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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:
From 2013-09-25 to 2014-01-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Report of study in accordance with OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch: 110801
Purity: 99.8%
Test substance storage: At room temperature in the dark under nitrogen
Stable under storage conditions until 26 August 2018 (expiry date)
pH (1% in water, indicable range) 8.0-9.0

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Weight at study initiation: variation was within +/- 20% of the sex mean.
- Housing: 5 animals
- Diet (e.g. ad libitum):ad libitum to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum):ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 to 24°C
- Humidity (%):40 to 70%
- Air changes (per hr):approximately 15 room air changes/hour
- Photoperiod (hrs dark / hrs light):12-hour light/12-hour dark cycle.

IN-LIFE DATES: From: 2013-10-09 To: 2014-11-11

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
10, 25 and 40%
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: Two test substance concentrations were tested; a 40% and 25% concentration. The highest concentration was the highest concentration that could be prepared homogeneously.
- Irritation:
- Lymph node proliferation response: Not observed.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group.
The SI is the ratio of the DPM/group compared to DPM/vehicle control group.
If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer.

TREATMENT PREPARATION AND ADMINISTRATION:
-Induction(Days 1,2 and 3)
The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance concentration, at approximately the same time on each day.
-Excision of the nodes(Day 6)
Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) (Merck, Darmstadt, Germany) containing 20 μCi of 3H-methyl thymidine (PerkinElmer Life and Analytical Sciences, Boston, MA, US).
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
0.8
Test group / Remarks:
10% concentration
Parameter:
SI
Value:
1
Test group / Remarks:
25% concentration
Parameter:
SI
Value:
0.7
Test group / Remarks:
40% concentration

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Based on these results, the test substance would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test substance does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011)(including all amendments)and theRegulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).