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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:
04 March 2002 to 29 April 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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 (incl. certificate)
Remarks:
FREIE UND HANSESTADT HAMBURG; BEHÖRDE FÜR ARBEIT, GESUNDHEIT UND SOZIALES, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: 3.5-4 months
- Weight at study initiation: 1.9-2.0 kg
- Housing: Individually in cages measuring 425x600x380 mm
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany; analysed for contaminants at least twice a year), ad libitum
- Water: tap water (analysed for contaminants at least twice a year), ad libitum
- Acclimation period: At least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 09 April 2002 to 29 April 2002

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
96 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: At any time point the erythema score was 1.
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Animals 1 and 2 showed no signs of irritation at any time point. Animal 3 had an erythema (grade 1) from 60 minutes up to 72 hours after patch removal.
Other effects:
There were no other effects reported.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested for skin irritation/corrosion according to the OECD TG 404 and in complinance with GLP. Minor erythema (score 1) was observed in one out of three animals, which was reversible within 96 hours. Hence, the test item was found to be not irritating and classification according to 67/584/EEC and EC/1272/2008 is not warranted.