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Description of key information

The results of a local lymph node assay in mice exposed to the substance for three consecutive days indicates that the test material is a non-sensitiser in the skin.

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:
29th July 2016 to 21st August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
Deviations from the maximum level of daily mean relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations.
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA:J
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 (vehicle only), 10% w/w, 25% w/w, 50% w/w.
No. of animals per dose:
5/dose group
Positive control substance(s):
not specified
Key result
Parameter:
SI
Value:
>= 0.8 - <= 1.3
Test group / Remarks:
10, 25 and 50%

No irritation was observed in any of the animals. No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The majority of auricular lymph nodes were considered normal in size, except for the nodes in one of the animals treated at 25% and two of the animals treated at 50%. No macroscopic abnormalities of the surrounding area were noted for any of the animals.

Interpretation of results:
other: EU classification criteria not met
Conclusions:
The highest SI was 1.8 and given that this value is less than SI of 3 the substance would not be regarded as a skin sensitizer.
Executive summary:

In a local lymph node assay to evaluate the sensitisation potential of the substance mice were exposed to the test material at concentrations of 10, 25 or 50% for three consecutive days. The SI of 1.8 (highest) at 50% concentration indicates that the test material is not a sensitiser.

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

Based on the findings of a skin sensitisation study conducted on the substance, classification of the substance is not justified.