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Toxicological information

Skin sensitisation

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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: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 429 with acceptable restrictions (partly limited documentation, e.g. no details about test substance, test animals, no. of animals used). Validity is sufficient since the authors are the founder of the corresponding OECD Guideline 429 (see principles of the method).

Data source

Reference
Reference Type:
publication
Title:
Structure activity relationships in skin sensitization using the murine local lymph node assay
Author:
Ashby J, Basketter DA, Paton D, Kimber I
Year:
1995
Bibliographic source:
Toxicology 103: 177-194

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Principles of method if other than guideline:
The authors used the method published in 1) Kimber, I. (1992) Contact sensitivity . In : K . Miller, I. Turk and S. Nicklin (Eds). Principles and Practice of Immunotoxicology. Blackwell Scientific Publications, Oxford, pp 104-124 and 2) Kimber, I. and Basketter, D .A. (1992) The murine local lymph node assay: a commentary on collaborative studies and new directions. Fd. Chem . Toxicol. 30, 165-169. These publications are the basis for the OECD Guideline 429 (adopted 2002).
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
2.5, 5, 10%
No. of animals per dose:
No data
Details on study design:
Open application of unknown amount of the appropriate dilution of the test substance or the vehicle alone to the dorsum of each ear; days 2 and 3: repeated application like day 1. Five days following the initiation of experiment the mice received i.v. 3H-thymidine; activity measured as a function of incorporation into the draining auricular lymph nodes. No further details.
Positive control substance(s):
other: In parallel experiments other test substances were assayed and positive results were obtained.
Statistics:
no data

Results and discussion

Positive control results:
Several other test substances in parallel experiments gave positive results

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The index was 1.2, 1.0, and 1.6 at 2.5, 5, 10% test substance in vehicle, respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: no details

Any other information on results incl. tables

No data were given on clinical signs or body weight.

Screening of 106 chemicals.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance has no sensitising properties in the local lymph node assay.
Executive summary:

The study is comparable to OECD Guideline 429 with acceptable restrictions (partly limited documentation, e.g. no details about test substance, test animals, no. of animals used).

In the local lymph node assay groups of mice received open applications of 0, 2.5, 5, or 10% of the test substance in the vehicle (acetone, olive oil, 4:1 v/v) to the dorsum of each ear; days 2 and 3 this procedure was repeated. Five days following the initiation of experiment the mice were injected i.v. with 3H-thymidine; the activity was measured as a function of incorporation into the draining auricular lymph nodes. The stimulation index was 1.2, 1.0, and 1.6, respectively. The results were negative (a positive response includes a stimulation index ≥ 3).

Conclusion: The test substance has no sensitising properties in the local lymph node assay.