2-cyclohexylidene-2-phenylacetonitrile

Endpoint summary

Description of key information

Test substance 2-cyclohexylidene-2-phenylacetonitrile was found to be toxic by oral route in acute category IV whether it is not harmful by dermal and inhalation exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from test report

Qualifier:

according to guideline

Guideline:

other: 92/69/EEC, B1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: (HanIbm:WIST (SPF))

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Route of administration:

oral: unspecified

Vehicle:

corn oil

Doses:

500,625,750 mg/kg bw

No. of animals per sex per dose:

5 animals per dose/sex

Control animals:

not specified

Details on study design:

No details available

Statistics:

No details available

Sex:

male/female

Dose descriptor:

LD50

Effect level:

619 mg/kg bw

Based on:

test mat.

95% CL:

528.45 - 707.12

Remarks on result:

other: Slope of the mortality curve: 7.52

Mortality:

Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 1Male: 625 mg/kg bw; Number of animals: 5; Number of deaths: 2Male: 750 mg/kg bw; Number of animals: 5; Number of deaths: 327Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 625 mg/kg bw; Number of animals: 5; Number of deaths: 4Female: 750 mg/kg bw; Number of animals: 5; Number of deaths: 5

Clinical signs:

other: Signs of toxicity related to dose levels:All deaths occurred on day 2 or 3 with the exception of 1 female who died on day 5.The following clinical signs were observed in animals from all dose groups between 1 hour and 8 days or until death occured:sedatio

Gross pathology:

Effects on organs:In the animals which were necropsied at termination of observation, no macroscopic organ findings were noted. In those who died spontaneously, stomach distended with gas was frequently observed. No other macroscopic abnormalities were noted.

Other findings:

No data

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

In acute oral toxicity by standard acute method test material 2-cyclohexylidene-2-phenylacetonitrile was applied at dose concentration 500,625,750 mg/kg bw on male and female HanIbm:WIST (SPF) rat resulted in LD50=619 mg/kg bw with 95% confidence level 528.45 — 707.12 and Slope of the mortality curve: 7.52.

Executive summary:

In acute oral toxicity by standard acute method test material 2-cyclohexylidene-2-phenylacetonitrile was applied at dose concentration 500,625,750 mg/kg bw on 5 male and female HanIbm:WIST (SPF) rat in vehicle corn oil.

At all dose concentration rat showed the following effects:

Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 1

Male: 625 mg/kg bw; Number of animals: 5; Number of deaths: 2

Male: 750 mg/kg bw; Number of animals: 5; Number of deaths: 3

Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 625 mg/kg bw; Number of animals: 5; Number of deaths: 4

Female: 750 mg/kg bw; Number of animals: 5; Number of deaths: 5

Clinical signs :

Signs of toxicity related to dose levels: All deaths occurred on day 2 or 3 with the exception of 1 female who died on day 5. The following clinical signs were observed in animals from all dose groups between 1 hour and 8 days or until death occured: sedation, dyspnea, ruffled fur, hunched posture, lying on stomach, emaciation. The body weight gain of the animals which survived the observation period was normal.

Gross pathology:

Effects on organs: In the animals which were necropsied at termination of observation, no macroscopic organ findings were noted. In those who died spontaneously, stomach distended with gas was frequently observed. No other macroscopic abnormalities were noted.

At the end of the experiment the LD50 value resulted in 619 mg/kg bw with 95% confidence level 528.45 — 707.12 and Slope of the mortality curve: 7.52.

Overall result indicate that the test substance 2-cyclohexylidene-2-phenylacetonitrile is categorized in acute oral toxicity IV as per the CLP criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

619 mg/kg bw

Quality of whole database:

Data is K2 level from study report to which permission to refer granted by ECHA

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from test report

Qualifier:

according to guideline

Guideline:

other: 92/69/EEC

GLP compliance:

yes

Test type:

other: no data

Limit test:

yes

Species:

rat

Strain:

other: (HanIbm: WIST (SPF))

Sex:

male/female

Details on test animals or test system and environmental conditions:

No details available

Type of coverage:

occlusive

Vehicle:

other: none

Details on dermal exposure:

No data

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

No data

Statistics:

No data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: confidence limit not available

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels:There were no systemic signs of toxicity.

Gross pathology:

Effects on organs:There were no macroscopic abnormalities seen.

Other findings:

Signs of toxicity (local):There were no local signs of toxicity.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

In acute dermal toxicity test material 2-cyclohexylidene-2-phenylacetonitrile was applied at dose concentration 2000 mg/kg bw on male and female HanIbm:WIST (SPF) rat resulted in LD50=>2000 mg/kg bw .

