Registration Dossier
Registration Dossier
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EC number: 271-807-5 | CAS number: 68608-88-8 This substance is identified by SDA Substance Name: C11-C13 branched alkyl benzene sulfonic acid and SDA Reporting Number: 25-096-00.
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- The study have been performed before the REACH legislation enters into force. This is the reason why only an in vivo experiment was performed.
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Laboratory study in experienced laboratory.
- Justification for type of information:
- Read Across to study conducted Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs EC 287-494-3, CAS 85536-14-7 considered scientifically justified due to structurally similarity.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation, other
- Remarks:
- The study have been performed before the REACH legislation enters into force. This is the reason why only an in vivo experiment was performed.
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Laboratory study in experienced laboratory.
- Justification for type of information:
- Read Across to study conducted Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs EC 287-494-3, CAS 85536-14-7 considered scientifically justified due to structurally similarity.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male and female white New Zealand rabbits weight between 3.7 and 6.0 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single treatment that was not washed out.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours and at 6 days after application.
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hrs and 6 days
- Score:
- 46.9
- Reversibility:
- not fully reversible within: 6 days
- Remarks on result:
- other: moderately irritating
- Irritant / corrosive response data:
- Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Result: moderately irritating
- Executive summary:
The eyes of six rabbits were treated with the related substance benzenesulfonic acid, 4 -C10 -13 -sec-alkyl derivs and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.
- EC Number:
- 287-494-3
- EC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.
- Cas Number:
- 85536-14-7
- Molecular formula:
- SO3C7H8-(CH2)n with n= 9-12
- IUPAC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs
- Details on test material:
- Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male and female white New Zealand rabbits weight between 3.7 and 6.0 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single treatment that was not washed out.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours and at 6 days after application.
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hrs and 6 days
- Score:
- 46.9
- Reversibility:
- not fully reversible within: 6 days
- Remarks on result:
- other: moderately irritating
- Irritant / corrosive response data:
- Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Result: moderately irritating
- Executive summary:
The eyes of six rabbits were treated with the related substance benzenesulfonic acid, 4 -C10 -13 -sec-alkyl derivs and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.
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