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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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1930-2270 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1,24, 48, 72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: at least 6 cm²

SCORING SYSTEM:
<0.5: non-irritant
0.6 - 3.0: slightly irritant
3.1 - 5.0: irritant
5.1 - 8.0: severely irritant

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hrs
Score:
0.17
Max. score:
8
Reversibility:
no data
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present experiment FAT 46'014/F was found to be slightly irritating when applied to the rabbit skin.
Executive summary:

A key study was performed to determine the skin irritation potential of FAT 46'014/F with purity of 35.7 % on

rabbits skin. This test was conducted in GLP compliance. The test was carried out on both intact and abraded skin areals under semi-occlusive conditions. The calculated dermal irritation index was 0.17. Under the conditions, the test substance FAT 46'014/F was found to be slightly irritating when applied to the rabbit skin.