Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Deficiencies: - occlusive dressing - two application sides (intact and abraded skin) - exposure period of 24 hours - examination of erythema and edema after 24/72 hours

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Hazardous Substances Regulations under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Deviations:
not applicable
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
The test material is identified by its trade name.
Specific details on test material used for the study:
- Test material code: 21825
- Physical state: maroon powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Ltd.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: average males: 2.22 kg, average females: 2.12 kg
- Housing: singly
- Diet (ad libitum): Labsure R14B
- Water (ad libitum): filtered water acidified to approx. pH3
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 +/- 1
- Humidity (%): 50-70%
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left side of the back: shaved, right side of the back: shaved and abraded
Vehicle:
other: polyethylene glycol 400
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
10g of the test compound was mixed with 10 ml of a 50% aqueous solution of polyethylene glycol 400 to make a suspension of 20 ml, 1.0 ml of which was applied to each test site on a 2.5 cm square gauze pad.

VEHICLE
- Concentration (if solution): 50%
Duration of treatment / exposure:
24 hours
Observation period:
6 days
Number of animals:
3 male and 3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: back
(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 sides lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand side 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 side remained intact.)
- % coverage: 10%
- Type of wrap if used: Gauze pads were covered with aluminium foil secured with "Transpore"-surgical tape. The test sites were then covered by a 6" wide "Coban" self adhesive bandage in order to retain the test substance in close contact with the skin.

SCORING SYSTEM:
Primary Irritation Score
0: Non irritating
0.1- 0.5: Minimally irritating
0.6 - 1.5: Slightly irritating
1.6 - 3.0: Mildly irritating
3.1 - 5.0: Moderately irritating
5.1 - 6.5: Severely irritating
6.6 - 8.0: Extremely irritating
(Draize et al. J. Pharmac. Exp. Ther. 82 377 1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact side of the animal (left side)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.1
Max. score:
4
Reversibility:
not fully reversible within: 6 days
Remarks on result:
other: Intact side of the animal (left side)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Abraded side of the animal (right side)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Abraded side of the animal (right side)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact side of the animal (left side)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact side of the animal (left side)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Abraded side of the animal (right side)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Abraded side of the animal (right side)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met