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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-03-06 to 1986-03-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test substance: Isophorone diisocyanate, homopolymer, caprolactam-blocked

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 5 males and 5 females: total mean 221.9 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) after 16 h of fasting
- Volume administered or concentration: 20 ml/kg bw
- Post dose observation period: 14 days
DOSAGE PREPARATION:
- 50 % suspension in corn oil
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days after treatment
- Clinical signs and mortality: within 6 hours after treatment,  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
Based on:
test mat.
Remarks on result:
other: no mortalities
Mortality:
No mortalities were observed.
Clinical signs:
No signs of toxicity or treatment related effects were observed.
Body weight:
Body weight gain was not affected.
Gross pathology:
- Terminal necropsy: partial hyperemia of small intestine mucosa in two animals; hyperemia of stomach mucosa in one animal; forestomach covered
with a white film in one of these animals
Other findings:
no other findings

Any other information on results incl. tables

no other results

Applicant's summary and conclusion

Conclusions:
The LD50 value (oral) of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopolymer, caprolactam-blocked) in female and male rats was estimated to be > 10000 mg/kg bw. No mortalities were observed. Necropsy showed  partial 
hyperemia of small intestine mucosa and stomach mucosa were observed only in two animals. Therefore, under the conditions of this study the acute toxicity of IPDI homopolymer, caprolactam-blocked after oral exposure in rats is very low.
Executive summary:

In this standard acute method cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopolymer, caprolactam-blocked) was administered in a single dose of 10000 mg/kg bw to 5 male and 5 female Wistar rats. The animals were observed for mortality and any sub-lethal effects for 14 days after dosing. No signs of toxicity or treatment related effects were observed, no death occurred during the study. Necropsy showed  partial  hyperemia of small intestine mucosa and stomach mucosa were observed only in two animals.

According to this study the LD50 value (oral) was determined to be > 10000 mg/kg bw. Therefore, under the conditions of this study the acute toxicity of IPDI homopolymer, caprolactam-blocked after oral exposure in rats is very low.