Perfluoroethane

Endpoint summary

Description of key information

Oral: In accordance to REACH Annex XI Section 2; information requirement section 8.5.1, guideline testing for acute oral toxicity is technically not feasible because the test substance is a gas.
Dermal: In accordance to REACH Annex XI Section 2; information requirement section 8.5.3, guideline testing for acute dermal toxicity is technically not feasible because the test substance is a gas.
Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was > 500000 ppm (2822327 mg/m3).  Reliability = 1.

Key value for chemical safety assessment

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect dated 1998.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect dated 2008.

Qualifier:

according to guideline

Guideline:

other: MAFF Japan Agricultural Chemicals Regulation Laws 2-1-3 Notification 12-Nousan-8147 and Notification 13 Seisan 1739 (2000 and 2001)

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

no

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 319.2-368.2 g (males); 213.0-232.9 g (females)
- Fasting period before study: no data
- Housing: individually in solid bottom caging with bedding and nestlets as enrichment
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26ºC (68-79ºF)
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): approximate 12-hour light/dark cycle

Route of administration:

inhalation: gas

Type of inhalation exposure:

whole body

Vehicle:

other: air and oxygen

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical glass chamber with a glass baffle inside to promote uniform distribution of the test atmosphere
- Exposure chamber volume: 19 L
- Method of holding animals in test chamber: stainless steel, wire-mesh modules (sexes separate)
- Source and rate of air: houseline compressed air and oxygen; metered into 1-liter 3-neck mixing flasks by Brooks mass flow controllers (MFC); 10 L/minute
- Method of conditioning air: vapour and air mixture left the mixing flasks and entered a glass transfer tube where supplemental chamber oxygen was added to the mixture using a Brooks MFC
- Treatment of exhaust air: exhausted through a dry-ice cold trap and an MSA filter cartridge prior to discharge into the fume hood
- Temperature, humidity, pressure in air chamber: 20-24°C; 30-70%; no data

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography 16 times during the 4-hour exposure; Chamber atmosphere was continually drawn from the exposure chamber and directly injected into a gas chromatograph (GC) equipped with a pneumatically operated gas sample valve and a flame ionization detector
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

500000 ± 9700 ppm

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: daily for first 7 days after exposure then once on Day 14
- Frequency of weighing: daily for first 7 days after exposure then once on Day 14
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 500 000 ppm

Based on:

test mat.

Exp. duration:

4 h

Mortality:

None

Clinical signs:

other: None

Body weight:

Three male rats displayed weight losses ranging from 3.4 to 12 grams on the day after the exposure. There were no other body weight losses in male rats throughout the recovery period. Four of 5 female rats displayed weight losses ranging from 0.1 to 19.4 grams on the day following the exposure, and one female rat continued to lose weight (3.8 grams) on post-exposure day 2. This same female rat gained 5.4 grams on post-exposure day 3 but then lost 8.7 grams on post-exposure day 4. There were no other body weight losses observed in female rats throughout the remainder of the recovery period.

Gross pathology:

Gross discoloration of the lungs was present in one male rat, was nonspecific, and is a common finding in rats of this strain and age. No other gross lesions were observed.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LC50 > 500000 ppm.

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).

Executive summary:

One group of 5 male and 5 female Crl:CD(SD) rats was exposed whole-body to test substance vapours in air. The test atmosphere was generated by dilution of the test substance vapour in air and oxygen. Chamber concentrations of the test substance were measured by gas chromatography. Rats were weighed and observed for clinical signs of toxicity during a 14-day recovery period. After the recovery period, the rats were sacrificed and examined for gross pathologic abnormalities. All animals survived the exposure and subsequent 14-day recovery period.

 

Rats were exposed for 4 hours to a mean concentration of 500000 ± 9700 ppm (mean ± standard deviation). The rats’ startle responses were normal throughout the 4-hour exposure. There were no clinical signs of toxicity observed during the exposure or the recovery period. Three male rats displayed weight losses ranging from 3.4 to 12 grams on the day after the exposure. There were no other body weight losses in male rats throughout the recovery period. Four of 5 female rats displayed weight losses ranging from 0.1 to 19.4 grams on the day following the exposure, and one female rat continued to lose weight (3.8 grams) on post-exposure day 2. This same female rat gained 5.4 grams on post-exposure day 3 but then lost 8.7 grams on post-exposure day 4. There were no other body weight losses observed in female rats throughout the remainder of the recovery period.

Gross discoloration of the lungs was present in one male rat, was nonspecific, and is a common finding in rats of this strain and age. No other gross lesions were observed.

 

Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for the test substance in male and female rats was greater than 500000 ppm.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

2 822 327 mg/m³ air

Additional information

In a rat 4-hour acute inhalation study, the LC50 was greater than 500000 ppm (2822327 mg/m3). All animals survived the exposure and subsequent 14-day recovery period. The rats’ startle responses were normal throughout the 4-hour exposure and there were no clinical signs of toxicity observed during the exposure or the recovery period. Body weight losses were observed up to four days post-exposure. No further body weight losses were observed throughout the remainder of the recovery period.

Justification for classification or non-classification

Based on the rat 4-hour LC₅₀ > 500000 ppm (2822327 mg/m³), the substance does not need to be classified for acute inhalation toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Data are lacking due to waiving arguments, so the substance cannot be classified for acute oral or dermal toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.