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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (lack of data on test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of data on test substance
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP Inc., Denver, PA, USA
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: animals were housed separately in suspended stainless steel and wire mesh cages with absorbent paper below the cages.
- Diet: certified Rabbit Diet 5322 (PMI Feeds Inc., Richmond, IN, USA), the amount of feed was limited on a not further specified daily basis
- Water: tap water, ad libitum
- Acclimation period: 8 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 22 Aug 1995
To: 25 Aug 1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: ca. 6.5 cm² on the dorsal area from the shoulder to the lumbar region
- Type of wrap if used: the treated skin was covered with a non-irritating tape, held in place with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was wiped with paper towels and water.
- Time after start of exposure: 4h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritant / corrosive response data:
The dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.
Other effects:
Clinical signs were not observed in any animal during the study period. At the 72 h reading, two animals were observed with desquamation.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.