Registration Dossier
Registration Dossier
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EC number: 204-185-0 | CAS number: 117-34-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Authoritive database
Data source
Referenceopen allclose all
- Reference Type:
- other: Authoritive database
- Title:
- Skin irritation for CAS NO: 98-73-7
- Author:
- IFA (GESTIS)
- Year:
- 2 017
- Bibliographic source:
- GESTIS SUBSTANCE Database (information system in hazardous substance of the Berufsgenossenscheftn)
- Reference Type:
- review article or handbook
- Title:
- European Union Risk Assessment Report 4-TERT-BUTYLBENZOIC ACID
- Author:
- European Union Risk Assessment Report-RAPPORTEUR [GERMANY]
- Year:
- 2 009
- Bibliographic source:
- European Union Risk Assessment Report-RAPPORTEUR [GERMANY]- July 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Skin irritation study was conducted on 6 New Zealand albino rabbits to assess the irritation potential of 4-tert-Butylbenzoic acid
- GLP compliance:
- not specified
Test material
- 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 (PTBBA)
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:4-Tert-Butylbenzoicacid
Molecular formula: C11H14O2
Molecualr Weight:178.23 g/mol
Substance Type: Organic
Physical State: Solid
InChI: 1S/C11H14O2/c1-11(2,3)9-6-4-8(5-7-9)10(12)13/h4-7H,1-3H3,(H,12,13)
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical:4-Tert-Butylbenzoicacid
Molecular formula: C11H14O2
Molecualr Weight:178.23 g/mol
Substance Type: Organic
Physical State: Solid
InChI: 1S/C11H14O2/c1-11(2,3)9-6-4-8(5-7-9)10(12)13/h4-7H,1-3H3,(H,12,13)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No Data Available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- No Data Available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hours after the removal of the dressing.
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No known signs of skin irritation were observed
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- No cutaneous reaction was detected. Hence, 4-Tert-butylbenzoic acid was considered to be not irritating to the rabbit’s skin.
- Executive summary:
Skin irritation study was performed in 6 New Zealand albino rabbits in accordance with EU test guideline B4 to assess the irritation potential of 4-Tert-butylbenzoic acid.
Single application of 500 mg of 4-tert-butylbenzoic acid moistened with water was applied to a clipped area of 6 New Zealand albino rabbits and was held in contact with the skin for 4 hours by a semi-occlusive dressing. The skin reactions were read at1, 24, 48, and 72 hours after the removal of the dressing.
No cutaneous reaction was detected. Hence, 4-Tert-butylbenzoic acid was considered to be not irritating to the rabbit’s skin.
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