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Description of key information

Since there was no indication that the test substance elicits an SI >= 3 when tested up to 50%, the test substance was considered to be a non skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 May - 26 May 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 12 weeks
- Weight at study initiation: 22 to 25 gram
- Housing: Individual housing in Macrolon cages (MI type; height 12.5 cm) containing sterilized sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: at least 5 days before the start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3 to 23.6
- Humidity (%): 41 to 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
other: Ethanol/water (7:3 v/v)
Concentration:
Preliminary study: A series of two test item concentrations was tested, selected from the series: 100% (undiluted), 50%, 25%, 10%, 5%, 2.5%, 1% and if needed further lower concentrations using the same steps. The highest concentration, selected from this series, was the 50% concentration.

Main study: 10, 25, 50 %
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: not indicated
- Irritation: slight erytheman at 50% concentration after 3 days
- Lymph node proliferation response: No lymph nodes were excised.


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- 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, based on the test guideline and recommendations done by ICCVAM



TREATMENT PREPARATION AND ADMINISTRATION: Animals received topical test and control items on the dorsum of both ears once a day on 3 consecutive days. 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.
Positive control substance(s):
other: 0.5% 1-Chloro-2,4-Dinitrobenzene
Positive control results:
The SI value for the positive control substance, DNCB, was 17.4.
The SI value for the positive control substance (vehicle Ethanol/water; 7:3 v/v) and the six monthly reliability check with Hexylcinnamaldehyde, (vehicle Acetone: Olive oil (4:1)) indicate that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
Key result
Parameter:
SI
Value:
0.5
Test group / Remarks:
test substance concentrations 10%
Key result
Parameter:
SI
Value:
0.7
Test group / Remarks:
test substance concentrations 25%
Key result
Parameter:
SI
Value:
1.1
Test group / Remarks:
test substance concentrations 50%

The irritation of the ears as shown by the animals, was considered not to have a toxicologically significant effect on the activity of the nodes.

All nodes of the experimental and vehicle control group were considered normal in size. The nodes of the positive control group were enlarged.

No macroscopic abnormalities of the surrounding area were noted.

Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.

No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Since there was no indication that the test substance elicits an SI >= 3 when tested up to 50%, the test substance was considered to be a non skin sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification