2,2,3,3,3-pentafluoropropanol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 - 27 September 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

Adopted 12 May 1981

Deviations:

not specified

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,3,3,3-pentafluoropropanol

EC Number:

207-012-7

EC Name:

2,2,3,3,3-pentafluoropropanol

Cas Number:

422-05-9

Molecular formula:

C3H3F5O

IUPAC Name:

2,2,3,3,3-Pentafluoropropan-1-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: CD (SD)

Remarks:

Specific Pathogen Free

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japanese Charles River, Atsugi, Kanagawa Prefecture, Japan
- Age at study initiation: 6 weeks
- Weight at study initiation: 110 - 150 g (males) and 90 - 120 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: stainless steel cages with mesh flooring
- Diet: CRF-1 pelleted, not further specified, ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15 - 17
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 September 1989 To: 27 September 1989

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: pictured, stainless steel exposure chamber but not further specified. Whole-body of animals was exposed to the test article as a vapour.
- Exposure chamber volume: 0.52 m³
- Source and rate of air: indoor air
- Method of conditioning air: filtered
- System of generating particulates/aerosols: test material was evaporated by bubbling in a heated atmosphere. Through two heat exchangers and flowmeter of the particles, the concentration of the test material was regulated.
- Treatment of exhaust air: charcoal filter
- Temperature, humidity, pressure in air chamber: 23 ± 2°C, 30 - 70%, between 0 and -15 mm Aq

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography every 15 minutes
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

GC

Duration of exposure:

ca. 4 h

Concentrations:

3170, 3480, 3830, 4210, 4640, and 5100 ppm (males and females, nominal concentration)
3102.7 ± 15.6, 3475.4 ± 45.5, 3826.2 ± 28.4, 4223.6 ± 28.6, 4686.5 ± 159.4, and 5208.6 ± 145.4 ppm, respectively (analyzed concentrations)
19.04 ± 0.1, 21.33 ± 0.3, 23.48 ± 0.2, 25.92 ± 0.2, 28.77 ± 1.0, and 31.96 ± 0.9 mg/L, respectively (analyzed concentrations [in ppm] converted to vapour exposure units of mg/L)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed from 1-2, 3-4, and 5-6 hours post-administration on Day 0, then daily for 14 days. Individual body weights were taken on Days 0 (pre-administration), 1, 3, 7, 10, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology.

Statistics:

Male and female LC50s were calculated based on the Bliss method.
Body weight means ± SD in all Dosed Groups were calculated.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 24.43 mg/L air (analytical)

Based on:

test mat.

Remarks:

corresponding to 3982.0 ppm

95% CL:

ca. 3 837 - ca. 4 135

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 23.45 mg/L air (analytical)

Based on:

test mat.

Remarks:

corresponding to 3823.0 ppm

95% CL:

ca. 3 668 - ca. 3 977

Exp. duration:

4 h

Mortality:

3170 ppm (19.45 mg/L): 0/10 males
3480 ppm (21.35 mg/L): 0/10 males
3830 ppm (23.50 mg/L): 2/10 males, by the end of Day 0
4210 ppm (25.83 mg/L): 9/10 males, by the end of Day 0
4640 ppm (28.47 mg/L): 10/10 males, by the end of Day 0
5100 ppm (31.30 mg/L): 10/10 males, by the end of Day 0

3170 ppm (19.45 mg/L): 0/10 females
3480 ppm (21.35 mg/L): 1/10 females, by the end of Day 1
3830 ppm (23.50 mg/L): 4/10 females, by the end of Day 0
4210 ppm (25.83 mg/L): 10/10 females, by the end of Day 0
4640 ppm (28.47 mg/L): 10/10 females, by the end of Day 0
5100 ppm (31.30 mg/L): 10/10 females, by the end of Day 0

Clinical signs:

other: In the observation of general symptoms: decline in self-mobility, prone or lying postures, loss of aural reflex, and abnormal breathing (slow breathing) were found with the males and females in each group during the exposure. Additionally after the exposu

Body weight:

Body weights in all dosed groups were reduced per group compared to the group pre-administration weights, but increased steadily afterwards.

Gross pathology:

Reddened lungs, red spots in the lungs, and red spots in the thymuses were noted for some of the found dead males and females. Mild lenticular opacity was noted in some surviving animals except those females in the 3170 ppm (lowest concentration) dosed group.

Any other information on results incl. tables

 Acute Inhalation Toxicity

Dose		Mortality	Clinical Signs
[ppm]	[mg/L]^a	N^b	N^b
Males
3170	19.45	0/10	10/10
3480	21.35	0/10	10/10
3830	23.50	2/10	10/10
4210	25.83	9/10	10/10
4640	28.47	10/10	10/10
5100	31.30	10/10	10/10
Females
3170	19.45	0/10	10/10
3480	21.35	1/10	10/10
3830	23.50	4/10	10/10
4210	25.83	10/10	10/10
4640	28.47	10/10	10/10
5100	31.30	10/10	10/10

^aConverted to vapour exposure units

^bNumber of animals dosed

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

Based on a single exposure and mortality for 14 days, LC50 values were calculated using the Bliss method.
Male: LC50 3982 ppm (95% confidence limit: 3837-4135 ppm)
Female: LC50 3823 ppm (95% confidence limit: 3668-3977 ppm)
However, to categorize the exposure scenario based on a vapour phase exposure, the units of ppm must be converted to units of mg/L. To do this, use the following formula: (ppm) x (MW of 150.05)/ 24.4529 which yields an exposure in mg/m³, which can then be converted to units of mg/L by dividing (m³) by 1000.
Male: LC50 24.43 mg/L (95% confidence limit: 23.5-25.4 mg/L) for vapour
Female: LC50 23.45 mg/L (95% confidence limit: 22.5-24.4 mg/L) for vapour
The acute toxicity estimate values for these LC50s (vapour form) of the test material, classify it in Category 5 (>20.0 mg/L = Category 5).