Registration Dossier
Registration Dossier
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EC number: 701-003-6 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Written assessment
- Type of information:
- other: Written assessment
- Adequacy of study:
- other information
- Study period:
- December 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Written assessment
- Justification for type of information:
- At the current level of registration, a written assessment is suitable. Please see attached justification below.
- Objective of study:
- other: Written assessment of ADME
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Written assessment based on available study data.
- Details on absorption:
- See above justification
- Details on distribution in tissues:
- See above justificationSee above justification
- Details on excretion:
- See above justification
- Details on metabolites:
- See above justification
- Bioaccessibility (or Bioavailability) testing results:
- See above justification
- Conclusions:
- In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route, but for worst case risk assessment, 100% absorption is proposed. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. This is further confirmed by the extensive metabolic studies conducted on the closely related substance lauramide DEA. Lauramide DEA, following absorption in rodents, is metabolized to the half-acid amides of succinic and of adipic acid. These metabolites would arise from the ω-hydroxylation and eventual β-oxidation to give the chain-shortened products. The metabolism studies conducted by Mathews et al. (1996) on the analogue demonstrate that the amide moiety is not hydrolysed; hence the lack of potential for amine formation. Since ω-hydroxylation and β- oxidation are the only noted means of metabolism (these are common metabolic pathways for dietary fatty acids and triglycerides), there is no possibility that reactive, or potentially mutagenic intermediates, can be formed. The metabolic data on the close structural analogue lauramide DEA corroborates the conclusion that the substance is not considered to be bioaccumulative, and would be metabolised for elimination via urine.
- Executive summary:
In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route, but for worst case risk assessment, 100% absorption is proposed. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. This is further confirmed by the extensive metabolic studies conducted on the closely related substance lauramide DEA. Lauramide DEA, following absorption in rodents, is metabolized to the half-acid amides of succinic and of adipic acid. These metabolites would arise from the ω-hydroxylation and eventual β-oxidation to give the chain-shortened products. The metabolism studies conducted by Mathewset al. (1996) on the analogue demonstrate that the amide moiety is not hydrolysed; hence the lack of potential for amine formation. Since ω-hydroxylation and β- oxidation are the only noted means of metabolism (these are common metabolic pathways for dietary fatty acids and triglycerides), there is no possibility that reactive, or potentially mutagenic intermediates, can be formed. The metabolic data on the close structural analogue lauramide DEA corroborates the conclusion that the substance is not considered to be bioaccumulative, and would be metabolised for elimination via urine.
Reference
Description of key information
This written assessment of the toxicokinetic properties of Reaction products of 1,1’-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic) is based on the results obtained for the toxicological end‑points listed below with simultaneous reference to relevant physico-chemical data:
- Acute oral toxicity
- Acute dermal toxicity
- Skin irritation
- Eye irritation
- Skin sensitisation
- Subacute (28 day) oral toxicity
- Reproduction/Developmental Toxicity Screening test
- Bacterial reverse mutation test
- In vitro chromosome aberration test
- In vitro mammalian gene mutation test
100% absorption is assumed in all cases as a worst case assessment for the purposes of risk assessment. In reality, the substance is thought to be poorly absorbed on the basis of the dataset presented.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
Please refer to attached justification in section 7.1.1.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
