3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 19, 1995 To December, 1995.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP OECD guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

EC Number:

217-288-0

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Cas Number:

1800-91-5

Molecular formula:

C10H6F12

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Constituent 2

Reference substance name:

1,6 Divinylperfluorohexane

IUPAC Name:

1,6 Divinylperfluorohexane

Test material form:

other: Liquid

Test animals

Species:

rabbit

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cornelli s.n.c.
- Age at study initiation: 2-3 months
- Weight at study initiation: 2/3 kg
- Housing: individual caging in air conditioned room ; grill cages 62x47.5x38 cm
- Diet: GLP 2RB15 (Mucedola S.r.l. Settimo M.se)
- Water: ad libitum
- Acclimation period: at least 7 days before test start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 50 +/-15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12h/12h (light: 7 am-7 pm)

Test system

Type of coverage:

not specified

Preparation of test site:

other: cleared dorsal area

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

1st animal: 3 minutes, 1 hour and 4 hours
other 2 animals: 4 hours

Observation period:

1st animal (3 min-exposure): 3 min, and 72 hours
1st animal (1 hour-exposure): 1 hour, and 72 hours
all 3 animals (4 hour-exposure): 60 min, 24, 48, and 72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk of the animals
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: the skin reaction has been scored according to the scale proposed by OECD 404 guideline.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

At the application sites and at all observation times, no signs of dermal irritancy were noted in any rabbit.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this test, 1,6 Divinylperfluorohexane is not irritanting to the skin.

Executive summary:

In an acute dermal irritation study, young adult New Zealand white rabbits (3 animals) were dermally exposed to 0.5 mL of the test article (1,6 Divinylperfluorohexane) for 3 minutes, 1 hour and 4 hours. Test material was applied uniformly by gentle inunction onto the cleared dorsal area of the trunk of the animals. The test site was observed immediately after the 3 minute and the 1 hour- exposure period and at 72 hours in the first rabbit, and at 1, 24, 48 and 72 hours after the 4 -hour exposure period (all rabbit). No animals died. No clinical signs or behavioral alterations were noted. At the application sites, no signs of dermal irritancy were noted in any rabbit. The test article, when administered by dermal route to rabbits under the experimental conditions adopted, is to be considered "non irritant" for the skin.