(S,S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane;reaction mass of: (R,R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

420-640-8

EC Name:

-

Cas Number:

138495-42-8

Molecular formula:

C5H2F10

IUPAC Name:

(3R,4R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane; (3S,4S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Details on test material:

-Purity: 97.6%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: 2734-3108 g
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 g rabbit chow daily, except for approximately 24 hours when in stocks
- Water (e.g. ad libitum): ad libitum, except for approximately 24 hours when in stocks
- Acclimation period: Approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of untreated skin were used for comparison.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hours

Observation period:

1, 24, 48, and 72 hours after test substance removal

Number of animals:

2 female and 1 male

Details on study design:

TEST SITE
- Area of exposure: Scapular to lumbar region of the back
- % coverage: Not reported
- Type of wrap if used: A 2-inch gauze square was placed over the test site. The patch was held in place with non-irritating tape. Rubber sheeting was then wrapped around the animals and secured with clips.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with Ivory® soap and warm water and gently wiped dry.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

No irritation was observed in any rabbit by 1 hour after patch removal. By 24 hours, 1 rabbit exhibited slight erythema, which cleared by 48 hours. No other dermal irritation was observed throughout the study.

Any other information on results incl. tables

Table 1: Individual Animal Dermal Effects
ERYTHEMA
Rabbit Number	Evaluation after Removal of Test Substance
	1 Hour	24 Hours	48 Hours	72 Hours
27900	0	0	0	0
27901	0	0	0	0
28034	0	1	0	0
EDEMA
Rabbit Number	Evaluation after Removal of Test Substance
	1 Hour	24 Hours	48 Hours	72 Hours
27900	0	0	0	0
27901	0	0	0	0
28034	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EEC Directive 91/325

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). No dermal irritation was observed in any rabbit by 1 hour after patch removal. By 24 hours, 1 rabbit exhibited slight erythema which cleared by 48 hours.

Executive summary:

The test substance was evaluated for acute skin irritation potential in 1 male and 2 female New Zealand White rabbits. Approximately 0.5 mL was administered to a localized test site on the back of each animal. The test sites were covered with a semi-occlusive dressing to ensure contact between the skin and test substance. The animals were exposed to the test substance for 4 hours. The test sites were evaluated and scored according to a numerical scale, 1, 24, 48, and 72 hours after the end of the 4-hour exposure period. No dermal irritation was observed in any rabbit by 1 hour after patch removal. By 24 hours, 1 rabbit exhibited slight erythema which cleared by 48 hours.