Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The skin of the tested animals was abraded and epidermal incisions were made prior to the application of the substance and the exposition lasted for 24 hours.
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:
Each rabbit was sexed, weighted and ear tagged. The weight ranged from 2.25kg to 2.55kg. The rabbits were quarantined and acclimated to laboratory conditions for 12 days. The animals were individually housed in steel wire-bottomed cages, suspended above the droppings. Animals were observed twice daily during the quarantine period.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: On each rabbit, two test sites were only clipped, the other two were also abraded.
Remarks:
24 hours prior to the dermal application an Oster small animal electric clipper was used on the backs of the animals.The clipped area was about 10% of the total body surface area.
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
0.5g of the test material was slightly moistened with physiological saline and applied to each of the test sites with a small plastic weight boat
Duration of treatment / exposure:
24h exposure
Observation period:
4 days
Number of animals:
6
Details on study design:
Six animals (3 males and 3 females) were selected after the quarantine period and weighted: the weight ranged from 2.25kg to 2.55kg.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The primary irritation index was calculated to be 1.
Other effects:
No other effects were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as irritant for skin.
Executive summary:

The primary skin irritation index was calculated to be 1 and all the effects were completely reversible after 72h, therefore the substance is not classified as irritant for skin.