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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
Study period:
March 18 - July 06, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Identification: Art. 139222 (HTM-081)
Batch: OS11008922
Purity (HPLC): >99.95 % (Area %)
Appearance: Pale yellow powder without visible impurities
Expiry Date: 15 August 2016
Storage Conditions: At room temperature, protected from light and moisture
Stability in Solvent: Not indicated by the sponsor
Purpose of Use: Industrial Chemical

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 9-10 weeks; Main test: 8 - 9 weeks
- Weight at study initiation: Pre-test: 20.5 g; Main test: 19.5+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
5, 10, and 25 (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 25% in PG
- Irritation: No
- Lymph node proliferation response: -

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3

TREATMENT PREPARATION AND ADMINISTRATION:
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Positive control results:
Conc. SI
0%: 1.00
5% 1.93
10% 2.65
25% 9.48

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.6
Test group / Remarks:
Test Group: 5%
Parameter:
SI
Value:
1.06
Test group / Remarks:
Test Group: 10%
Parameter:
SI
Value:
1.14
Test group / Remarks:
Test Group: 25%

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP
Conclusions:
The test item Art. 139222 (HTM-081) was not a skin sensitiser under the test conditions of this study.
Executive summary:

The test item Art. 139222 (HTM-081) was not a skin sensitiser under the test conditions of this study.