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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-6
Remarks on result:
not determinable because of methodological limitations
Remarks:
necrosis was observed
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.