2,2,3,3,3-pentafluoropropanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-26 September 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-26 September 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given (comparable to guidelines/standards)

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline required

Principles of method if other than guideline:

Visual observation of the test item

GLP compliance:

no

Physical state at 20°C and 1013 hPa:

liquid

Form:

liquid

Remarks:

clear

Colour:

colourless

Substance type:

organic

Based on test material information, the substance is a colourless clear liquid.

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 401 (Acute Oral Toxicity)

Version / remarks:

Adopted 24 February 1987

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute 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: filtered, UV sterilzated 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: 12 September 1989 To: 26 September 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: due to the lack of water solubility, olive oil was selected as a vehicle.

MAXIMUM DOSE VOLUME APPLIED:
body weight/100 x 1

Doses:

1444, 1704, 2011, 2373 and 2800 mg/kg bw (males)
1229, 1536, 1920, 2400 and 3000 mg/kg bw (females)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

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

Statistics:

Male and female LD50s were calculated based on the Bliss method.
Body weight changes in the Dosed Groups were calculated by t-test versus the Control Group body weights.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 948 mg/kg bw

Based on:

test mat.

95% CL:

ca. 1 801 - ca. 2 105

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 826 mg/kg bw

Based on:

test mat.

95% CL:

ca. 1 646 - ca. 2 019

Mortality:

Control (0 mg/kg bw): 0/10 males
1444 mg/kg bw: 0/10 males
1704 mg/kg bw: 2/10 males, by end of Day 1
2011 mg/kg bw: 6/10 males, by end of Day 1
2372 mg/kg bw: 9/10 males, by Day 3
2800 mg/kg bw: 10/10 males, by end of Day 1

Control (0 mg/kg bw): 0/10 females
1229 mg/kg bw: 0/10 females
1536 mg/kg bw: 3/10 females, by Day 3
1920 mg/kg bw: 4/10 females, by the end of Day 1
2400 mg/kg bw: 10/10 females, by the end of Day 1
3000 mg/kg bw: 10/10 females, by the end of Day 1

Clinical signs:

In the observation of general symptoms: decline in self-mobility, ataxic gait, loss of aural, tactile, and righting reflexes, abnormal breathing, and prone and recumbent postures were observed immediately after administration of doses in cases of mortality. In addition, some cases where death occurred showed lacrimation, overturning, contamination, epistaxis discharge, and decreased body temperature, followed by death. When animals were found dead, lacrimation and epistaxis discharge were noted in some cases.
In the cases of survival: decline in self-mobility, ataxic gait, abnormal breathing, and hunched position were observed after administration of doses. In some cases of survival, overturning and contamination were observed, but all cases were resolved by Day 2.

Body weight:

males
1444 mg/kg bw: significantly decreased (t-test; p ≤ 0.01) compared to control group
1704 mg/kg bw: significantly decreased (t-test; p ≤ 0.05) compared to control group
2011 mg/kg bw: significantly decreased (t-test; p ≤ 0.01) compared to control group
2372 mg/kg bw: significantly decreased (t-test; p ≤ 0.01) compared to control group
females
1229 mg/kg bw: decreased compared to control group
1536 mg/kg bw: significantly decreased (t-test; p ≤ 0.05) compared to control group
1920 mg/kg bw: significantly decreased (t-test; p ≤ 0.05) compared to control group

Gross pathology:

Red lungs or lungs with red spots/macules, and thymus glands with red spots/macules were found for the male and females, in many found dead rats. Red fluid accumulation in the nasal cavity, nose contamination, lung subinvolution, and brown urine accumulation in bladder were found in some of the found dead rats. Periodic dissection cases showed lungs with red spots/macules for the males in some cases, in the dosed or control groups. There were no significant corresponding changes in the females in the dosed or control groups.

Any other information on results incl. tables

 Acute Oral Toxicity

Dose [mg/kg bw]	Mortality	Clinical Signs
	N^a	N^a
Males
1444	0/10	4/10
1704	2/10	9/10
2011	6/10	10/10
2372	9/10	10/10
2800	10/10	10/10
Females
1229	0/10	9/10
1536	3/10	10/10
1920	4/10	10/10
2400	10/10	10/10
3000	10/10	10/10

^aNumber of animals dosed

Applicant's summary and conclusion

Interpretation of results:

other: Category 4 based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)

Conclusions:

Based on a single oral dose of the test material and mortality for 14 days, the following LD50 values were calculated using the Bliss method.
Male: LD50 1948 mg/kg (95% confidence limit: 1801-2105 mg/kg)
Female: LD50 1826 mg/kg (95% confidence limit: 1646-2019 mg/kg)