Acid chlorides, coco

Skin sensitisation

Administrative data

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 protocol 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

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Structure activity relationships in skin sensitization using the murine local lymph node assay

Author:

J. Ashby, D.A. Basketter, D. Paton, I. Kimber

Year:

1995

Bibliographic source:

Toxicology, 103, 177-194

Reference 2

Reference Type:

secondary source

Title:

ICCVAM Evaluation of the Murine Local Lymph Node Assay

Author:

Karen E. Haneke, Raymond R. Tice, Bonnie L. Carson, Barry H. Margolin and William S. Stokes

Year:

2001

Bibliographic source:

Regulatory Toxicology and Pharmacology 34, 274-286

Materials and methods

Test 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)

Test material

Test material information

Constituent 1

Reference substance name:

Palmitoyl chloride

EC Number:

203-996-7

EC Name:

Palmitoyl chloride

Cas Number:

112-67-4

Molecular formula:

C16H31ClO

IUPAC Name:

hexadecanoyl chloride

Details on test material:

Hexadecanoyl chloride, no further data
"Coco acid chlorides" is a natural occuring mixture of Lauryl-, Mysityl- and Palmitoyl chloride (Hexadecanoyl chloride; approx. 10%)

In vivo test system

Test animals

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no details given

Study design: in vivo (LLNA)

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)

mercaptobenzothiazole (CAS No 149-30-4)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Concentration 5, 10, 25 Stimulation Index 2.1, 3.3, 4.5

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: not reported

Applicant's summary and conclusion

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 was observed in concentrations >5%. Hexadecanoylchlorid is regarded as sensitizing in the LLNA