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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:
Apr 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Acid Red 299

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: mean: 2.7 Kg
- Housing: individual cages
- Diet: standard diet "ssniff K" ad libitum
- Water: tab water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4h
Observation period:
max. 14d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flanks of the rabbits
- coverage: 2.5 x 2.5 cm
- Type of wrap if used: gauze fixated with bandage

REMOVAL OF TEST SUBSTANCE
- Washing: treated areas were washed with water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1h, 24h, 48h, 72h, 7d, 14d

SCORING SYSTEM: Draize grades

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

Any other information on results incl. tables

Animal No Endpoint  Observation time 
24h 48h 72h
I erythema 0 0 0
edema 0 0 0
II erythema 0 0 0
edema 0 0 0
III erythema 0 0 0
edema 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is determined as not irritating and non-corrosive to rabbit skin under the conditions of the test.