Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide; 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[(2-oxoazepane-1-carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide

EC Number:

603-188-8

Cas Number:

127184-53-6

Molecular formula:

Exact identification is not feasible

IUPAC Name:

2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide; 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[(2-oxoazepane-1-carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide

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 or test system 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:

other: No signs of toxicity or treatment related effects were observed.

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.