Executive summary:

In acute dermal toxicity test material 2-cyclohexylidene-2-phenylacetonitrile was applied dose concentration 2000 mg/kg bw for 24 hrs exposure period on 5 male and female HanIbm:WIST (SPF) rat with no vehicle.

At this dose concentration rat showed the following effects:

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:There were no systemic signs of toxicity.

Gross pathology:

Effects on organs:

There were no macroscopic abnormalities seen.

Other findings:

Signs of toxicity (local):There were no local signs of toxicity.

At the end of the experiment the LD50 value resulted in >2000 mg/kg bw.

Overall result indicate that the test substance 2-cyclohexylidene-2-phenylacetonitrile is not classified as per the CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is K2 level from study report to which permission to refer granted by ECHA

Additional information

Acute toxicity:Oral:

In acute oral toxicity by standard acute method test material 2-cyclohexylidene-2-phenylacetonitrile was applied at dose concentration 500,625,750 mg/kg bw on 5 male and female HanIbm:WIST (SPF) rat in vehicle corn oil.

At all dose concentration rat showed the following effects:

Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 1

Male: 625 mg/kg bw; Number of animals: 5; Number of deaths: 2

Male: 750 mg/kg bw; Number of animals: 5; Number of deaths: 3

Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 625 mg/kg bw; Number of animals: 5; Number of deaths: 4

Female: 750 mg/kg bw; Number of animals: 5; Number of deaths: 5

Clinical signs :

Signs of toxicity related to dose levels: All deaths occurred on day 2 or 3 with the exception of 1 female who died on day 5. The following clinical signs were observed in animals from all dose groups between 1 hour and 8 days or until death occured: sedation, dyspnea, ruffled fur, hunched posture, lying on stomach, emaciation. The body weight gain of the animals which survived the observation period was normal.

Gross pathology:

Effects on organs: In the animals which were necropsied at termination of observation, no macroscopic organ findings were noted. In those who died spontaneously, stomach distended with gas was frequently observed. No other macroscopic abnormalities were noted.

At the end of the experiment the LD50 value resulted in 619 mg/kg bw with 95% confidence level 528.45 — 707.12 and Slope of the mortality curve: 7.52.

Overall result indicate that the test substance2-cyclohexylidene-2-phenylacetonitrile is categorized in acute oral toxicity IVas per the CLP criteria.

Acute toxicity: inhalation:

The chemical 2-cyclohexylidene-2-phenylacetonitrile has a low vapour pressure and thus exposure by the inhalation route is highly unlikely. Thus, the chemical is not likely to have acute toxicity effects via the inhalation route.

Acute toxicity:dermal :

In acute dermal toxicity test material 2-cyclohexylidene-2-phenylacetonitrile was applied dose concentration 2000 mg/kg bw for 24 hrs exposure period on 5 male and female HanIbm:WIST (SPF) rat with no vehicle.

At this dose concentration rat showed the following effects:

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:There were no systemic signs of toxicity.

Gross pathology:

Effects on organs:

There were no macroscopic abnormalities seen.

Other findings:

Signs of toxicity (local):There were no local signs of toxicity.

At the end of the experiment the LD50 value resulted in >2000 mg/kg bw.

Overall result indicate that the test substance2-cyclohexylidene-2-phenylacetonitrile is not classified as per the CLP criteria.

Justification for selection of acute toxicity – oral endpoint
In acute oral toxicity by standard acute method test material 2-cyclohexylidene-2-phenylacetonitrile was applied at dose concentration 500,625,750 mg/kg bw on male and female HanIbm:WIST (SPF) rat resulted in LD50=619 mg/kg bw with 95% confidence level 528.45 — 707.12 and Slope of the mortality curve: 7.52.

Justification for selection of acute toxicity – inhalation endpoint
The chemical 2-cyclohexylidene-2-phenylacetonitrile has a low vapour pressure and thus exposure by the inhalation route is highly unlikely. Thus, the chemical is not likely to have acute toxicity effects via the inhalation route.

Justification for selection of acute toxicity – dermal endpoint
In acute dermal toxicity test material 2-cyclohexylidene-2-phenylacetonitrile was applied at dose concentration 2000 mg/kg bw on male and female HanIbm:WIST (SPF) rat resulted in LD50=>2000 mg/kg bw .

Justification for classification or non-classification

On the basis of information available, the substance 2-cyclohexylidene-2-phenylacetonitrile toxic by oral route in acute category IV and not expected to be toxic by inhalation and dermal exposure.