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Administrative data

Description of key information

According to the results of MEST in mice the substance is not to be classified with only 20% of sensitised animals and the swelling is below the threshold of 20% (here: 14%)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Mouse ear swelling test
GLP compliance:
not specified
Type of study:
mouse ear swelling test
Justification for non-LLNA method:
Existing study.
Species:
mouse
Strain:
CF-1
Sex:
female
Route:
epicutaneous, open
Vehicle:
other: Ethanol 95%
Concentration / amount:
50%
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: Ethanol 95%
Concentration / amount:
50%
No. of animals per dose:
10-15 (control 5-10)
Details on study design:
On the first day of the study the animals abdomens were clipped and tape stripped and two intradermal injections totaling 0.05 ml of Freund's Complete Adjuvant were administered.
A 50% solution in 95% ETOH, 100 μl, was applied to the shaved area on the first day and the following 3 days, with the skin being tape stripped before each application.
After a 7 day nontreatment period, a topical application of 20 μl of a 50% solution in 95% ETOH, was made to the left ear of the mouse while the right ear received 20 μl of the vehicle alone.
The ear thickness was measured 24 and 48 h after the challenge application.
Reading:
1st reading
Group:
test chemical
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
The percentage swelling was reported as 114%, with a value of 100% indicating no swelling.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of MEST in mice the substance is not to be classified with only 20% of sensitised animals and the swelling is below the threshold of 20% (here: 14%)
Executive summary:

According to the results of MEST in mice the substance is not to be classified with only 20% of sensitised animals and the swelling is below the threshold of 20% (here: 14%)

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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

According to the results of MEST in mice the substance is not to be classified with only 20% of sensitised animals and the swelling is below the threshold of 20% (here: 14%).