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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1997-08-27 to 1997-08-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Version / remarks:
September 27, 1985
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
430-710-1
EC Name:
-
Cas Number:
15290-77-4
Molecular formula:
C5H3F7
IUPAC Name:
1,1,2,2,3,3,4-heptafluorocyclopentane
Specific details on test material used for the study:
Batch No.: 9705-2A
Purity:> 97%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: 13 to 24 weeks
- Weight at study initiation: 3.0 to 4.4 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) SQC Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 49-71
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
liquid substance administered as supplied
Controls:
no
Amount / concentration applied:
0.5 mL to each site.
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 25 mm x 25 mm
- Coverage: covered with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30 to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal reactions were observed in any animal throughout the study
Other effects:
CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Dermal reactions individual scores:

No.

Erythema

Oedema

24h

48h

72 h

24h

48h

72 h

2313

0

0

0

0

0

0

2314

0

0

0

0

0

0

2315

0

0

0

0

0

0

2316

0

0

0

0

0

0

2317

0

0

0

0

0

0

2318

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.
Executive summary:

A study was performed to assess the skin irritation potential of test item to the rabbit following EPA OTS 798.4470. Six rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for four days.

There were no signs of toxicity or ill health in any rabbit during the observation period.

No dermal reactions were observed in any animal throughout the study

A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.