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 (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The protocoll used was the basis of the OECD Guideline 429 LLNA. However, it is a probably a non-GLP study with minor deviations to the OECD Guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
minor
Principles of method if other than guideline:
Method was according to Kimber and Basketter 1992
GLP compliance:
not specified
Remarks:
probably non-GLP
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details given
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, 25 %
No. of animals per dose:
not reported
Details on study design:
RANGE FINDING TESTS:
no details reported


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a stimulation index ≥ 3, together with consideration of dose-response


TREATMENT PREPARATION AND ADMINISTRATION:
Groups of mice are exposed daily, for 3 consecutive days, to various concentrations of the test chemical or to the relevant vehicle alone, on the dorsum of both ears. Subsequently on 5 days following the initiation of exposure, mice are injected intravenously with [3H]thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes (Kimber and Basketter, 1992).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Parameter:
SI
Remarks on result:
other: Concentration 5, 10, 25 Stimulation Index 3.8, 4.5, 4.0
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not reported
Executive summary:

Groups of mice are exposed daily, for 3 consecutive days, to various concentrations of the test chemical or to the relevant vehicle alone, on the dorsum of both ears. On day 5 following the initiation of exposure, mice are injected intravenously with [3H]thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes (Kimber and Basketter, 1992). A stimulation index ≥ 3, together was observed in all concentrations (5, 10, 25%). Therefore Octadecanoylchlorid is regarded as sensitizing in the LLNA.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a valid pre-guideline LLNA groups of mice are exposed daily, for 3 consecutive days, to various concentrations of the test chemical or to the relevant vehicle alone, on the dorsum of both ears. On day 5 following the initiation of exposure, mice are injected intravenously with [3H]thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes (Kimber and Basketter, 1992). A stimulation index ≥ 3, together was observed in all concentration. Therfore Octadecanoylchlorid (stearoylchloride) is regarded as sensitizing in the LLNA.


Migrated from Short description of key information:
Stearoylchloride (Octadecanoylchlorid ) is sensitizing in a valid pre-guideline LLNA similar to OECD 429.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

no test system nor data availiable

Justification for classification or non-classification

Stearoylchloride (Octadecanoylchlorid ) is sensitizing in a valid pre-guideline LLNA similar to OECD 429 and therefore classified as Skin Sens. Cat. 1B according to Annex I of Regulation EC/1272/2008 (CLP).