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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:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with OECD GLP regulations.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (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:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): MTDID 948
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 94.4%
- Purity test date: 16 April, 2014
- Lot/batch No.: 20014, Unit 027
- Expiration date of the lot/batch: 11 August, 2016
- Storage condition of test material: Ambient temperature

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/J
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: 18-24 grams
- Housing: Animals were group housed in labeled Makrolon cages (MIII type; height 18 cm) containing sterilized sawdust as bedding, paper and shelters as cage-enrichment.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days before the start of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Study design: in vivo (LLNA)

Vehicle:
other: Water
Concentration:
0 (1% L92 control), 10, 20, or 100 test article; % w/w
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 524 ppb +/- 10% at 20 C
- Irritation: 100% test article caused less than a 25% increase in ear thickness in a pre-screen test.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A stimulation index (SI) of greater than or equal to 3 indicates the test article may be regarded as a skin sensitizer.

TREATMENT PREPARATION AND ADMINISTRATION: The test article was prepared in water and 25 uL/ear applied to the dorsal surface of each ear.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The positive controls elicited a positive response.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The SI values calculated for the substance concentrations 10, 20, and 100% were 1.1, 0.9, and 1.1, respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Mean DPM/animal values for the experimental groups treated with the test substance concentrations of 0, 10, 20 and 100% were 496, 525, 424 and 523 DPM, respectively.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article did not show dermal sensitization potential.
Executive summary:

The dermal sensitization potential of the test article was determined in the Mouse Local Lymph Node Assay (LLNA). The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD Guideline 429 (2010). The test article was prepared in water at concentrations of 10, 20, or 100% w/w and experimental groups of five female CBA/J mice were treated with one of the concentrations on three consecutive days with 25 uL of the test solution. The test article was applied by open application on the dorsal surface of each ear. Five vehicle control animals were similarly treated. Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintigrations Per Minute (DPM) and stimulation indes (SI) was subsequently calculated for each group. No irritation of the ears was observed in any of the animals examined. All auricular lymph nodes of the animals of the experimental and controls groups were considered normal in size. No macroscopic abnormalities of the surrounding area were noted for any of the animals. Mean DPM/animal values for the experimental groups treated with the test substance concentrations of 0, 10, 20 and 100% were 496, 525, 424 and 523 DPM, respectively. The SI values calculated for the substance concentrations 10, 20, and 100% were 1.1, 0.9, and 1.1, respectively. Based on the results of the study, the test article did not show dermal sensitization potential.