Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
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.