Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
20 females,nulliparous and non-pregnant
5 females per group.
Young animals adults were selected (approx. 9 weeks old), with body weight variation within +/- 20% of the sex mean.

ENVIRONMENTAL CONDITIONS
15 air changes per hour
temperature of 21.0 +/- 3°C
humidity range : 40-70%
12/12 hours dark/light.

Animals had free access to tap water and to pelleted rodent diet.

Study design: in vivo (non-LLNA)

No. of animals per dose:
five animals per dose, see above.

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
group animal numbers induction (test substance ; % w:w)
1 01-05 0 (DMF)
2 06-10 10
3 11-15 25
4 16-20 50
Details on study design:
Induction : the dorsal surface of both ears was topically treated (25µL/ear) with the test substance concentration, at approx. the same time on each day. The concentrations were stirred with a magnetic stirrer immediately prior to dosing.
The contro animals were treated in the same way as the experimental animals, except that the vehicle was administered instead of the test substance.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see attached document
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 335, 287 and 237 DPM respectively. the mean DPM/animal value for the vehicle control group was 277 DPM. See also the attached document

Any other information on results incl. tables

skin reaction/irritation :

very slight erythema observed on both eards of all animals at 50% on days 2 and 3 : considered not to have a toxicologically significant effect on the activity of the nodes.

systemic toxicity :

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

macroscopy of the auricular lymph nodes and surrounding area :

all auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. no macroscopic abnormality observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
the test item is considered as NOT SKIN SENSITIZER.
It does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the GHS system.