Registration Dossier
Registration Dossier
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EC number: 256-233-5 | CAS number: 45320-65-8
Endpoint summary
Administrative data
Description of key information
A LD50 value of > 2000 mg/kg can be established for N, N’-[(methylimino)bis (trimethylene)]bis(oleamide).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The toxicity of N,N’[(methylimino)bis(trimethylene)]bis(stearamide) after oral administration was investigated in a study similar to OECD guideline 423 by (gavage) to Sprague Dawley rats. These data were used to evaluate the acute oral toxicity of N, N’-[(methylimino)bis (trimethylene)]bis(oleamide).
An LD50 value of > 2000 mg/kg can be established for N, N’-[(methylimino)bis (trimethylene)]bis(oleamide).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
The toxicity of N,N’[(methylimino)bis(trimethylene)]bis(stearamide) after oral administration was investigated in a study similar to OECD guideline 423 by (gavage) to Sprague Dawley rats. These data were used to evaluate the acute oral toxicity of N, N’-[(methylimino)bis (trimethylene)]bis(oleamide).
An LD50 value of > 2000 mg/kg can be established for N, N’-[(methylimino)bis (trimethylene)]bis(oleamide).
Further testing for inhalation or dermal route
Testing on vertebrate animals for the purpose of REACH shall be undertaken only as a last resort. The acute intrinsic toxicity after oral exposure of N,N'-[(methylimino)bis(trimethylene)] bis(oleamide) is considered to be low; a LD50 value of > 2000 mg/kg was established. Further testing on vertebrate animals for acute toxicity via inhalation or dermal route is scientifically not necessary, taken into account available information reflecting low intrinsic toxicity. In conclusion the occurrence of a systemic toxicity after inhalation or dermal exposure relevant to humans is unlikely and therefore the conduct of an acute inhalation toxicity study and/or an acute dermal toxicity study is not justified.
Justification for classification or non-classification
Based on relevant, reliable and adequate data, N, N’-[(methylimino)bis (trimethylene)]bis(oleamide) does not have to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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