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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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
84/449/EWG, B.4; OECD 404
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Red 239

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca 3-5 months
- Weight at study initiation: 2.6-2.9 kg
- Housing: single
- Diet: Altromin 2123, 15 g daily
- Water (ad libitum): deionized, chlorinated water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14.10.1986 To: 17.10.1986

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Remarks:
0.3 mL/500 mg to form paste
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 cm²
- Type of wrap if used: semiocclusive

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

SCORING SYSTEM: Draize
30 - 60 minutes, 24, 48 and 72 hours after removal of the test substance

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not irritant to rabbit skin and has not to be classified.
Executive summary:

Three Rabbits were treated with 500 mg Reactiv Red 239 on the dorsal region of the trunk.

One hour after the removal of the plaster the skin of the animals revealed hardly perceptible to clearly outlined erythema. Very slight oedema was observed in two animals. 24 to 48 hours after the removal of the plaster the skin still
exhibited hardly perceptible erythema.

72 hours after the removal of the plaster, all of the animals were free from signs of irritation.

Based on this results Reactive Red 239 is not irritant to rabbit skin and has not to be classified.