Palmitoyl chloride

Endpoint summary

Description of key information

Palmitoyl chloride is sensitizing in a valid pre-guideline LLNA.

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:

comparable to guideline study with acceptable restrictions

Remarks:

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

Value:

2.1

Test group / Remarks:

5%

Parameter:

SI

Value:

3.3

Test group / Remarks:

10%

Parameter:

SI

Value:

4.5

Test group / Remarks:

25%

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 at the concentrations 10% and 25%, but not at 5%. Therefore, hexadecanoylchloride (palmitoyl chloride) 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 was observed at concentrations >= 10%. Therefore, hexadecanoylchloride (palmitoyl chloride) is regarded as sensitizing in the LLNA (Ashby, 1995).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data on skin sensitization the substance is classified as Skin Sens. Cat 1B (H317) according to criteria of Regulation EC/1272/2008 (CLP).

Respiratory sensitization classification is not warranted, as there are no known human case reports.