1,1,1,3,3,3-hexafluoropropan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1967, no further information.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test:
Applied neat (undiluted) and diluted (50%) test substance, with or without washing of the exposed area, to the clipped dorsal skin of rabbits. Observations of the exposed skin site reactions were done for 14 days.
- Short description of test conditions:
The substance was applied undiluted and as a 50% diluted solution in distilled water, over 4-8 seconds, to the clipped dorsal skin of six male albino rabbits. Two sites of exposure each were used for four of the six rabbits, the two remaining rabbits had one exposure site each. The treated areas were either left unwashed, or washed for one minute with a steady stream of water 60, 30, 15, and 5 seconds after exposure. Rabbits were observed for 14 days and then sacrificed without necropsy.
- Parameters analysed / observed:
Presence and degree of erythema and edema associated with exposure to the test substance, skin irritation and necrosis, and skin colour changes as observed at each of the test sites.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3,3-hexafluoropropan-2-ol

EC Number:

213-059-4

EC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Cas Number:

920-66-1

Molecular formula:

C3H2F6O

IUPAC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: albino rabbit, not further specified

Details on test animals or test system and environmental conditions:

None specified

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

water

Remarks:

distilled water: test substance was diluted 50% in 3 out of the 10 skin exposures.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.2 mL (undiluted 100%) or 0.4 mL (diluted)
- Concentration (solution): 100% or 50% aqueous solution (diluted with distilled water)

Duration of treatment / exposure:

Treated areas were either left unwashed, or washed at 60, 30, 15, and 5 seconds after test substance exposure.

Observation period:

14 days

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: Dorsal skin
- % coverage: Unspecified
- Type of wrap if used: None

REMOVAL OF TEST SUBSTANCE
- Washing: The treated areas were either left unwashed, or washed for one minute with a steady stream of water
- Time after start of exposure: 60, 30, 15, and 5 seconds after exposure

OBSERVATION TIME POINTS
- Daily for 14 days

SCORING SYSTEM:
- Method of calculation: Unspecified: observations, only, reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1-6

Remarks on result:

not determinable because of methodological limitations

Remarks:

necrosis was observed

Results 2

Irritation parameter:

edema score

Basis:

animal: 1-6

Remarks on result:

not determinable because of methodological limitations

Remarks:

necrosis was observed

Irritant / corrosive response data:

erythema - on the day of treatment, erythema was moderate to strong in 5 out of 7 of the treatment sites receiving 100% test substance exposure.
edema - on the day of treatment, edema was moderate to strong in 5 out of 7 of the treatment sites receiving 100% test substance exposure, and continued unresolved through Day 14.
Only the exposure sites that were washed at 5 seconds post-treatment, along with all of the treatment sites receiving 50% diluted dosing solution exposure, had no observable skin irritation on Day 14.

Other effects:

- Other adverse local effects:
On the day of and the day following treatment, blanching of the exposed skin area with subsequent skin colour change to a purplish hue was noted in 5 of 7 treatment sites receiving100% test substance exposure.
Necrosis and non-reversible chemical burn damage (unresolved on Day 14) was noted in 6 of 7 treatment sites receiving 100% test substance exposure.

Any other information on results incl. tables

Test Results: HFIP (1,1,1,3,3,3 -Hexafluoropropan-2 -ol)

Rabbit #	dose (mL)	conc (%)	washed sec post	Observations: Treatment day	Observations: Day 1	Observations: Days 2 - 14
4475	0.2	100	Not	-erythema: mild to strong -edema -immediate skin blanching then purple skin hue	-erythema: moderate to strong -edema: mild -skin blanching	-edema: strong -necrosis: sloughing skin for 14 days
	0.4	50	Not	-erythema: very mild	-erythema: very mild	none
4476	0.2	100	Not	-erythema: mild -edema: moderate	-erythema: moderate to strong -edema: mild -skin blanching with purple hue	-edema: moderate -necrosis: sloughing skin for 14 days
	0.2	100	60	-erythema: strong -edema -necrosis	-erythema: moderate to strong -edema -necrotic depression	-necrosis: sloughing skin for 14 days
4477	0.2	100	60	-erythema: moderate to strong -edema: strong -immediate skin blanching then purple skin hue	no change	-edema: strong -necrosis: sloughing skin for 14 days
	0.4	50	60	-erythema: very mild	-erythema: very mild	none
4480	0.2	100	5	-erythema: mild -edema: moderate	-erythema: moderate -edema: very slight	-erythema: mild at Day 2 -scaly: through Day 13 -normal on Day 14
	0.4	50	5	none	none	none
4494	0.2	100	15	-erythema: mild to moderate -edema: strong -immediate skin blanching then purple skin hue	-erythema: mild -edema: slight -skin blanching, with purple hue	-edema: moderate -necrosis: sloughing skin for 14 days
4504	0.2	100	30	-erythema: moderate -edema: strong -immediate skin blanching then purple skin hue	-erythema: moderate -edema: slight -skin blanching with purple hue	-edema: moderate -necrosis: sloughing skin for 14 days

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS Category 1A (H314) according to Regulation (EC) No 1272/2008

Conclusions:

Although the in vivo data is old and per study reliability may be of reliability 3, there are 2 corroborating studies clearly showing long lasting unresolved skin damage, and an immediate corrosive effect on the skin upon exposure to the test substance. This study was conducted prior to publication (1981) of the OECD Test Guidelines requirements for Skin Irritation/ Corrosion studies. Using a weight-of-evidence approach, i.e., in conjunction with the supporting skin contact study, it is possible to give an overall reliability rating of 2 to this study. This data is sufficient evidence to cover the skin irritation / corrosion endpoint, and classify the test substance as Skin Corrosion: 1A.