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Registration Dossier
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EC number: 200-261-2 | CAS number: 56-18-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3,3'-iminodi(propylamine)
- EC Number:
- 200-261-2
- EC Name:
- 3,3'-iminodi(propylamine)
- Cas Number:
- 56-18-8
- Molecular formula:
- C6H17N3
- IUPAC Name:
- bis(3-aminopropyl)amine
- Details on test material:
- - Analytical purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma WIGA (Sulzfeld)
- Weight at study initiation: male animals 140g, female animals 130g
- all animals are healthy with unharmed skin
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm2
- Type of wrap if used: aluminium foil fixed with stickytape
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or water/lutrol mixture
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 200, 400 and 640 mg/kg
- Concentration: 25% and 50% - Duration of exposure:
- 24 h
- Doses:
- 200, 400 and 640 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations and weighing: 1 h, 1, 2, 8 , 14 and 21 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:
- 200 - 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 200 mg/kg; none of the animals died after 14 days
400 mg/kg; 3/5 males and 5/5 females after 21 days
640 mg/kg: all animals died after 24 h - Clinical signs:
- other: Apathy, 24 hours after application necrosis was observed on all animals
- Gross pathology:
- Diseased animals
400-640 mg/kg: dilation and acute congestion hyperaemia of the heart, obvious almost infarctious bloody lungs
640 mg/kg: bright kidneys
Euthanized animals
No abnormal findings
Applicant's summary and conclusion
- Executive summary:
In a dermal toxicity study, comparable to OECD 402, dipropylenetriamine was applied in olive oil occlusively at single doses of 200 to 640 mg/kg to Sprague-Dawley rats (5/sex/dose).
The LD50 falls between 200 and 400 mg/kg bw.
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