Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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: Comparable to guideline study with acceptable restrictions (limited reporting).

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Comparison of the local lymph node assay with the guinea-pig maximization test for the detection of a range of contact allergens
Author:
Basketter DA, Scholes EW
Year:
1992
Bibliographic source:
Food Chem. Toxicol. 30, 65-69
Reference Type:
publication
Title:
The performance of the local lymph node assay with chemicals identified as contact allergens in the human maximization test
Author:
Basketter DA, Scholes EW, Kimber I
Year:
1994
Bibliographic source:
Food Chem Toxicol. 32, 543-547

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
limited reporting
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Aniline
EC Number:
200-539-3
EC Name:
Aniline
Cas Number:
62-53-3
Molecular formula:
C6H7N
IUPAC Name:
aniline
Details on test material:
Supplier: Aldrich Chemical Co., Gillingham, Dorset, UK
Purity: no data

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
male/female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25, 50%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: 1.4, 1.8 and 2.9 for 10, 25, 50% aniline respectively; no EC3 value could be calculated since the highest tested concentration of 50% aniline did induce a stimulation index of below 3.

Any other information on results incl. tables

No EC3 value could be calculated since the highest tested concentration of 50% aniline did induce a stimulation index of below 3. EC3 therefore is > 50%.

Applicant's summary and conclusion