Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from October 3rd, 1988 to October 7th, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guideline B.4 of the EEC Directive 84/449/EEC and OECD guideline N°404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
test substance was applied under occlusive conditions without justification
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
test substance was applied under occlusive conditions without justification
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A c. 700 g sample of the test substance was received from the sponsor on
September 19, 1988. It consisted of a fine, white powder, designated:
“AF-366”. Just prior to application, the test substance was mixed with
water in a ratio of 1:1, by weight.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as experimental
animals. Age at study initiation: young adult.
The body weight range was 2571—3108 g. The animals were
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front.
Acclimation period : 6 days.
The cages were placed in a room, controlled for light (12 hours light/12 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water were provided ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
1:1 ratio of test substance and water
Controls:
other: not required, the untreated site of the same rabbit served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 g
- Concentration (if solution): 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: a shaved, 2.5 cm diameter area on the back or flank of the rabbit
- Type of wrap if used: a plastic cup with the test solution (0.5 g test substance, 0.5 g water) was placed on an area of intact skin and fixed to the application site by means of adhesive tape (Leukopor, BDF). The entire trunk of the rabbit was wrapped with self-adhesive gauze (Fixomull, art. No. 2112, BDF, Germany) to hold the cup in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was removed from the skin area after exposure ended
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
There were no skin irritation reactions at any time point in any animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the resuits obtained it is conciuded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Coxumunities, L 257, Volume 26,
16 September 1983), “AF—366” is not irritating or corrosive to skin.