Registration Dossier
Registration Dossier
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EC number: 207-306-5 | CAS number: 460-19-5
Endpoint summary
Administrative data
Description of key information
Ethanedinitrile
Dermal exposure of rabbits to ethanedinitrile gas in an acute toxicity study indicates that ethanedinitrile is not a skin irritant no skin sensitisation was reported. Dermal exposure of rabbits to 10,000 ppm (~21 g/m3) of ethanedinitrile for eight hours, did not result in any clinical observations or macroscopic effects (McNerney and Schrenk 1960).
Skin sensitation or any other effect to skin was not observed in six-month exposure of monkeys and rats to sublethal doses (11 and 25 ppm) of ethanedinitrile (Lewis et al. 1984).
Cyanides
Relevant literature does not include any information relating to sensitising effects, neither dermal nor respiratory, of hydrogen cyanide and cyanides (WHO 2004). Hydrogen cyanide does not present any structural alert for skin sensitization; standard skin sensitization test is not feasible and sensitizing properties of cyanides or nitriles have not been suggested by the experience in humans over a period of many years of production and use.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because the available in vitro test methods are not applicable for the substance and therefore an in vivo skin sensitisation study was conducted
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Available studies provide sufficient evidence that ethanedinitrile does not have skin sensitisation properties. Therefore LLNA study was not conducted
- GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- Available studies provide sufficient evidence that ethanedinitrile does not have skin sensitisation properties. Therefore LLNA study was not conducted
- Specific details on test material used for the study:
- ethanedinitrile 99.5 %
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- albino rabbits
- Sex:
- male
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 10000 ppm
- No. of animals per dose:
- 4
- Parameter:
- SI
- Value:
- 10 000
- Test group / Remarks:
- 4
- Parameter:
- SI
- Remarks:
- Dermal exposure of rabbits to 10,000 ppm (~21 g/m3) of ethanedinitrile for eight hours, did not result in any clinical observations or macroscopic effects.
- Value:
- 10 000
- Test group / Remarks:
- 4
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Dermal exposure of rabbits to ethanedinitrile gas in an acute toxicity study indicates that ethanedinitrile is not a skin sensitiser. Dermal exposure of rabbits to 10,000 ppm (~21 g/m3) of ethanedinitrile for eight hours, did not result in any clinical observations or macroscopic effects.
- Executive summary:
Dermal exposure of rabbits to ethanedinitrile gas in an acute toxicity study indicates that ethanedinitrile is not a skin sensitiser. Dermal exposure of rabbits to 10,000 ppm (~21 g/m3) of ethanedinitrile for eight hours, did not result in any clinical observations or macroscopic effects.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Whole body exposure
- GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- Available studies provide sufficient evidence that ethanedinitrile does not have skin sensitisation properties. Therefore LLNA study was not conducted
- Specific details on test material used for the study:
- ethanedinitrile 99%
- Species:
- other: albino rat and Rhesus monkey
- Strain:
- other: Charles River Sprague-Dawley COBS and Maccaca mulatta
- Sex:
- male
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0 ppm; 11 ppm; 25 ppm
- Day(s)/duration:
- 180
- No. of animals per dose:
- 5 monkeys per treatment group
30 rats per treatment group - Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 4 320
- Group:
- negative control
- Dose level:
- 11 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Dermal exposure to ethanedinitrile gas indicates that ethanedinitrile is not a skin sensitiser. Skin sensitation or any other effect to skin was not observed in six-month exposure of monkeys and rats to sublethal doses (11 and 25 ppm) of ethanedinitrile.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 4 320
- Group:
- test chemical
- Dose level:
- 11 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Dermal exposure to ethanedinitrile gas indicates that ethanedinitrile is not a skin sensitiser. Skin sensitation or any other effect to skin was not observed in six-month exposure of monkeys and rats to sublethal doses (11 and 25 ppm) of ethanedinitrile.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 4 320
- Group:
- positive control
- Dose level:
- 11 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Dermal exposure to ethanedinitrile gas indicates that ethanedinitrile is not a skin sensitiser. Skin sensitation or any other effect to skin was not observed in six-month exposure of monkeys and rats to sublethal doses (11 and 25 ppm) of ethanedinitrile.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Dermal exposure to ethanedinitrile gas indicates that ethanedinitrile is not a skin sensitiser. Skin sensitation or any other effect to skin was not observed in six-month exposure of monkeys and rats to sublethal doses (11 and 25 ppm) of ethanedinitrile.
- Executive summary:
Dermal exposure to ethanedinitrile gas indicates that ethanedinitrile is not a skin sensitiser. Skin sensitation or any other effect to skin was not observed in six-month exposure of monkeys and rats to sublethal doses (11 and 25 ppm) of ethanedinitrile.
Referenceopen allclose all
Available studies provide sufficient evidence that ethanedinitrile does not have skin sensitisation properties.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
CLP criteria not met
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