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Description of key information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard guideline study; GLP
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/J
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: ca 8 weeks
- Weight at study initiation: 19 - 24 g
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad ibitum
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25 C
- Humidity (%): 30 to 50 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 - 10 - 25 - 50 %
No. of animals per dose:
3
Details on study design:
TREATMENT PREPARATION AND ADMINISTRATION:
Animals were anesthetized by inhalation of isoflurane. The test material was applied to the back of the ears at a volume of 25µL per ear of the respective preparation. Administration was perform once a day for three consecutive days. The control animals were treated accordingly using the vehicle only.
Parameter:
SI
Remarks on result:
other: S.I. Control - 10 % 0,72 25 % 0,68 50 % 0,49
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: DPM/group No. of nodes DPM/node Control 2317,05 10 225,86 10 % 1677,95 10 161,95 25 % 1583,91 10 152,55 50 % 1163,53 10 110,51
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item showed no indication of a skinn sensitizing potential in the local lymph node assay in mice.
Executive summary:

After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %. The stimulation index varied between 0,72 and 0,49.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %.The stimulation index varied between 0,72 and 0,49. The limit for positive effects was not reached. The test item was judged as non sensitising.

This conclusion was also confirmed by a Maximisation test on an structurally similar analoguous substance.


Migrated from Short description of key information:
After treatment of four groups of female CBA/J mice with the test item in acetone/olive oil (4/1) topically on the back of the ears on three consecutive days no proliferation of the draining lymph nodes was recorded as shown by a lack of increased incorporation of 3H-Thymidine in lymph node cells. The volume applied was 25 µL and the concentrations were 10 , 25, and 50 %. The stimulation index varied between 0,72 and 0,49.

Justification for selection of skin sensitisation endpoint:
recent guideline study under GLP, target substance tested,

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification; Based on the negative result of the LLNA test no skin senstisation potential is expected.