Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
other: see 'Remark'
Remarks:
Although info about the batch of the tested substance is delivered, no info about its purity is given; statement that study was performed in accordance with GLP guidelines but no provision of a certificate. The study was performed in accordance with an official guideline. The methodology, evaluation of the results and the results themselves are well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EEC appendix V B5
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ACIDE P-TERTIOBUTYLBENZOIQUE, Acide p.tertiobutylbenzoique (acide P.T.B.B.) lot 8802217
- supplier: Société Francaise Hoechst, Tour Roussel Hoechst, Cédex 03, 92080 Paris La Défense, France.

Test animals / tissue source

Species:
rabbit
Strain:
other: "New Zealand albino rabbits"
Details on test animals or tissues and environmental conditions:
Supplier of animals: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
Sex of animals: all male

Test system

Observation period (in vivo):
1, 24, 48 and 72 hours after introduction of the test substance
Number of animals or in vitro replicates:
6

Results and discussion

Any other information on results incl. tables

Summary of results:

One hour after the introduction of the test substance, moderate conjunctival reactions and slight discharge were observed in all the animals. After 24 hours, the conjunctival reactions regressed and were slight in all the animals and minimal corneal opacity was noted in 2 animals. After 48 hours, only slight conjunctival lesions persisted in one animal. After 72 hours, no ocular reaction was noted.

Results:

One hour after introduction of the test substance, the following conjunctival reactions were observed:

- swelling more than normal in one animal

- obvious swelling with partial eversion of the eyelids in 5 animals

- definite hyperaemia of certain blood vessels in 2 animals

- diffuse crimson colouration of the blood vessels in 4 animals

- slight discharge in all the animals.

After 24 h, the conjunctival lesions regressed, the discharge was no longer noted and minimal corneal opacity appeared in 2 animals.

After 48 h, only swelling more than normal of the conjunctiva and definite hyperaemia of certain blood vessels were still noted in one animal.

After 72 h, the ocular reactions were no longer noted.

Table with summary of the results

Mean score per area Observation time
1 hour 24 hours 48 hours 72 hours
Chemosis 1.8 0.8 0.2 0
Redness of the conjunctiva 1.7 1.2 0.2 0
Iris 0 0 0 0
Corneal opacity 0 0.3 0 0

Conclusion in the study report:

Under the experimental conditions of the present study, the test substance ACIDE P-TERTIOBUTYLBENZOIQUE is considered non-irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: statement in the study report
Conclusions:
According to the result of the study the test substance is considered as non-irritant to the rabbits eye since the ocular reactions noted 1, 24 and 48 hours after the introduction were completely reversible after 72 hours.