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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
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 group
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 group
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 group
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 group
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.
Maximum concentration not causing irritating effects in preliminary test: 25 % Signs of irritation during induction: mild erythema and edema
Evidence of sensitisation of each challenge concentration:
A 25 %  0
A 0 %   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).
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.