Registration Dossier
Registration Dossier
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EC number: 219-147-9 | CAS number: 2373-38-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was not performed under GLP compliance, however, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 957
- Report date:
- 1957
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA, 16cfr1500.41 CPSC
- Principles of method if other than guideline:
- FHSA: Federal Hazardous Substances Act
CPSC: Consumer Product Safety Commission - GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
- EC Number:
- 219-147-9
- EC Name:
- Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
- Cas Number:
- 2373-38-8
- Molecular formula:
- C16H30O7S.Na
- IUPAC Name:
- sodium 1,4-bis[(4-methylpentan-2-yl)oxy]-1,4-dioxobutane-2-sulfonate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Aerosol MA-80%, sodium dihexylsulfosuccinate
- Physical state: Clear, viscous liquid (80% solution)
- Analytical purity: 78-80%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: BV-1193A NH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: good stability in aqueous solution
- Storage condition of test material: Not provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Not provided
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 2.5, 5 and 10 mL/kg bw (corresponding to +- 9, 18 and 36 mL or gram)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 13
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 (H815)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 3 days to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 (H817)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 2 days to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #3 (H818)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 2 days to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #4 (H819)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; less than 1 day to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #5 (H821)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; less than 1 day to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #6 (H823)
- Time point:
- other: not specifed
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 7 days observation (survived))
- Irritation parameter:
- erythema score
- Basis:
- animal: #7 (H824)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 4 days to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #8 (H825)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 7 days observation (survived))
- Irritation parameter:
- erythema score
- Basis:
- animal: #9 (H826)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 7 days observation (survived))
- Irritation parameter:
- erythema score
- Basis:
- animal: #10 (H832)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 7 days observation (survived))
- Irritation parameter:
- erythema score
- Basis:
- animal: #11 (H833)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 4 days to death)
- Irritation parameter:
- erythema score
- Basis:
- animal: #12 (H835)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 7 days observation (survived))
- Irritation parameter:
- erythema score
- Basis:
- animal: #13 (H836)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided; 7 days observation (survived))
- Irritation parameter:
- edema score
- Basis:
- animal: #1 (H815)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #2 (H817)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #3 (H818)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #4 (H819)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #5 (H821)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #6 (H823)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #7 (H824)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #8 (H825)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #9 (H826)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #10 (H832)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #11 (H833)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #12 (H835)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritation parameter:
- edema score
- Basis:
- animal: #13 (H836)
- Time point:
- other: not specified
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: classification (no scoring provided)
- Irritant / corrosive response data:
- No scores available
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- At the dose of 10 mL test item/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL test item/kg bw, erythema and edema were initially quite severe, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days.
- Executive summary:
Single doses of the test item containing 80% active ingredient were applied to the closely-clipped skin of male rabbits for 24 hours under occlusion. Doses given were 2.5, 5 and 10 mL test item/kg body weight, corresponding with ca. 9, 18 and 36 g active ingredient. At the dose of 10 mL/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL/kg bw, erythema and edema were initially quite severe, but the edema subsided wihtin 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. The 2 latter doses were considered as worst case situation volumes (9 and 18 g instead of 0.5 g), therefore the substance is considered to be irritating but not corrosive to skin. There were no scores available.
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