2,2,3,3,4,4,5,5,6,6-decafluoro-6-trifluorovinyloxyhexanenitrile

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2,3,3,4,4,5,5,6,6-decafluoro-6-trifluorovinyloxyhexanenitrile

EC Number:

443-050-2

EC Name:

2,2,3,3,4,4,5,5,6,6-decafluoro-6-trifluorovinyloxyhexanenitrile

Cas Number:

120903-40-4

Molecular formula:

C8F13NO

IUPAC Name:

2,2,3,3,4,4,5,5,6,6-decafluoro-6-[(1,2,2-trifluoroethenyl)oxy]hexanenitrile

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 3
- Purity, including information on contaminants, isomers, etc.: 93.8%


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Approximately 5 degrees C in a refrigerator, light protected, under nitrogen.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: no data.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: no data.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no data.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no data.

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution: 0.5 mL Perfluorohexane nitrile vinyl ether

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: no data.
- Weight at study initiation: 3.3 - 4.0 kg
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 1 week under study conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3° C
- Humidity (%): 50 ±20%
- Air changes (per hr): No data.
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE: none

NEGATIVE CONTROL: none
POSITIVE CONTROL: none

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 cm2
- % coverage: semiocclusive
- Type of wrap if used: surgical plaster (specifically produced by Beiresdorf Aktiengesellschaft.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 30-60 minutes; 24, 48, 72 hours.

SCORING SYSTEM:
- Method of calculation: Erythema, eschar formation and edema were evaluated numberically according to the score of DRAIZE.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Erythema and edema scores of 0 were recorded for all animals at all observation intervals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

MV5CN was not irritating in a GLP compliant, OECD 404 skin irritation study.

Executive summary:

The skin irritation potential of MV5CN was evaluated in rabbits. The study was conducted according to OECD 404 in compliance with OECD GLP. MV5CN was semiocclusively applied (0.5 mL) onto the skin of three female rabbits for 4 hours. Observations were made 30-60 minutes, 24, 48, and 72 hours after treatment. All scores were 0 for both erythema and edema for all three animals at all observation times. The PII is 0/8.0. MV5CN was not irritating in a GLP compliant, OECD 404 skin irritation study.