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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:
1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
application to intact and to abraded skin, 24h exposure, occlusive wrapping, area 25 cm2.
Principles of method if other than guideline:
- Method according to Draize JH, Woodward G, Calvery HO (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes, Journal of Pharmacology and Experimental Therapeutics November 1, 1944, 82 (3) 377-390 (see 'Attached background material').
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Neo-DHC, Lot #26-RS-17, received date 8/11/78.
- Purity (HPLC): 98.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Six albino New Zealand rabbits (3 males, 3 females), each abraded and non-abraded, no further details.

Test system

Type of coverage:
occlusive
Preparation of test site:
other:
Remarks:
clipped or abraded.
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5mL
Duration of treatment / exposure:
24h.
Observation period:
72h.
Number of animals:
6 (3 males, 3 females)
Details on study design:
TEST SITE
Test performed on clipped and also on abraded skin areas. Applications were made under occlusive patches; following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping. The animals were then immobilised.
- Area of exposure: 2x2in (~25cm2).
- Type of wrap if used: gauze covered by adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

OBSERVATION TIME POINTS
- 24 and 72h.

SCORING SYSTEM:
- Draize test criteria.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- The test item is not a primary dermal irritant to rabbits under the conditions of this test.
- Combined Averages = 0.0.
- Primary Irritation Index = 0.0.

Any other information on results incl. tables

Table 1. Dermal Irritation scores.

Rabbit

Skin

E (24h)

Ed (24h)

E (72h)

E (72h)

Total Score

1

NA

0

0

0

0

0

A

0

0

0

0

0

2

NA

0

0

0

0

0

A

0

0

0

0

0

3

NA

0

0

0

0

0

A

0

0

0

0

0

4

NA

0

0

0

0

0

A

0

0

0

0

0

5

NA

0

0

0

0

0

A

0

0

0

0

0

6

NA

0

0

0

0

0

A

0

0

0

0

0

Avg

NA

0

0

0

0

0

A

0

0

0

0

0

E/Ed: Erythema and Edema, NA: non-abraded skin, A: abraded skin.

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
EU criteria.
Conclusions:
Under test conditions, the test substance was found to be non-irritating.
Executive summary:

A study was performed on the test item to investigate its possible irritation or corrosion on rabbits, according to the method of Draize (1944), similar to OECD Guideline 404 (no GLP). Six New Zealand White rabbits (3 males, 3 females) were applied 0.5 ml of test item on 2"x2" clipped (intact) or abraded areas of skin, covered with occlusive dressing during 24h. Then, the wrapping and the test item were removed, and the sites were individually examined and scored for erythema and edema at 24 and 72h. The mean values were used to determine the final irritation indices. Under test conditions, the test item was found to be non-irritating to the skin (irritation score = 0.0).