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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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