Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From June 32 to July 25, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study following official guideline not in GLP

Data source

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

Materials and methods

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

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Number of animals: 6 (3 male; 3 female)
- Age at study initiation: 9 -14 weeks
- Weight at study initiation: 2.15 (male); 2.75 (female)
- Housing: singly caged
- Diet : commercial irradiated diet (Syles Oxoid), ad libitum
- Water : ad libitum for all test duration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ± 2°
- Relative humidity: 50-70 %
- Photoperiod (hrs dark / hrs light): 10 hours of light (8:00-18:00)

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
other: non abraded part of the skin area considered
Amount / concentration applied:
10 g of the test compound was mixed with 10ml of water to make a solution of 15ml. 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
24 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 sits remained intact.
These were 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.

REMOVAL OF TEST SUBSTANCE
After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema.
A further assessment was made at 72 hours.

SCORE SYSTEM
The assessment of the macroscopic skin reaction was made according to the Draize et al. 3. Pharmac. Exp. Ther. 82 377 1944.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary Irritation score
Basis:
mean
Time point:
other: 72 h
Score:
1.2
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
2.17
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritant / corrosive response data:
Slight erythema was seen on 2/6 abraded sites and slight to moderate oedema was seen on all sites, 24 hours after application of the compound. All sites were normal by 72 hours.
See table for further details.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Slight erythema was seen on 2/6 abraded sites and slight to moderate oedema was seen on all sites, 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 1.2.
Executive summary:

The determination of skin irritation was determined in an a Primary Skin Irritation test. No guideline has been followed and the test has not been performed in compliance with the GLP Regulation. The substance has been tested in albino rats for 72 h. Erythema and oedema formation have been observed.

Slight erythema has been observed on 2/6 abraded sites and slight to moderate oedema have been observed on all sites, 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 1.2