Registration Dossier
Registration Dossier
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EC number: 249-670-8 | CAS number: 29508-47-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Combined repeated dose toxicity with reproduction/ developmental toxicity screening test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Repeated dose oral toxicity study for CAS no 98-94-2
- Author:
- OECD Screening Information Data Sets
- Year:
- 2 012
- Bibliographic source:
- CoCAM 2, 17-19 April 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed for Cyclohexanamine, N,N-dimethyl-(DMCHA) by the OECD 422 method
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohexanamine, N,N-dimethyl-
- Cas Number:
- 98-94-2
- Molecular formula:
- C8H17N
- IUPAC Name:
- Cyclohexanamine, N,N-dimethyl-
- Details on test material:
- - Name of test material: Cyclohexanamine, N,N-dimethyl-(DMCHA)
- Molecular formula: C8H17N
- Molecular weight: 127.229 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Cyclohexanamine, N,N-dimethyl-(DMCHA)
- Molecular formula: C8H17N
- Molecular weight: 127.229 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): No data
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Feed
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose levels upto 1500 ppm (equivalent to 91-104 and 85-147 mg/kg bw/day for males and females, respectively)
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: upto 1500 ppm (equivalent to 91-104 and 85-147 mg/kg bw/day for males and females, respectively)
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- ≥ 28 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No systemic or local toxic effects were noted
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No data
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 104 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
- Remarks on result:
- other: 91-104 mg/Kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 147 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
- Remarks on result:
- other: 85-147 mg/Kg bw/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) for Cyclohexanamine, N,N-dimethyl-(DMCHA) is considered to be 1500 ppm (equivalent to 91-104 and 85-147 mg/kg bw/day for males and females, respectively).
- Executive summary:
Combined repeated dose toxicity with reproduction/ developmental toxicity screening test was performed as per the OECD 422 to determine the toxic nature of Cyclohexanamine, N,N-dimethyl-(DMCHA). The study was performed using male and female rats at dose levels up to 1500 ppm(equivalent to 91-104 and 85-147 mg/kg bw/day for males and females, respectively) by the oral feed method. Repeated dietary administration of DMCHA did not produce systemic or local toxicity. Based on these considerations, the No observed adverse effect level (NOAEL) forCyclohexanamine, N,N-dimethyl-(DMCHA) is considered to be1500 ppm (equivalent to 91-104 and 85-147 mg/kg bw/day for males and females, respectively)
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