Registration Dossier
Registration Dossier
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EC number: 410-290-4 | CAS number: 80693-00-1 ADK STAB PEP-36
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 September 1991 to 13 January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with internationally recognised guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- not specified
- Species:
- guinea pig
- Strain:
- other: Himalyayan spotted
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
1) Intradermique :
- substance testée diluée à 5 % avec alcool éthylique
- adjuvant complet de Freund à 50:50 avec de la solution
saline physiologique
- Substance testée émulsifiée et diluée à 5 % avec un
mélange d'ajdjuvant complet de Freund dans une solution
saline physiologique.
2) Epidermique :
- 25 % dans la vaseline
Application de laurylsulfate de sodium 24h avant le test
épidermique.
.
Concentration of test material and vehicle used for each challenge:
25 % dans la vaseline
. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
1) Intradermique :
- substance testée diluée à 5 % avec alcool éthylique
- adjuvant complet de Freund à 50:50 avec de la solution
saline physiologique
- Substance testée émulsifiée et diluée à 5 % avec un
mélange d'ajdjuvant complet de Freund dans une solution
saline physiologique.
2) Epidermique :
- 25 % dans la vaseline
Application de laurylsulfate de sodium 24h avant le test
épidermique.
.
Concentration of test material and vehicle used for each challenge:
25 % dans la vaseline
. - No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- 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: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- 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: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- 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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- 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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- From the results described above no allergenic potency of the test substance was concluded. The results were interpreted according to the rating of Magnusson and Kligman (1969).
Reference
Evidence of sensitisation of each challenge concentration:
A 25 % 0
A 0 % 0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Justification for selection of skin sensitisation endpoint:
Key study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- There were no adverse effects of the substance at a test concentration of 25% in any of the animals tested, in a Magnusson and Kligman maximisation test.
Justification for classification or non-classification
No finding observed at the highest concentration used for challenge application in a Magnusson and Kligman maximisation test.
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