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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:
April/May 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
but parallel running acute oral study was conducted under GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Yellow 160

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2 - 3 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Water: deionized (ad libitum)
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 To: 15. April 1983

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Remarks:
pasted with 0.35 mL
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after removal of the adhesive dressing
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 25 cm²
- % coverage:
- Type of wrap if used: gauze and semi-occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): -
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
30 to 60 min, 24, 48, 72 hours after removal of the adhesive dressing

SCORING SYSTEM: Draize
- Method of calculation: mean of 24, 48, 72 hour observations for each animal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema 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 was sloght reddening in two animals 30 to 60 min after test substance removal

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was determined to be not irritating to rabbit skin.
Executive summary:

A study was conducted to determine the in vivo skin irritation potential of the test substance according OECD Guideline 404 and EU Method B.4. Three rabbits (New-Zealand White) were exposed to 500 mg of the test substance for 4 h. The type of coverage was semi-occlusive, realised on shaved dorsal skin. The observation period was 72 h post-exposure. No erythema, edema or eschar formation was noted in any of the animals. Under the study conditions, the test substance was determined to be not irritating to rabbit skin.