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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
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.

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