Registration Dossier
Registration Dossier
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EC number: 907-578-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69 EEC, B.4 OECD 404 OPPTS 870.2500
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: NZW Crl:KBL BR
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Carboxymethylcellulose (1 % aqua bidest)
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Other effects:
- none
- Interpretation of results:
- other: not classified
- Conclusions:
- The test item is not classified as a skin irritant.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69 EEC, B.4 OECD 404 OPPTS 870.2500
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 433-100-1
- EC Name:
- -
- IUPAC Name:
- Reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and lithium hydroxide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: NZW Crl:KBL BR
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Carboxymethylcellulose (1 % aqua bidest)
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
