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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:
29th July 2016 to 21st August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
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 lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female

Study design: in vivo (LLNA)

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

Results and discussion

In vivo (LLNA)

Results
Key result
Parameter:
SI
Value:
>= 0.8 - <= 1.3
Test group / Remarks:
10, 25 and 50%

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.