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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-02-16 to 1998-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate; (propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate

EC Number:

600-028-9

Cas Number:

1001254-87-0

Molecular formula:

Exact identification is not feasible

IUPAC Name:

(propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate; (propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate

Test material form:

other: solid

Details on test material:

Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked) of Hüls AG, current production, solvent free

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: 
- Strain: Cpb/Win:WU (SPF)
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- healthy, young adult animals
- Controls: no
- Fasting period before study: 16 hours
- Diet: ad libitum, R10 special diet for rats, SSniff R
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

ADMINISTRATION: 
- test compound was grinded and suspended in corn oil
- 20 g/100ml
- Doses per time period: single dose (gavage)
- Volume administered : 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

EXAMINATIONS: 
- Mortality, clinical signs: soon after dosing and at frequent intervals for day 0, than once daily for next 2 weeks
- Body weights: days 0, 7, and 14
- Post dose observation period: 14 days
- Macroscopic examination: directly after exitus (animal that died) / day  14 (surviving animals)

Statistics:

not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred. 

Clinical signs:

other: No signs of systemic reaction to treatment.

Gross pathology:

NECROPSY FINDINGS: Macroscopical examination revealed no abnormalities.

Other findings:

no other findings

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:

According to this study the LD50 value (oral) was estimated to be > 2000 mg/kg bw in rats for the test item.

Executive summary:

In an acute oral toxicity study (limit test) according OECD 401 a single dose of 2000 mg/kg  test item was applied to three male and female Wistar rats.

The observation period was 14 days.

There were no deaths and no signs of systemic reaction to treatment, body weight development was normal.

Macroscopical examination revealed no abnormalities at the end of the observation period.

Under conditions of this study the LD50 value (oral) is above 2000 mg/kg bw in Wistar rats.