Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
An area of at least 6 cm2 was shaved on both flanks of the animals approx. 24 hours before treatmnet.
0.5 g of the test compound was applied to each test site on a 3 cm square surgical gauze pad (20 cm2).
This were covered with aluminium foil (36 mm2) and then covered with an occlusive dressing for 4 hours.
The dressing was wrapped with an adhesive tape (isoplast AG, CH).
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and for other 7 days
Number of animals:
3 male rabbits
Details on study design:
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of all animals
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
other: mean of all animals
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritant / corrosive response data:
No irritation effect observed on all animals.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other effects:
Coloration: in the area of application a clear visible red stained of the test skin was observed in animals 76 and 77 up to 48 hours and in animal 75 up to 72 hours which could be related to effects of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
OECD GHS
Conclusions:
Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.
Executive summary:

The primary irritation score was assessed following OECD 404.

The results show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under Regulation EC 1272/2008 .