Lauroyl chloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

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

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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:

Nonanoyl chloride

EC Number:

212-131-2

EC Name:

Nonanoyl chloride

Cas Number:

764-85-2

IUPAC Name:

nonanoyl chloride

Constituent 2

Reference substance name:

Palmitoyl chloride

EC Number:

203-996-7

EC Name:

Palmitoyl chloride

Cas Number:

112-67-4

IUPAC Name:

hexadecanoyl chloride

Constituent 3

Reference substance name:

Stearoyl chloride

EC Number:

204-004-5

EC Name:

Stearoyl chloride

Cas Number:

112-76-5

IUPAC Name:

octadecanoyl chloride

Details on test material:

Nonanoyl chloride, CAS 764-85-2;
Palmitoyl chloride (= Hexadecanoyl chloride), CAS 112-67-4;
Stearoyl chloride (= Octadecanoyl chloride), CAS 112-76-5

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)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see table below

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: not reported

Any other information on results incl. tables

Name	CAS NR	Vehicle	% Concentration	T/C Ratio (Stimulation Index)
Nonanoyl Chloride	764 -85 -2	AOO	5, 10, 25	12.7, 19.4, 20.9
Hexadecanoyl Chloride	112 -67 -4	AOO	5, 10, 25	2.1, 3.3, 4.5
Octadecanoyl Chloride	112 -76 -5	AOO	5, 10, 25	3.8, 4.5, 4.0

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

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 all concentration for Nonanoyl chloride and Octadecanoyl chloride. For Hexadecanoyl chloride a SI ≥ 3 was observed for the concentrations 10% and 25%. Therefore, Nonanoyl chloride, Hexadecanoyl chloride and Octadecanoyl chloride are regarded as sensitizing in the LLNA. Due to structural similarities, Lauroyl chloride is also regarded as a skin sensitizer.