Registration Dossier
Registration Dossier
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EC number: 200-888-1 | CAS number: 75-64-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- tert-butylamine
- EC Number:
- 200-888-1
- EC Name:
- tert-butylamine
- Cas Number:
- 75-64-9
- Molecular formula:
- C4H11N
- IUPAC Name:
- 2-methylpropan-2-amine
- Details on test material:
- - Name of test material (as cited in study report): tert.-butylamine, substance no. 84/396
- Analytical purity: 98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Fasting period before study: 16 hours
- Housing: groups of 5 in stainless steel wire mesh cages type DK-III
- Diet: Kliba laboratory diet, Klingenthalermuehle AG, Kaiseraugst, Switzerland ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3.61, 4.64, 6.81 (w/v), respectively
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 316, 464, 681 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 316 - < 464 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 514 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 464 mg/kg bw
- Mortality:
- 681 mg/kg dosing group: 5/5 females, 4/5 males (d 1-d 14)
464 mg/kg dosing group: 1/5 females, 5/5 males (d 1-d 14)
316 mg/kg dosing group: no death occurred - Clinical signs:
- other: dyspnoea, apathy, staggering, tremors, piloerection, diarrhea, salivation, stretching, imbalance, poor general condition
- Gross pathology:
- mid and high dosing groups:
haemorrhagic gastritis, bloody content of intestine, acute peritonitis, local adhesions of stomach and liver, single animals with acute serous peritonitis as a result of perforation of the stomach, single animals with very severe tymanitas, one animal with perforated duodenal ulcer, swollen margo plicatus (cuticular ridge)
lowest dosing group:
1 male with acute lung emphysema and haemorrhagic intestinal content, other animals without findings
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.
