Registration Dossier
Registration Dossier
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EC number: 401-300-8 | CAS number: 86168-95-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- 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:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: epidermal & challenge exposure: vaseline
- Concentration / amount:
- - Concentration of test material and vehicle used at induction:
Intradermal (0.1 mL)
a) adjuvant/saline 1:1
b) test substance 1% in sesame oil
c) test substance 1% in the saline/adjuvant 1:1 mixture
Epidermal (approx. 0.4 g)
test substance 30% in vaseline
- Concentration of test material and vehicle used for each challenge:
Epidermal (approx. 0.2 g)
10% of the test substance in vaseline
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- other: epidermal & challenge exposure: vaseline
- Concentration / amount:
- - Concentration of test material and vehicle used at induction:
Intradermal (0.1 mL)
a) adjuvant/saline 1:1
b) test substance 1% in sesame oil
c) test substance 1% in the saline/adjuvant 1:1 mixture
Epidermal (approx. 0.4 g)
test substance 30% in vaseline
- Concentration of test material and vehicle used for each challenge:
Epidermal (approx. 0.2 g)
10% of the test substance in vaseline
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- 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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- 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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
The field "Clinical observations" cannot be provided because the NONS file (provided by ECHA) doesn't contain this information.
Number of animals showing evidence of sensitisation at challenge concentration (10%): 0/20 of the animals showed sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classified as sensitising to the skin.
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