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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The test substance was applied under occlusive conditions.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2- phenoxyethanol (technical grade)
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: substance number: 83/143
- Expiration date of the lot/batch: May 1984

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; Offenbach, Germany
- Weight at study initiation: 2.79 kg, 2.32 kg, 3.00 kg
- Housing: single in stainless-steel cages
- Diet (e.g. ad libitum): Ovator Solikanin 4mm, Muskator-Werke Düsseldorf
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
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): ca. 0.5 mL
- Concentration (if solution):
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (two males and one female)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk (2.5 x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol/water (1:1) and water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 min
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 min as well as 24, 48 and 72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified