Registration Dossier
Registration Dossier
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EC number: 422-310-9 | CAS number: 114772-53-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not declared
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study was provided us by ECHA under the 12 years rule. Available data contain scanty study details: the limited amount of information and the lack of the full study report do not allow a proper reliability assessment.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)
- IUPAC Name:
- EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals and environmental conditions:
- Albino Hartley guinea pig (Charles River France)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 10% in Ethanol (abs.)
b) dermal: 63% in Ethanol (abs.)
Concentration of test material and vehicle used for each challenge:
dermal: 63% in Ethanol (abs.)
Challengeopen allclose all
- Route:
- other: dermal, not otherwise specified
- Vehicle:
- other: ethanol
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 10% in Ethanol (abs.)
b) dermal: 63% in Ethanol (abs.)
Concentration of test material and vehicle used for each challenge:
dermal: 63% in Ethanol (abs.)
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary study.
Signs of irritation during induction: animals were treated with sodium lauryl sulfate 10% before induction, and irritating effects were observed after treatment with sodium lauryl sulfate.
Evidence of sensitization of each challenge concentration:
- treated group: 1/20
- control group: 0/10
During the study, changes in temperature were recorded (19 +/- 3°C with a maximum temperature of 25,7°C). These changes did not affect study results.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for skin sensitisation.
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