Registration Dossier
Registration Dossier
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EC number: 938-351-5 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-11-25 to 1985-12-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, uretdione type
- EC Number:
- 938-351-5
- Molecular formula:
- residual C12H18N2O2, otherwise C24H36N4O4 (dimer) and higher species
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, uretdione type
- Details on test material:
- Isophorone diisocyanate oligomer (uretdione type) of Hüls AG
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 5 males mean 181 g, 5 females mean 178 g
- Controls: no
Environmental conditions: - Feed: R 10 complete feed for rats (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times per hour
- Illumination: 12 hour light/dark rhythm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Details on oral exposure:
- ADMINISTRATION:
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 20 ml/kg bw
- Post dose observation period: 14 days - Doses:
- 10 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days post dosing
- Clinical signs and mortality: within 6 hours after dosing, thereafter daily
- Necropsy: all animals (macroscopic) - Statistics:
- not required
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- MORTALITY: No deaths
- Clinical signs:
- CLINICAL SIGNS:
- 30-60 minutes after dosing: slightly ruffled fur, restlessness
- 2-5 hours after dosing: additionally crouched posture, diuresis and diarrhea
- 24 hours after dosing: ruffled fur and diuresis
- 48 hours after dosing: no more signs of toxicity - Body weight:
- Body weight gain was not affected.
- Gross pathology:
- NECROPSY FINDINGS: partial hyperemia of small intestine mucosa (4 animals), additionally congestion spleen (1 animal); slight hyperemia of
gastric mucosa (1 animal) - Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the acute toxicity of isophorone diisocyanate cyclodimer in Wistar rats was established to exceed
10 000 mg/kg bw. - Executive summary:
The acute oral toxicity study of isophorone diisocyanate cyclodimer was determined with 5 male and 5 female WISTAR rats. Both male and female rats were treated with 10 000 mg/kg bw. Animals were observed for symptoms of clinical toxicity and mortality for 14 days after treatment. The treated animals showed slightly ruffled fur and restlessness 30-60 minutes after dosing, 2-5 hours after dosing additionally crouched posture, diuresis and diarrhea. 24 hours after dosing the rats revealed ruffled fur and diuresis. 48 hours after dosing all rats were free of symptoms. No mortality occured, no apparent changes were found in body weight.
Dissection at the end of the experiment revealed partial hyperemia of small intestine mucosa (4 animals), additionally congestion spleen (1 animal) and slight hyperemia of gastric mucosa (1 animal).
Therefore the oral LD50 value of isophorone diisocyanate cyclodimer in Wistar rats was established to exceed 10 000 mg/kg bw.
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