Diphenylacetic acid

Eye irritation

Administrative data

Endpoint:

eye 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:

OPINION ON Benzoic Acid and Sodium Benzoate

Author:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP)

Year:

2005

Bibliographic source:

SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP) -21 June 2005- SCCP/0891/05

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC test method B.5, Annex V of EEC Directive 84/449/EEC

Principles of method if other than guideline:

Mucous membrane irritation study of Benzoic acid was conducted in 3 female New Zealand albino rabbit to determine its effects on eyes.

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 : C7H6O2
- 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 : C7H6O2
- 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

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or tissues and environmental conditions:

sex: female

Test system

Vehicle:

not specified

Controls:

other: The untreated left eye was used as a control

Amount / concentration applied:

77mg as a fine powder

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

immediately after dosing, 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment.

Number of animals or in vitro replicates:

3(female)

Details on study design:

- Area of exposure: The test substance was poured into the right conjunctival sac.

SCORING SYSTEM: Draize score

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hour

Score:

35

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

After 60 min, Animal 1 showed no reaction to light, with translucent corneal opacity and iridial injection. The other 2 also had slight corneal opacity. All 3 had moderate chemosis and slight conjunctival redness. The corneal opacity noted in the first animal increased to nacreous areas. This persisted for 72 h. The translucent areas of opacity persisted up to Day 21. In Animal 2, the slight corneal opacity also persisted up to Day 21, but was resolved in Animal 3 by Day 7. By Day 14, in Animal 1, the iridial injection was resolved but no reaction to light. Animal 2 showed iridial injection on Day 2. The slight conjunctival redness in all animals increased to severe with a white/grey discolouration. It persisted in Animals 1 and 2 up to Day 21 and in Animal 3 to Day 7. The chemosis decreased slowly. In Animals 1 and 2, it was not completely resolved by Day 21 but it was resolved in Animal 3 by Day 14. The animals did not show any symptoms of systemic intoxication.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

After 60 min, Animal 1 showed no reaction to light, with translucent corneal opacity and iridial injection. All 3 rabbits had moderate chemosis and slight conjunctival redness. The rabbits did not show any symptoms of systemic intoxication.The estimated Draize score of 35 (60 min) is classed as severely irritating according to Kay and Calandra.
Based on these observations and score, Benzoic acid (CAS No: -65-85-0) was considered to be an eye irritant to the female New Zealand albino rabbit.

Executive summary:

Eye irritation study was carried out for Benzoic acid(CAS No: -65-85-0) in 3 female New Zealand albino rabbits. The study was performed in accordance with EEC test method B.5, Annex V of EEC Directive 84/449/EEC.

 

77 mg of Benzoic acid (as a fine powder) was instilled into the right conjunctival sac of 3 rabbits (single application). After application, the lids of the treated eye were held closed for approximately two seconds. The untreated left eye served as a control. The degree of eye irritation wasevaluated at immediately after dosing, 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment. The mean Draize scores were classified according to Kay and Calandra rating for eye irritation.

 

After 60 min, Animal 1 showed no reaction to light, with translucent corneal opacity and iridial injection. The other 2 also had slight corneal opacity. All 3 had moderate chemosis and slight conjunctival redness. The corneal opacity noted in the first animal increased to nacreous areas. This persisted for 72 h. The translucent areas of opacity persisted up to Day 21. In Animal 2, the slight corneal opacity also persisted up to Day 21, but was resolved in Animal 3 by Day 7. By Day 14, in Animal 1, the iridial injection was resolved but no reaction to light. Animal 2 showed iridial injection on Day 2. The slight conjunctival redness in all animals increased to severe with a white/grey discolouration. It persisted in Animals 1 and 2 up to Day 21 and in Animal 3 to Day 7. The chemosis decreased slowly. In Animals 1 and 2, it was not completely resolved by Day 21 but it was resolved in Animal 3 by Day 14. The animals did not show any symptoms of systemic intoxication.

 The estimated Draize score of 35 (60 min) is classed as severely irritating according to Kay and Calandra.

Based on these observations and score, Benzoic acid (CAS No: -65-85-0) was considered to be an eye irritant to the female New Zealand albino rabbit.