3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 June 2001 To 3 July 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP guideline study without deviation.

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 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

EC Number:

217-288-0

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Cas Number:

1800-91-5

Molecular formula:

C10H6F12

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Constituent 2

Reference substance name:

1,6 Divinylperfluorohexane

IUPAC Name:

1,6 Divinylperfluorohexane

Test material form:

other: Liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

AlpK:APfSD (Wistar-derived)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rodent Breeding Unit, Alderley Park, Macclesfield, Cheshire, UK.
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 335 - 357 g +/-9.1 (males); 239-255 g +/- 6.1 (females)
- Housing: 5 per cage per sexe
- Diet (e.g. ): Diet (RM1), supplied by Special Diet Services Limited, Witham, Essex, UK, ad libitum
- Water (e.g. ad libitum): mains water, supplied by an automatic system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 (see also inhalation exposure below for the exposure period)
- Humidity (%): 30 -70 (see also inhalation exposure below for the exposure period)
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12h/ 12h

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The rats were exposed nose-only to the test atmospheres. Animals were restrained in polycarbonate tubes supplied by Battelle, Geneva, Switzerland. These were inserted into a PERSPEX exposure chamber. The chamber was covered with an aluminium cone and stood on an aluminium base.
- Exposure chamber volume: The chamber consisted of sections of PERSPEX tubing (6 mm wall thickness) with an internal diameter of 28 cm and height of 15 cm (approximate volume 9.2 litres).
- System of generating vapour: The test atmosphere was generated using a heated, jacketed glass condenser. The test substance was pumped to the condenser using a Watson Marlow peristaltic pump. A counter current of clean, dry air (dried and filtered using equipment supplied by Atlas-Copco, Sweden) was passed at a nominal flow rate of 20l/minute (at normal temperature and pressure) through the condenser and carried the atmosphere to the exposure chamber (internal volume of 27.6 litres), in order to achieve a minimun of 12 air changes per hour. Since diluting air was not employed, the flow rates through the exposure chambers were the same as that employed in the generation of the test atmosphere. Air flows were monitored continuously and recorded at least 3 times using variable area flowmeters (KDG Flowmeters, Burgess Hill, Sussex, UK)
- Temperature, humidity, pressure in air chamber: The temperature and relative humidity in each chamber were recorded at least 3 times during exposure using a portable, digital temperature and relative humidity monitor; they were within the range of 20.4-21.2 °C and 15-20 % respectively.

TEST ATMOSPHERE
- Brief description of analytical method used: Samples were analysed using gas chromatography.
- Samples taken from breathing zone: yes. Test atmospheres were sampled from a front-facing port of the relevant exposure chamber, using a 5 ml gas-tight syringe equipped with an integral on-off valve and detachable sampling probe.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Target concentration: 1800 ppm (correspond to 26.07 mg/l; MW=354.1355 g/mol) = maximum stable vapour concentration achievable, as determined in a trial generation.
Achieved concentration: 1761 ppm (correspond to 25.5 mg/l; MW= 354.1355 g/mol)

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Prior to the start of the study, all rats were examined to ensure that they were physically normal and exhibited normal activity. During exposure, they were observed frequently. At the end of the 4-hour exposure period, each rat was given a detailed clinical examination. The animals were also given detailed clinical observations, (including the finding of "no abnormalities detected') daily during the 14 day observation period.
- Necropsy of survivors performed: yes, all animals were given a gross examination post mortem. This involved an external observation and an internal examination of all thoracic and abdominal viscera.
- Other examinations performed: clinical signs, body weight (d-1, d1, d8, d15)

Statistics:

No statistics were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 761 ppm

Based on:

test mat.

Remarks:

(vapours)

Exp. duration:

4 h

Remarks on result:

other: correspond to 25.5 mg/l (maximum stable vapour concentration achievable)

Mortality:

There were no deaths in animals exposed to 1761 ppm during the exposure or observation periods.

Clinical signs:

other: Observations during exposure: Abnormalities generally associated with restraint (wet fur and chromodacryorrhoea) were seen in some animals exposed to 1761 ppm. All animals had stains around the snout. Observations immediately after exposure: All animals h

Body weight:

All animals had gained weight by day 8 of the study and this trend continued until day 15.

Gross pathology:

There were no macroscopic changes seen post mortem.

Other findings:

None. There was no evidence of respiratory irritation or toxicity.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

CLP criteria

Conclusions:

Under the experimental conditions of this test, no deaths occurred at a vapour concentration of 1761 ppm (25.5 mg/l; maximum stable vapour concentration achievable) and there was no evidence of respiratory irritation or toxicity.

Executive summary:

One group of five male and five female Alpk:APfSD (Wistar-derived) rats were exposed nose-only for a single four-hour period to a vapour of dodecafluoro, deca-1,9 -diene at a target concentration of 1800 ppm (which was the maximum stable vapour concentration achievable). Test atmospheres were analysed to determine the vapour concentration of the test substance. Following exposure, the animals were retained without treatment for 14 days. Clinical observations and bodyweights were recorded throughout the study and at the end of the scheduled period, the animals were killed and given a gross examination post mortem. At an exposure concentration of 1761 ppm all animals had gained weight by day 8 and the trend continued throughout the study. There were no clinical changes indicative of toxicity, no macroscopic changes and no deaths. Nose-only exposure for 4 hours to Dodecafluoro, deca-1,9-diene at a vapour concentration of 1761 ppm caused no deaths. Under the test conditions, the acute inhalation LC50 of test material in rats was determined to be higher than 1761 ppm (correspond to 25.5 mg/l, vapours), thus the test substance does not require classification according to CLP Regulation (EC 1272/2008).