2,2,3,3,3-pentafluoropropanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

02 - 12 September 1989

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize Test Guidelines

Version / remarks:

Draize Testing method (Draize JH et al., Pharm. Exp. Ther. 82: 377-390, 1944; Draize JH, Assoc. Food Drugs Officials of the United States: 46-49, Topeka Kansas, 1965) as prescribed by the FDA (in The Federal Register 38 No. 187 §15000.41, USA).

Deviations:

yes

Remarks:

concentration of test substance was not mentioned

Principles of method if other than guideline:

- Principle of test: the principles of the Draize primary skin irritation test in rabbits were followed
- Short description of test conditions: the skin on the backs of rabbits is shaved with four quadrants being assigned per rabbit: 2 abraded and 2 intact sites. Two test substances were applied per rabbit yielding one abraded and one intact site per rabbit per test substance. A volume of 0.5 mL of each test substance was applied to each site. After 24 hours of unoccluded exposure, all test sites were gently washed with distilled water, and graded for erythema and edema at 1 and 48 hours after washing.
- Parameters analysed / observed: Clinical observations were made on the day of administration, and daily thereafter. Erythema and edema were graded according to the Draize scales. A Primary Irritation Index was generated by averaging of the sums of the 1 and 48 hour grades for erythema and edema per test substance.

GLP compliance:

not specified

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:

rabbit

Strain:

other: White Japanese

Remarks:

JW-NIBS / Rabiton

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rabiton Institute, Inc., Japan
- Age at study initiation: 3.5 - 4 months
- Weight at study initiation: 2.00 - 2.37 kg
- Housing: metal cages
- Diet: NRT-1s from Nisseiken, Tokyo, Japan, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 40 - 60%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02 September 1989 To: 12 September 1989

Test system

Type of coverage:

open

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted, not further specified

Duration of treatment / exposure:

24 h

Observation period:

3 days, not further specified
Reading time points: 1 h and 48 h corresponding to 24 and 72 hour reading time points according to current guideline

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: not specified
- Type of wrap if used: sponge and surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with distilled water
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
- 1 (after the 24 h exposure) and 48 h after washing

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 unabraded sites

Time point:

other: 24/72

Score:

ca. 1.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: No data after 72 h scoring

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 unabraded sites

Time point:

other: 24/72

Score:

ca. 0.58

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: No data after 72 h scoring

Irritant / corrosive response data:

The Primary Irritation Index (PII) was calculated based on Draize scoring. The test material is considered a moderate skin irritant based on the PII.

PII scores of < 2 are slightly irritating, scores of 2 - 6 are moderately irritating, and scores of > 6 are strongly irritating.

Mean of the Intact erythema plus edema 24 h scores: 2.50
Mean of the Abraded erythema plus edema 24 h scores: 4.17
Mean of the Intact erythema plus edema 48 h scores: 1.67
Mean of the Abraded erythema plus edema 48 h scores: 2.50

Primary Irritation Index (PII) = Average of these 4 Means: 2.71

Other effects:

- Other adverse local effects: On abraded sites necrosis was observed, not further specified
- Other adverse systemic effects: Throughout the test period, no other abnormalities were noted in any animals

Any other information on results incl. tables

Table 1. Intact Skin Reported Only

Reading Time Point	Rabbit No.
	1		2		3		4		5		6
	Ery	Oed	Ery	Oed	Ery	Oed	Ery	Oed	Ery	Oed	Ery	Oed
No experimental data available for the 24 h time reading; however for calculation of mean (x̅) scores, the reported 1 h values were used as 24 h, since the time reading was 1 h after the 24 h exposure.
24 h	2	2	3	2	1	0	1	0	2	1	1	0
72 h	3	1	2	1	0	0	0	0	3	0	0	0
x̅ of 24 +72 h	2.5	1.5	2.5	1.5	0.5	0	0.5	0	2.5	0.5	0.5	0

Ery = Erythema

Oed = Oedema

Table 2. Abraded Skin Reported Only

Reading Time Point	Rabbit No.
	1		2		3		4		5		6
	Ery	Oed	Ery	Oed	Ery	Oed	Ery	Oed	Ery	Oed	Ery	Oed
No experimental data available for the 24 h time reading; however for calculation of mean (x̅) scores, the reported 1 h values were used as 24 h, since the time reading was 1 h after the 24 h exposure.
24 h	4	2	4	2	2	0	2	1	4	1	2	1
72 h	4	1	2	1	0	0	1	0	4	0	1	1
x̅ of 24 +72 h	2.5	1.5	2.5	1.5	0.5	0	0.5	0	2.5	0.5	0.5	0

Ery = Erythema

Oed = Oedema

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

This study was not performed according to current OECD guideline 404 as the treatment lasted 24 hours and skin irritation scores were evaluated after 1 hour and 48 hours after removing the test substance. Skin irritation was observed in all 6 animals. In 3 of 6 animals the skin irritation was not reversible. Thus, a final conclusion on the skin irritation potential of the test substance cannot be made.