Registration Dossier

Administrative data

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:
other information
Study period:
Jan-Feb 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance/animal)
Challenge: 50% and 25% (= 250 mg and 125 mg test substance/animal)
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance/animal)
Challenge: 50% and 25% (= 250 mg and 125 mg test substance/animal)
No. of animals per dose:
control group: 10
test substance group: 20
dose range-finding groups: 1 (for intracuteneous induction), 4 (for topical indiction), 5 (for challenge)
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge 50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Challenge 25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: Challenge 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Challenge 50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Challenge 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
Challenge 25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Challenge 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Appearance and behaviour of the test substance group were not different from the control groups with the following exceptions: two animals of the treatment group showed bloody wounds and encrustations in places on the treatment areas after the 2nd induction (beginning on day 9, healing by day 14 or 15). No mortalities occurred. The body weight development of the treatment group animals corresponded to that of the control group.

Executive summary:

To determine the skin-sensitizing properties of N-Formylaminosorbit the guinea pig maximization test was performed on female guinea pigs according to OECD guideline 406. The study was conducted with the following test substance concentrations:

intradermal induction: 5%

topical induction: 50%

challenge: 50% and 25%

Since the substance was found to be not irritating in the range-finding study, the treatment areas of the animals were pre-stimulated with sodium lauryl sulfate prior to the second induction.

Under the condition of the maximization test and with respect to the evaluation criteria N-Formylaminosorbit exhibited no skin-sensitization potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Neither the test substance group animals nor the controls exhibited dermal reactions in the Guinea Pig Maximization Test following challenges with 50% and 25% test substance formulation.

Therefore, under the conditions of the test N-Formylaminosorbit showed to be no skin sensitizer.


Migrated from Short description of key information:
Skin Sensitisation, Maximization Test according to Magnusson and Kligman (Guinea pig, GLP, OECD TG 406, EU Method B.6): not sensitizing
[Bayer AG, Report No. 23871, 1995-03-27]

Justification for selection of skin sensitisation endpoint:
only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) for skin sensitization is not required.