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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed not in GLP, according to the U.S federal guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
The substance was suspended in tap water before the administration.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
Strain: Porton
Age at study initiation: 9-13 weeks
Weight at study initiation: 2.36 Kgs. (males) and 2.55 Kgs (female)
Housing: maintained under a semi-barrier system. Caged singly in an experimental room
Diet: bred on the premises and maintained under a semi-barrier system. Commercial irradiated diet (Styles-Oxoid) was fed ad lib
Water: ad libitum, Sterile filtered
Acclimation period: acclimatized in the test area for one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
Temperature: 20 °C +/- 1°C
Humidity: 50-70 %
Photoperiod (hrs dark / hrs light): from 08.00 - 18.00 hours artificial light

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
72 hours
Observation period:
24,72 hours
Number of animals:
6 rabbits (3 males) (3 female)
Details on study design:
PREPARATION OF THE SKIN
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
COVER
After the application covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self
adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all six animals
Time point:
72 h
Score:
0
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
animal: two animals/6
Time point:
72 h
Score:
0.5
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
animal: three animals/6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0.5
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: tree animals/6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: two animals/6
Time point:
72 h
Score:
1.5
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
animal: four animals/6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
A slight to well defined erythema was seen on 5/6 abraded sites and a very slight to moderate oedema on 4/6 intact and 6/6 abraded sites, 24 hours after application of the compound. At 72 hours very slight oedema was still present on one abraded site. The primary irritation score was 1.2.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Criteria used for interpretation of results: other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Conclusions:
Slight primary skin irritant
Executive summary:

The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous

Substances Labelling Act Sect. 191.11 (February 1965).

To a prepared skin (intacted and abraded) of six rabbits (3 male, 3 female) 10 g of the test compound was mixed with 10 ml of water (to make a solution of 15 ml) 0.75 ml of which was applied to each test site on a 2.5 cm,, square gauze pad and covered.

Observation was done at 24 and 72 hours.

A slight to well defined erythema was seen on 5/6 abraded sites and a very slight to moderate oedema on 4/6 intact and 6/6 abraded sites, 24 hours after application of the compound. At 72 hours very slight oedema was still present on one abraded site. The primary irritation score was 1.2.

According to the method used the substance is a slight primary skin irritant in the albino rabbit.