Registration Dossier
Registration Dossier
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EC number: 230-819-0 | CAS number: 7328-91-8
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- according to BASF-internal standard
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diamine
- EC Number:
- 230-819-0
- EC Name:
- 2,2-dimethylpropane-1,3-diamine
- Cas Number:
- 7328-91-8
- Molecular formula:
- C5H14N2
- IUPAC Name:
- 2,2-dimethylpropane-1,3-diamine
- Details on test material:
- Name of the test substance used in the study report: Neopentandiamin (= 1,3-Diamino-2,2-dimethylpropan)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- A standardized animal laboratory diet was used.
Fasting period: 15 - 20 h before administration.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test concentrations used were 6.81, 10 and 14.7% (G/V); aqueous solution.
Application volume: 10 ml/kg. - Doses:
- 681, 1000, and 1470 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 020 mg/kg bw
- Mortality:
- Male animals: 681 mg/kg: 1/5 after 14 days; 1000 mg/kg: 3/5 after 14 days; 1470 mg/kg: 5/5 after 14 days
Female animals: 681 and 1000 mg/kg: no deaths after 14 days; 1470 mg/kg: 5/5 after 14 days - Clinical signs:
- Dyspnea, gasping, apathy, abnormal position, staggering, atony, pain and cornea reflexes missing, spastic gait, urine intense yellow-coloured, ruffled fur, exophthalmos, blood in the nose, breathlessness, poor general state
- Body weight:
- Mean body weight for male animals: 260 g at study start, 318 g after 13 days
Mean body weight for female animals: 187 g at study start, 253 g after 13 days - Gross pathology:
- Animals that died: heart: acute dilatation (right), acute congestive hyperemia; lung: acute flatulence (middle-graded); liver: peripheral lobular pattern; stomach: dilated, atonic, glandular stomach diffusely reddened (severe irritative gastritis); intestine: diffuse reddening of the mucosa, atonic, diarrheic content (enteritis).
Sacrificed animals: nothing abnormal detected.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 acute oral was 1020 mg/kg bw.
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