3-phenylpropionic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

secondary source

Title:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP OPINION ON Benzoic Acid and Sodium Benzoate

Author:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP

Year:

2005

Bibliographic source:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS - SCCP OPINION ON Benzoic Acid and Sodium Benzoate, Adopted by the SCCP during the 4th plenary of 21 June 2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To assess the dermal irritation potential of Benzoic acid according to OECD 404 Guidelines

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid

EC Number:

200-618-2

EC Name:

Benzoic acid

Cas Number:

65-85-0

Molecular formula:

C7H6O2

IUPAC Name:

Benzoic Acid

Test material form:

solid

Details on test material:

Details on test material
- Name of test material : Benzoic acid
- Molecular formula : C7 H6 O2
- Molecular weight : 122.1224 g/mol
- Smiles notation : c1(ccccc1)C(=O)O
- InChl : 1S/C7H6O2/c8-7(9)6-4-2-1-3-5-6/h1-5H,(H,8,9)
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material : Benzoic acid
- Molecular formula : C7 H6 O2
- Molecular weight : 122.1224 g/mol
- Smiles notation : c1(ccccc1)C(=O)O
- InChl : 1S/C7H6O2/c8-7(9)6-4-2-1-3-5-6/h1-5H,(H,8,9)
- Substance type: Organic
- Physical state: Solid
Purity: 99.5%

Test animals

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or test system and environmental conditions:

sex: Female

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact

Vehicle:

other: Milli-RO water

Controls:

yes

Amount / concentration applied:

0.5 g of benzoic acid moistened with 0.25 ml Milli-RO water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the patches

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: right flank of the rabbit
- % coverage: 6 cm2 Metalline on a permeable tape (Micropore).
- Type of wrap if used: a permeable tape (Micropore).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was cleaned first with a dry tissue and then by swabbed with a dampened tissue.
- Time after start of exposure: yes, after 4 hours of exposure

SCORING SYSTEM: no data available

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

0.5

Reversibility:

fully reversible

Remarks:

48 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test substance does not need to be labelled as a skin irritant.

Other effects:

Two animals showed slight erythema initially. 1 of these also showed slight oedema up to 24 h. This was resolved by 48 h. There was no indication of a systemic effect.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The dermal irritation potential of Benzoic acid was assessed according to OECD 404 (1981), EEC test method B.4, Annex V of EEC Directive 84/449/EEC (September 1984). The modified primary irritation index (PII) of 0.5 was recorded when benzoic acid was applied to the intact rabbit skin under semi-occlusive patch conditions.
Based on the scores, Benzoic acid can be considered to be not irritating to New Zealand albino rabbit skin.

Executive summary:

The dermal irritation potential of Benzoic acid was assessed according to OECD 404 (1981), EEC test method B.4, Annex V of EEC Directive 84/449/EEC (September 1984).

A paste, (0.5 g benzoic acid and 0.25 ml water), was applied evenly to 6 cm2 Metalline on a permeable tape (Micropore). This was applied to the right flank of 3 females New Zealand albino rabbits. A control patch without the test substance was applied to the left flank. These were left in place for 4 hours. The test site was cleaned first with a dry tissue and then by swabbed with a dampened tissue. The skin was examined for erythema, eschar formation and oedema at 1, 24, 48 and 72 hours after removal of the patches. Two animals showed slight erythema initially. 1 of these also showed slight edema up to 24 h. These effects were resolved by 48 h. There was no indication of a systemic effect. The modified primary irritation index (PII) of 0.5 was recorded when benzoic acid was applied to the intact rabbit skin under semi-occlusive patch conditions.

Based on the scores, Benzoic acid can be considered to be not irritating to New Zealand albino rabbit skin.