4-tert-butylbenzoic acid

Eye irritation

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

Guideline:

other: 84/449/EEC appendix V B5

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylbenzoic acid

EC Number:

202-696-3

EC Name:

4-tert-butylbenzoic acid

Cas Number:

98-73-7

Molecular formula:

C11H14O2

IUPAC Name:

4-tert-butylbenzoic acid

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.