Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guide to Labeling of Dangerous Substances published in the Official Journal of European Communiites (EEC Directive 93/21, Annex VI).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 99%
-Physical Form: Purple to black flake.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Source: Hare Marland, Hewitt, New Jersey.
Housing: Single, in suspended, stainless steel, wire-mesh cages.
Food: Purina Certified High Fiber Rabbit Chow #5325, ad libitum, except during exposure.
Water: Ad libitum except during exposure.
Weight: 2074-2162 g
Light/Dark Cycle: 12/12
Temperature: 20ºC ± 1
Humidity: 50% ± 10%

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: other areas on test animals' body was used for comparison (control)
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, and 48 hours
Number of animals:
6
Details on study design:
On the day prior to treatment, the hair of 6 male rabbits was closely shaved to expose the skin from the scapular to the lumbar region of the back. Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting, approximately 8" x 18". The rabbits remained in the stocks throughout the exposure period and during that time did not have access to food or water. Approximately 0.5 g of the test substance, moistened with deionized water prior to dosing, was applied directly to the test site and was covered with a 2" gauze square. The gauze square was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure. Approximately 4 hours after application of the test substance, the rubber sheeting was loosened, and the skin at the corners of the gauze squares was marked with a waterproof pen. Wrappings and gauze squares were then removed. The test sites were gently washed with soap and warm water to remove excess test substance. The skin was gently patted dry and the animals were returned to their cages. Approximately 1, 24, and 48 hours after removal of the test substance, the test sites were evaluated for erythema, edema, and other evidence of dermal effects and were scored according to the Draize scale. The adjacent areas of the untreated skin were used for comparison. Additionally, the rabbits were examined for clinical signs of toxicity at each dermal evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
1.5
Max. score:
4
Reversibility:
other: not reversible in 48 hours
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48 h
Score:
1.5
Max. score:
4
Reversibility:
other: not reversible in 48 hours
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Evaluations made up to 48 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48 h
Score:
0
Max. score:
4
Remarks on result:
other: Evaluations made up to 48 hours
Irritant / corrosive response data:
The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed. By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema. Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.
See results tables 1 and 2 for further details.
Other effects:
In addition, the test sites of 2 rabbits were stained gray by the test substance. No clinical signs of toxicity were observed during the study.

Any other information on results incl. tables

TABLE 1:

Summary of Skin Response to the test substance

 

 

 

 

 

 

 

 

Erythema

Edema

Response

1 hr

24 hr

48 hr

1 hr

24 hr

48 hr

None

0/6

0/6

4/6

6/6

2/6

6/6

Slight

3/6

2/6

2/6

0/6

4/6

0/6

Mild

3/6

4/6

0/6

0/6

0/6

0/6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TABLE 2:

Individual Skin Irritation Scores
Skin Response Observed in Rabbits

 

 

 

 

 

 

 

Rabbit

Erythema

Edema

Number

1 hr

24 hr

48 hr

1 hr

24 hr

48 hr

30374

1

2

1

0

1

0

30383

1(x)

1(x)

0(x)

0

0

0

30384

2

2

0

0

1

0

30385

2(x)

2(x)

0(x)

0

1

0

30386

2

2

1

0

1

0

30392

1

1

0

0

0

0

 

 

 

 

 

 

 

(x) = skin stained gray

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed.  By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema.  Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.
Executive summary:

The irritation potential of the test substance was studied in rabbits. The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed.  By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema.  Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.