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Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 16 until February 23, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,​1'-​Biphenyl, 4-​(trans-​4-​ethylcyclohexyl)​-​2,​3',​4',​5'-​tetrafluoro-
EC Number:
605-735-6
Cas Number:
174805-87-9
Molecular formula:
C20 H20 F4
IUPAC Name:
1,​1'-​Biphenyl, 4-​(trans-​4-​ethylcyclohexyl)​-​2,​3',​4',​5'-​tetrafluoro-
Test material form:
solid
Specific details on test material used for the study:
Batch: AR 001/95
Consistency: Crystals
Released until: Jan 13, 1997


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test material was moistened with liquid paraffin.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 19-20 weeks
- Weight at study initiation:3.14 (2.90 - 3.46) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 32 - 40%


IN-LIFE DATES: From: day 1 To: day 8

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Liquid paraffin
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g per animal

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 (2 male & 1 females)
Details on study design:
TEST SITE
- Area of exposure: left side of the animal back (Test item), right side of the animal back (Carrier)
- Type of wrap if used: polyethylene foil, which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 8

SCORING SYSTEM:
Evaluation of skin reactions according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
Under the given experimental conditions erythema (score 1) in the treated areas were observed in two of the three animals from day 1 until 3 of the study.

The cumulative mean scores for erythema were:
Day 1: 0.0 (1 hour)
Day 2: 0.7 (24 hours)
Day 3: 0.7 (48 hours)
Day 4: 0.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Any other information on results incl. tables

Study design

To test for primary skin irritation, 0.5g of the test material was mixed with some drops of liquid paraffin to ensure good contact to the skin. Afterwards, the test material was spread onto 4 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under occlusive conditions.

The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for further 7 days.

Results

Under the given experimental conditions erythema (score 1) in the treated areas were observed in two of the three animals from day 1 until 3 of the study.

The cumulative mean scores for erythema were:

Day 1: 0.0 (1 hour)

Day 2: 0.7 (24 hours)

Day 3: 0.7 (48 hours)

Day 4: 0.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Conclusions

According to the results of the study, for regulatory purposes there is no need for classification (all mean scores are below 2,3).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of the study, for regulatory purposes there is no need for classification (all mean scores are below 2,3).
Executive summary:

This study was performed according to GLP and methods applied are fully compliant with OECD TG 404.

According to the results of the study, for regulatory purposes there is no need for classification (all mean scores are below 2,3).

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