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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:
31 October to 3 November 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Rot F-66813 FW

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.1 - 3.1 kg
- Housing: single
- Diet: Altromin 2123 maintenance diet ad libitum and approx. 15 g hay/day
- Water: deionized chlorinated water ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 31. Oct To: 03 Nov. 1989

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
500 mg pased with 0.4 mL of 0.9% physiological saline solution
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: semi-occlusive

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

About 24 hours prior dermal treatment the fur of three rabbits was removed from the dorsal part of the torso with an electric hair clipper over an area of approximately 25 cm2. Only animals with intact skin were used.

500 mg of Reaktiv-Rot F-66813 FW (pasted with 0.40 mL 0.9% NaCI-solution) was applied to each animal. The pasted test substance was spread over the whole surface of the 2.5 x 2.5 cm cellulose patch of a surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster strip was then fixed to the prepared skin and covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the end of the 4 hours exposure period remnants of the still remaining test substance were removed from the skin with lukewarm water.

The skin was examined 30 - 60 minutes and 24, 48 and 72 hours after removal of the plaster.

Erythema, eschar formation and edema were evaluated numerically. All other changes of the skin were recorded.


SCORING SYSTEM:
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exp.) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of skin irritations during the whole study period. However, large areas of the treated skin were red discolored during the whole course of the study.
Other effects:
Reddish discoloration at treated skin during entire observation time

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Reaktiv-Rot F-66813 FW is not irritating to the skin and not subject to labelling requirements
Executive summary:

Based on the results of the present rabbit primary dermal irritation study Reaktiv-Rot F-66813 FW is not irritating to the skin and not subject to labelling requirements according to the classification critera of the Directive 83/467/EEC and the Ordinance on Hazardous Substances.