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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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Extrapolating local lymph node assay EC3 values to estimate relative sensitizing potency
Author:
Ryan CA, Kern PS, Dearman RJ, Kimber I and Basketter DA
Year:
2007
Bibliographic source:
Cutaneous and Ocular Toxicology, 26, 135-145, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 - 12 weeks

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0.5; 1.0; 2.5; 5.0; 10.0%
No. of animals per dose:
a minimum of 4 animals

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Vehicle (Acetone : olive oil): 1 Test material:  0.5%: 1.3 1.0%: 1.1 2.5%: 3.5 5.0%: 7.0 10.0%: 13.9
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Vehicle: 463 Test material: 0.5%: 597 1.0%: 486 2.5%: 1626 5.0%: 3223 10.0%: 6417

Any other information on results incl. tables

EC3: 2.2% (EC3 value derived by linear interpolation);

EC3: 2.3% (EC3 values derived by log-linear extrapolation).

Applicant's summary and conclusion