Registration Dossier
Registration Dossier
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EC number: 268-387-0 | CAS number: 68083-38-5
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 report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Results from an Acute Dermal lrritation /Corrosion Study (OECD 404) in Rats Using Benzenesulfonic acid, 4-methyl-
- Author:
- US Environmental Protection Agency Office of Pollution Prevention and Toxics (OPPT)
- Year:
- 2 013
- Bibliographic source:
- US Environmental Protection Agency Office of Pollution Prevention and Toxics (OPPT), 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To evaluate ocular irritation potential of 4-methyl benzene sulphonic acid on rabbit’s eye.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Toluene-4-sulphonic acid
- EC Number:
- 203-180-0
- EC Name:
- Toluene-4-sulphonic acid
- Cas Number:
- 104-15-4
- Molecular formula:
- C7H8O3S
- IUPAC Name:
- 4-methyl benzene sulphonic acid
- Test material form:
- solid: flakes
- Details on test material:
- - IUPAC name: 4-methyl benzenesulphonic acid
- Common Name: p-toluenesulphonic acid
- Molecular formula :C7H8O3S
- Molecular weight :190.218 g/mol
- Substance type:Organic
-InChI:1S/C7H8O3S/c1-6-2-4-7(5-3-6)11(8,9)10/h2-5H,1H3,(H,8,9,10)
-Smiles:S(c1ccc(C)cc1)(O)(=O)=O
- Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - IUPAC name: 4-methyl benzenesulphonic acid
- Common Name: p-toluenesulphonic acid
- Molecular formula :C7H8O3S
- Molecular weight :190.218 g/mol
- Substance type:Organic
-InChI:1S/C7H8O3S/c1-6-2-4-7(5-3-6)11(8,9)10/h2-5H,1H3,(H,8,9,10)
-Smiles:S(c1ccc(C)cc1)(O)(=O)=O
- Physical State: Solid
-Purity:65%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data available
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- undiluted test sample
- Duration of treatment / exposure:
- 5, 10, or 30 seconds
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Total = 9 ( 3 animals/exposure period)
- Details on study design:
- SCORING SYSTEM: Maximum Score = 110
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 5 sec
- Score:
- 83.6
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 10 sec
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 30 sec
- Score:
- 110
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The effects were not fully reversible within 14 days.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The overall irritation scores were 83.6, 110,110 for the 5,10 and 30 second exposures respectively. The effects observed were not fully reversible within 14 days.
Based on the scores and observations, 4-methyl benzenesulphonic acid can be considered to be corrosive to rabbit eyes. - Executive summary:
4-methyl benzenesulphonic acid was used as a test material to evaluate eye irritation potential on nine rabbits. The study was performed as per OECD 405 Guidelines.
Undiluted 4-methyl benzenesulphonic acid was instilled in the eyes of 9 rabbits for 5,10 or 30 seconds (3 animals for each duration). The rabbits were observed till 14 days for signs of irritation. The ocular reactions were scored with maximum score being 110.
The overall irritation scores were 83.6, 110,110 for the 5,10 and 30 second exposures respectively. The effects observed were not fully reversible within 14 days.
Based on the scores and observations, 4-methyl benzenesulphonic acid can be considered to be corrosive to rabbit eyes.
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