3-(isodecyloxy)propiononitrile

Endpoint summary

Description of key information

Ethernitrile-C10i was found to be not irritating to the skin and minimally irritating to the eyes.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: New Zealand albino rabbit
Origin: Chartes River Deutschland GmbH; Stolzenseeweg 32 - 36; 88353 Kißlegg
Number of animals: 3
Body weight at start of the study: 2.8 - 3.2 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20 ±3°C
Relative humidity: 50±20 %
Lighting time: 12 hours daily
Acelimatization: 1 week under study eonditions
Food: ssniff' K-H (V2333), ad libitum and hay (approx. 15g daily)
Water: water from automatie water dispensers, ad libitum
Animal identifieation: numbered ear tags

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5ml per patch

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 mL Isodecylethernitril. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

24 hours after removal of the piaster very slight erythema were observed in all animals. 48 hours after removal of the piaster all signs of irritation were reversible.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated:

Erythema and eschar formation
all animals: 0.3
animal 22: 0.3
animal 39: 0.3
animal 89: 0.3

Oedema formation
all animals: 0.0
animal 22: 0.0
animaI 39: 0.0
animal 89: 0.0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of Isodecylethemitril for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.

Executive summary:

Testing of Isodecylethemitril for primary dermal irritation in the rabbit showed, that the substance is not irritating to 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: New Zealand albino rabbit
Origin: Chartes River Deutschland GmbH; Stolzenseeweg 32 - 36; 88353 Kißlegg
Number of animals: 3
Body weight at start of the study: 3.1 - 3.9 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20 ±3°C
Relative humidity: 50±20 %
Lighting time: 12 hours daily
Acelimatization: 1 week under study eonditions
Food: ssniff' K-H (V2333), ad libitum and hay (approx. 15g daily)
Water: water from automatie water dispensers, ad libitum
Animal identifieation: numbered ear tags

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml per eye

Duration of treatment / exposure:

24h

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Details on study design:

About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

0.1 ml Isodecylethernitril was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C.

The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for cornealiesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in comea, iris or conjunctivae were graded numerically.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One hour after application the conjunctivae the animals showed a diffuse crimson red up to a diffuse beefy red colour and very slight swellings. Additionally, clear·colourless eye discharge was noted. 24 hours after application a diffuse crimson colour of the cunjuntivae were observed in two anima/so 48 hours after application all signs of irritation were reversible.

Based on the individual scores after 24, 48 and 72 hours, the following mean values
were calculated:
Opacity of cornea all animals 0.0 Iris all animals 0.0
animal 39 0.0 animal 39 0.0
animal 83 0.0 animal 83 0.0
animal 87 0.0 animal 87 0.0
Redness of conjunctiva all animals 0.44 Chemosis of conjunctiva all animals 0.0
animal 39 0.00 animal 39 0.0
animal 83 0.66 animal 83 0.0
animal 87 0.66 animal 87 0.0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of Isodecylethernitril for primary eye irritation in the rabbit showed, that the substance is practically not irritating to eye.

Executive summary:

Testing of Isodecylethernitril for primary eye irritation in the rabbit showed, that the substance is practically not irritating to eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion:

Ethernitrile-C10i was tested in anin vivodermal irritation/corrosion study on rabbit skin according to OECD TG 404. Three NZW rabbits received 0.5 mL of undiluted test substance under semi-occlusive conditions on the clipped skin for 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

24 hours after removal of the plaster very slight erythema was observed in all animals, which was completely cleared the next day. None of the application sites showed oedema at any observation point. Average scoring from 24, 48 and 72 hours for erythema and eschar formation was 0.3.

The study concluded that Ethernitrile-C10i is not irritating to skin.

 

Eye irritation:

Ethernitrile-C10i was tested in anin vivoeye irritation study in rabbit skin according to OECD TG 405. Three NZW rabbits received 0.1 mL of undiluted test substance in the conjunctival sac of the left eye.

24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV.

One hour after application the conjunctivae the animals showed a diffuse crimson red up to a diffuse beefy red colour and very slight swellings. Additionally, clear·colourless eye discharge was noted.

24 hours after application a diffuse crimson colour of the conjunctivae were observed in two animals, and 48 hours after application all signs of irritation were found reversible.

Based on the individual scores after 24, 48 and 72 hours, a mean value for redness of conjunctiva in all animals of 0.44 was calculated. No corneal opacity, iris lesions or chemosis have been observed at any time point.

The report concluded that Ethernitrile-C10i is practically not irritating to eye.

Justification for classification or non-classification

Thein vivodermal corrosion study in rabbits showed that Ethernitrile-C10i is not irritating to the skin.

The in vivo study for eye irritation resulted only to redness of conjunctiva. However, these effects were found to be fully reversible within 48 hours, and the scoring did not reach sufficient severity for classification according GHS or CLP.

 

There is no information is available following exposure via inhalation, but based on the available data, there is no need to consider potential respiratory irritation. The use is limited to intermediate in industrial manufacture and does not result in aerosols, particles or droplets of an inhalable size. The potential for inhalation of vapours is therefore is low.