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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:
1982-11-09 to 1982-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: average: 2.5 kg
- Housing: individually in cages
- Diet (e.g. ad libitum): diet “mümmel z" (ssniff / Soest); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
test item moistened with water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 hours
Observation period:
8 days, irritation scores were obtained 1, 24, 48, 72 hours and 8 days after treatment
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² (2.5 x 2.5 cm)
- Type of wrap if used: Surgical gauze covered with test item were fixed with band-aid (Leukoflex), covered with a surrounding of a thin sheet of cellulose and afterwards the whole trunk were wrapped with an elastique bandage (Eloflex).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or olive oil
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48, 72 hours and after 8 days

SCORING SYSTEM:
- Method of calculation: Draize (see Table 1 in box "Any other information on materials and methods incl. tables")

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
Erythema could not be assessed as the skin was stained by the test material
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed. The erythema score could not be determined due to test material related colouring of the skin. For individual results please refer to Table 2 in box "Any other information on results incl. tables".
Other effects:
No skin irritation/erythema observed under the staining layer on the skin.

Any other information on results incl. tables

Table 2: Individual Skin Irritation Scores

24 hours 48 hours 72 hours Mean
Animal no. Erythema Edema Erythema Edema Erythema Edema Erythema Edema
1 * 0 * 0 * 0 - 0
2 * 0 * 0 * 0 - 0
3 * 0 * 0 * 0 -

0

* not determinable due to substance-induced staining of skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this acute dermal irritation/corrosion study, conducted according to OECD 404, the test item can be considered as non-irritating to the skin.
Executive summary:

In a primary dermal irritation study (OECD 404), three New Zealand White rabbits were dermally exposed to 0.5 g of the test item for 4 hours to an area of exposure of 2.5 x 2.5 cm under semi-occlusive conditions. Animals then were observed for 8 days. Irritation was scored by the method of Draize. No signs of irritation have been recorded at any of the observation points (1, 24, 48 and 72 h and 8 days). Based on the results, the test item can be considered as not dermal irritating.