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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

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: refrigerator (approx. 2-8C), 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
- Treatment of test material prior to testing (e.g. warming, grinding): Not applicable
- Preliminary purification step (if any): No data
- Final concentration of a dissolved solid, stock liquid or gel: No data
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): Not applicable

FORM AS APPLIED IN THE TEST (if different from that of starting material) : unchanged test substance

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) : not applicable
- Source: Harlon Winkelmann GmbH, Gartenstrasse 27, D33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable) : No data
- Age at study initiation: 6-10 weeks
- Weight at study initiation: males: mean 239 g; females: mean 193 g
- Fasting period before study: No data
- Housing: 3 animals per cage
- Historical data: kept by lab
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known : No data
- Method of randomisation in assigning animals to test and control groups: computer generated algorithm

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22C
- Humidity (%): 50%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

IN-LIFE DATES: From: 15 May 2001 To: 30 May 2001

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No vehicle
- Amount of vehicle (if gavage): No vehicle
- Justification for choice of vehicle: No vehicle
- Lot/batch no. (if required): No vehicle
- Purity: No vehicle

MAXIMUM DOSE VOLUME APPLIED:No data

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were recorded twice per day and body weights recorded weekly
- Necropsy of survivors performed: yes
- Clinical signs including body weight: Clinical observations were recorded twice per day and body weights recorded weekly
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Immediately after administration the male and female animals showed flanks drawn in and irregular respiration. In addition, panting was observed in one female animal. All clinical signs had completely disappeared 2 to 4 hours after adminstration in males

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of perfluorohexane nitrile vinyl ether for male and female rats is greater than 2000 mg/kg bw.

Executive summary:

MV5CN was assessed for acute toxicity in a GLP-compliant, OECD 423 study. Rats (3/sex) were administered the test substance via oral gavage at 2000 mg/kg bw. The animals were observed for 14 days post dose and clinical signs (twice daily) and body weights (weekly) were recorded. No mortality occurred. No changes to body weight or macroscopic changes were observed. Immediately after administration all animals showed flanks drawn in and irregular respiration. In addition, panting was observed in one female animal. All clinical signs had completely disappeared 2 to 4 hours after adminstration in males or 4 to 8 hours after administration in females. The LD50 of MV5CN rats is greater than 2000 mg/kg bw.