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

Endpoint summary

Description of key information

An in vivo skin irritation and in vivo eye irritation study have been conducted with MV5CN. The results of the studies were:

Not a skin irritant when tested according to OECD 404.

Not an eye irritant when tested according to OECD 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

1998

Deviations:

no

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)

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

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:

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.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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°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.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING : None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data.
- Weight at study initiation: 3.4-3.9 kg
- Housing: in fully air conditioned rooms in separate cages arranged in a battery.
- 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: no data.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, and 72 hours after administration of the test substance. At 24 and 72 hours th eyes were further examined for corneal lesions under UV Light after instillation of one drop of a 0.01% fluorescein-sodium solution.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, washed out thoroughly with isotonic saline at 37 degrees C.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Lesions in cornea, iris or conjunctivae were graded numerically.

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: See 'Remarks'

Remarks:

Conjunctival redness resolved in this animal (score 0) at 72 hours.

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All scores were 0 for corneal opacity and iritis. There were redness scores of 1 at 48 hours for 1/3 animals. All other animals and time points were zero for redness. There was no discharge reported. Chemosis scores were zero for all animals at 1, 24, 48, and 72 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, MV5CN is not considered to be an eye irritant according to GHS.

Executive summary:

The objective of this study was to determine the potential of MV5CN ocular irritation/corrosion in a study according to OECD 405 in compliance with OECD GLP. Three female rabbits were used for this study. MV5CN (0.1 mL) was administered to the conjunctival sac of the left eye of each rabbit. The eyes were examined and scored at 1, 24, 48, and 72 hours after treatment. All scores were 0 for corneal opacity and iritis. There were redness scores of 1 at 48 hours for 1/3 animals. All other animals and time points were zero for redness. There was no discharge observed. Chemosis scores were zero for all animals at 1, 24, 48, and 72 hours. Based on the results of the study, MV5CN is not considered to be an eye irritant according to GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Based on the results of the studies, MV5CN is not a skin or eye irritant.