Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-01-30 to 2006-02-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006
Reference Type:
other: Expert report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: SPL Standard Test Method 595.12
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
no
Remarks:
The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): T745
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No data
- Expiration date of the lot/batch: No data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability under test conditions: No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No data

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
not specified
Details on test animals and environmental conditions:
Initial Body Weight: 18 - 20 grams

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
2.5%, 5%, 10% w/w
No. of animals per dose:
4
Details on study design:
Following a preliminary sighting test, at which there were no signs of systemic toxicity at a concentration of 10% w/w, three groups, each of four animals, were treated with 50 uL (25 uL per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 2.5, 5, and 10% w/w. A further group of four animals was treated with acetone/olive oil 4:1 alone. Animals received doses daily for three days. Clinical observations for signs of toxicity, mortality and body weight were made pre-dose and 1-hour post dose on days one through three. Daily observations were made for the following three days.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
other: 2,4-dinitrobenzenesulfonic acid, sodium salt; see below for other information on material and methods
Statistics:
No data

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.62
Test group / Remarks:
2.5% w/w
Remarks on result:
other: Negative
Parameter:
SI
Value:
1.35
Test group / Remarks:
5% w/w
Remarks on result:
other: Negative
Parameter:
SI
Value:
2.94
Test group / Remarks:
10% w/w
Remarks on result:
other: Negative
Parameter:
other: disintegrations per minute (DPM)
Value:
13 082.14
Test group / Remarks:
2.5% w/w
Parameter:
other: disintegrations per minute (DPM)
Value:
10 905.4
Test group / Remarks:
5% w/w
Parameter:
other: disintegrations per minute (DPM)
Value:
23 710.52
Test group / Remarks:
10% w/w
Parameter:
other: disintegrations per minute (DPM)
Value:
8 057.44
Test group / Remarks:
Vehicle

Any other information on results incl. tables

The test material was considered a non-sensitiser (SI<3) under the conditions of the test. There were no signs of toxicity or mortality at any time.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test material was considered to be a non-sensitiser under the conditions of the test. No mortality or signs of systemic toxicity were observed during the test.

T000745 is to be classified as a Skin Sensitizer 1B based on a Janssen expert statement following this study conclusion.