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Diss Factsheets

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:
1984-01 to 1984-04-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
animal room temperature slightly low (16°C); purity of the test material not reported.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid
EC Number:
614-283-9
Cas Number:
68127-59-3
Molecular formula:
C9H10ClF3O2
IUPAC Name:
reaction mass of (1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid and (1S,3S)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylic acid
Details on test material:
- Physical state: crystalline powder
- Colour: white
- Expiration date of the lot/batch: not reported
- Storage condition of test material: not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 3.43 - 3.75 kg
- Housing: individually in satinised aluminium sheet cages, 605 x 490 x 455 mm; floor: perforated aluminium sheet, door: Makrolon (polycarbonate)
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 16°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 500 mg, moistened to a paste with water
- Test site: approx. 25 x 25 mm on the left flank of the animal
- Application: by disposable spatula

VEHICLE
- Amount applied (volume or weight with unit): 0.5 mL
- Purity: distilled
Duration of treatment / exposure:
4 hours
Observation period:
1, 25, 45 and 69 hours after removal of dressing
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: 25 x 25 mm
- % coverage: not reported
- Type of wrap if used: a piece of surgical gauze (25 x 25 mm, 8-ply) covering the treated area was secured by two strips of surgical tape (12 x 100 mm), and covered with 0.5 mm rubber sheeting (350 x 135 mm), which was wrapped around the trunk and secured with adhesive polyethylene tape (450 x 75 mm).

REMOVAL OF TEST SUBSTANCE
- Washing: application site cleansed with swabs of absorbent cotton wool soaked in warm water, gently dried with tissue paper
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- Draize scale, as in OECD 404
- Mean erythema and edema scores were calculated as the average of the 25-, 45- and 69-hour readings of all six animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animal 7
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: animal 7
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
other: animal 8
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: animal 8
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
other: animal 23
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: animal 23
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
other: animal 24
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: animal 24
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
other: animal 46
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: animal 46
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
other: animal 47
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
other: animal 47
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Slightly irritant to rabbit skin, no corrosion observed . Erythema and edema reversible.
Other effects:
None observed

Any other information on results incl. tables

Table 1: Rabbit skin irritation

Erythema & edema: Draize scores for individual animals:

Erythema Edema

Animal no

 Hours after decontamination Hours after decontamination
1 25 45 69 1 25 45 69
7 1 0 0 0 2 0 0 0
8 1 0 0 0 3 0 0 0
23 1 1 0 0 2 0 0 0
24 1 0 0 0 1 0 0 0
46 1 0 0 0 3 1 0 0
47 2 1 0 0 1 1 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight erythema and slight edema was caused by the test material on rabbit skin, 25 hours after the treatment (mean score 0.11, both for erythema and edema). The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labelling.
Executive summary:

The acute skin irritation of the test material (a powder) was assessed according to a method similar to OECD 404 in six female New Zealand White rabbits. The test substance (0.5 g) was moistened with 0.5 mL deionized water and applied to the shaved skin (approx. 6 cm2), then covered with a gauze patch and semi-occlusive dressing for an exposure period of 4 hours. The application area was then cleansed with cotton wool swabs soaked in warm water, and dried with tissue paper. The degrees of erythema and edema were assessed at the following time points: 1, 25, 45, and 69 hours after the removal of the patch, according to the Draize scale. Mean erythema and edema scores were calculated from the readings at 25, 45, and 69 hours.

Very slight to well-defined erythema, and very slight to moderate edema were observed after 1 hour; these findings were still seen in only 2/6 animals at 25 hours, and completely disappeared at 45 hours. From the numerical scores of the individual animals at 25, 45, and 69 hours, the averages for erythema and edema were calculated to be 0.11 each.