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Administrative data

Description of key information

skin irritation, supporting study: Draize skin irritation test, albino rabbits, one male and one female, occlusive patches, 800 mg/kg bw (solid PTBBA) and 300 mg/kg bw (alcohol-mineral oil suspension). No signs of skin irritation were observed. Neither preparation caused systemic or skin changes. 
skin irritation, key study: according to E.E.C. Directive 84/449/EEC appendix V B4, New Zealand albino rabbits, 6 males, semi-occlusive, 500 mg PTBBA on a moistened Codex hydrophilic gauze patch aplied to skin: Summary of results: No cutaneous reaction was observed one hour, 24, 48 and 72 hours after the removal of the dressing. The scoring was at all times "0" concerning erythema and eschar formation as well as oedema formation.
eye irritation: according to 84/449/EEC appendix V B5, New Zealand albino rabbits, 6 males, single introduction of 100 mg (left eye):
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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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 the study was performed in accordance with GLP guidelines but no provision of a certificate; info about the vehicle/application of the substance lacks some information details. The study was performed in accordance with an official guideline. The methodology, evaluation of the results and the results themselves are well documented.
Qualifier:
according to guideline
Guideline:
other: E.E.C. Directive 84/449/EEC appendix V B4
GLP compliance:
yes
Species:
rabbit
Strain:
other: "New-Zealand albino rabbits"
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles-en-Mauges, France)
- Sex: all males
- weight on day of treatment: 2.5 +/- 0.1 kg
- identification of individuals by ear-tags
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Controls:
other: on each animal was a control site and a test site
Duration of treatment / exposure:
4 h
Observation period:
up to 72 h
Number of animals:
6

Summary of results:

No cutaneous reaction was observed one hour, 24, 48 and 72 hours after the removal of the dressing. The scoring was at all times "0" concerning erythema and eschar formation as well as oedema formation.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
According to the results of the study the test substance showed no cutaneous reactions (after 1, 24, 48 and 72 hours) on the rabbits skin and can therefore be considered as not irritating to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC appendix V B5
GLP compliance:
yes
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
Observation period (in vivo):
1, 24, 48 and 72 hours after introduction of the test substance
Number of animals or in vitro replicates:
6

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.

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The available data about skin irritation/corrosion and eye irritation suggest that 4 -tertbutyl benzoic acid is not irritating. There is no data available about respiratory irritation.


Justification for selection of skin irritation / corrosion endpoint:
Summary of data cited in reliable reference (European Union Risk Assessment Report - 4-TERT-BUTYLBENZOIC ACID- RISK ASSESSMENT
July 2009, FINAL APPROVED VERSION)

Justification for selection of eye irritation endpoint:
Summary of data cited in reliable reference (European Union Risk Assessment Report - 4-TERT-BUTYLBENZOIC ACID- RISK ASSESSMENT
July 2009, FINAL APPROVED VERSION)

Justification for classification or non-classification

Based on the available data on skin and eye irritation no corresponding signs of irritation were observed.

Reason for no classification: conclusive, but not sufficient for classification.