Registration Dossier

Diss Factsheets

Administrative data

Description of key information

- Acute Dermal Irritation/Corrosion (OECD TG 404): no skin irritation for rabbit
- Acute Eye Irritation/Corrosion (OECD TG 405): no eye irritation for rabbit
- There was no evidence of respiratory irritation reported in the acute inhalation toxicity in rats.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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)
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 25, 1995 To December, 1995.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP OECD guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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: 7am-7pm)
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Single administration, not rinsed.
Observation period (in vivo):
60 min, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : No


SCORING SYSTEM: The ocular reaction has been scored according to the scale proposed by the 405 OECD guideline.

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Cornea, iris and conjunctivae: no modification was observed in any animal and at any timepoint.
Other effects:
No animals died.
No clinical signs or behavioral alterations were noted.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this test, 1,6 Divinylperfluorohexane is to be considered "non irritant" for the eye.
Executive summary:

In an acute eye irritation study, young adult New Zealand white rabbits (3 animals) were in the conjunctival sac of the right eye of each animal exposed to 0.1 mL of the test article (1,6 Divinylperfluorohexane). The eye was observed at 1, 24, 48 and 72 hours after the test application. No animals died. No clinical signs or behavioral alterations were noted. No modification of cornea, iris and conjunctivae was observed in any animal. The test article, when administered by ocular route to rabbits under the experimental conditions adopted, is to be considered "non irritant" for the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin and eye corrosion/irritation assessment:

For each irritation/corrosion endpoint, a reliable study is available:

Skin corrosion/irritation:

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.

Eye corrosion/irritation:

In an acute eye irritation study, young adult New Zealand white rabbits (3 animals) were administered 0.1 ml of the test article 1,6 Divinylperfluorohexane in the conjunctival sac of the right eye. The eye was observed at 1, 24, 48 and 72 hours after the test application. No animals died. No clinical signs or behavioral alterations were noted. No modification of cornea, iris and conjunctivae was observed in any animal. The test article, when administered by ocular route to rabbits under the experimental conditions adopted, is to be considered "non irritant" for the eye.

Therefore, based on available in vivo studies with rabbits, the test substance is not classified for skin and eye irritation according to DSD and CLP regulation.


Justification for selection of skin irritation / corrosion endpoint:
Study performed according to OECD TG 404 and EC method B.4.

Justification for selection of eye irritation endpoint:
Study performed according to OECD TG 405 and EC method B.5.

Justification for classification or non-classification

The test material appears to have no skin or eye irritant effect in in vivo studies with rabbits. Therefore, 1,6 Divinylperfluorohexane does require classification for skin and eye irritation according to the criteria of the CLP regulation EC No. 1272/2008.

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