Registration Dossier
Registration Dossier
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EC number: 634-657-5 | CAS number: 65962-45-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non guideline dose range finding study, not conducted in accordance with GLP. Raw data available.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: 14d-Dose Range Finding Study
- Principles of method if other than guideline:
- The main objective of the study is to assess whether rats tolerate the test substance at offered concentration by gavage in order to select dose levels in an adequate form of administration for subsequent studies.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine
- EC Number:
- 634-657-5
- Cas Number:
- 65962-45-0
- Molecular formula:
- C17H34N2
- IUPAC Name:
- 4-[(4-amino-3,5-dimethylcyclohexyl)methyl]-2,6-dimethylcyclohexan-1-amine
- Details on test material:
- Test substance No.: 10/0408-2
Batch identification: 45296088Q0
Purity: Sum of isomers: 99.1 area-% (water content accounted for)
Homogeneity: given (visually)
Stability: given until 28 Feb 2014
The stability of the test substance under storage conditions over the test period was guaranteed by the sonsor and the sponsor holds this responsibility.
Date of production: 16 Jan 2011
Physical state/appearance: liquid/colorless to yellowish
Storage conditions: room temperature, avoid temperatures >50°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- two weeks
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, and 150 mg/kg bw
Basis:
nominal in water
- No. of animals per sex per dose:
- four
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- Mortality
A check for moribund and dead animals will be made twice daily from Monday to Friday and once daily on Saturday, Sunday and public holidays.
Clinical signs
Animals will be checked daily for any abnormal clinical signs before the administration, as well as, within 2 hours and within 5 hours after the administ
Food consumption
Food consumption will be determined on study day 3, 7, 10 and 14 and calculated as mean food consumption in gram per animal and day.
Drinking water consumption
Drinking water consumption will be determined on study day 3, 7, 10 and 14 and calculated as mean water consumption in gram per animal and day.
Body weight
Body weight will be determined before the start of the administration period in order to randomize the animals. During the administration period the body weight will be determined on day 0, 3, 7, 10 and 14. The difference between the body weight on the respective day of weighing and the body
weight on day O will be calculated as body weight change.
CLINICAL PATHOLOGY
Blood samples will be taken from fasted animals by puncturing the retrobulbar venous plexus under isoflurane anesthesia. Blood sampling and examination will be carried out in a randomized sequence. - Sacrifice and pathology:
- Necropsy
All animals will be sacrificed by decapitation under isoflurane anesthesia. The exsanguinated animals will be necropsied and assessed by gross pathology, special attention being given to the reproductive organs. Animals which die intercurrently or are sacrificed in a moribund state will be necropsied as soon as possible after their death and assessed by gross pathology
Organ weights
The following weights will be determined in all animals sacrificed on schedule:
1. Anesthetized animals
2. Adrenal glands
3. Heart
4. Kidneys
5. Liver
6. Spleen
Organ/Tissue fixation
The following organs or tissues will be fixed in 4% buffered formaldehyde solution:
1. All gross lesions
2. Adrenal glands
3. Heart
4. Kidneys
5. Liver
6. Spleen
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
50 mg/kg bw
findings:
salivation in 3/4 males and females
piloerection in 4/4 males and females
food consumption
decreased over entire study period in all males and in females from study days 3 to 14
water consumption
NAD
body weight
decreased in males on study days 7, 10 and 14 as well as in females on study days 7 and 14
body weight change
decreased in males and females over the entire study period
organ weights
absolute terminal body weights: decrease in males and females
adrenal glands and heart: relative weight increased in males
kidneys: relative weight increase in males and females
liver: relative weight increase in males and females
gross lesions
NAD
microscopic lesions
necrosis/fibrosis of the myocard of the heart in 2/4 male and 214 female animals mostly in the septal area
150 mg/kg bw
findings
premature death in 1/4 males on study day 6
poor general condition in 3/4 males and 4/4 females
salivation 2/4 males and 3/4 females
limbs paresis 1/4 males and 2/4 females
ataxia in 1/4 males and 2/4 females
unsteady gait in 1/4 males
all animals were sacrificed in moribund state on study day 6
food consumption
decreased in males and females from study days 0 to 3
water consumption
NAD
body weight
decreased in males on study day 3
body weight change
decreased in males from study day 0 to 3
gross lesions
forestomach erosion/ulcer in 4/4 males and females
grandular stomach erosion/ulcer in 1 /4 males
enlarged liver 4/4 males and females
discoloration of spleen 4/4 males and females
microscopic lesions
necrosis/fibrosis of the myocard of the heart in all male and female animals mostly in the septal area
Applicant's summary and conclusion
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.
