Registration Dossier
Registration Dossier
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EC number: 627-132-7 | CAS number: 1227096-04-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- other: secondary literature
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insuficient for assessment (abstract with minimum details)
Data source
Reference
- Reference Type:
- other: Letter to EPA under TSCA 8e procedure
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC Number:
- 627-132-7
- Cas Number:
- 1227096-04-9
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- Test material form:
- solid
- Details on test material:
- - Chemical name: N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC number: 627-132-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data available
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- no data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 1.1, 5.3, 28.8 and 261.9 mg/kg/d (male)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
0, 1.1, 5.4, 27.1 and 264 mg/kg/d (female)
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Details on study design:
- no data available
Examinations
- Observations and examinations performed and frequency:
- no data available
- Sacrifice and pathology:
- no data available
- Statistics:
- no data available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- - Organ weight effects were observed at the highest dose level of 250mg/kg/day wherein lower terminal BW were accompanied by a corresponding secondary increase in the relative organ/body weight ratio for adrenal, kidney, liver and testes.
- At the highest dose level, the principal response was an infiltrate of inflammatory cells within the jejunum of the small intestine, mesenteric lymph node, spleen, mediastinal lymph node, interstitium of the ovary and possibly the liver. At the next lower dose level, target tissues were limited to the jejunum and the mesenteric lymph nodes.
No other data available.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1.1 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Documentation insufficient to perform a scientific assessment of the study.
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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