3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime

EC Number:

500-287-7

EC Name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime

Cas Number:

103170-26-9

Molecular formula:

>= C48H81N9O9 (IPDI-Isocyanurate n=3, 2-butanone oxime-blocked)

IUPAC Name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

SPF-bred Wistar rats of the strain Clr:(WI)BR
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: about 10 weeks
- Fasting period before treatment: overnight (maximal 20 h)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

other: Clinical signs as lethargy, hunched posture, laboured respiration, rales, piloerection, uncoordinated movements, and/or chromodacryorrhea were noted among the animals between days 1 and 7.

Gross pathology:

no abnormal findings

Other findings:

none

Any other information on results incl. tables

Dose (mg/kg bw)	Toxicological results	Onset and duration of signs	Onset of mortality
2000	0 / 3 / 3	---	---
2000	0 / 3 / 3	---	---

Toxicological results:

number of dead animals / number of animals with clinical signs after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Wistar rats according to OECD TG 423. The oral dose of 2000 mg/kg bw was tolerated without mortalities, effects on weight gain or gross pathological findings. Clinical signs as lethargy, laboured respiration, piloerection, and/or chromodacryorrhea were noted among the animals between days 1 and 7. The LD50 was determined with > 2000 mg/kg bw.