3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment, restriction: no data on test substance purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Principles of method if other than guideline:

Method: other: Based on "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA (1959)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers

EC Number:

500-125-5

EC Name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers

Cas Number:

53880-05-0

Molecular formula:

residual C12H18N2O2, otherwise C36H54N6O6 (trimer) and higher species

IUPAC Name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer

Constituent 2

Reference substance name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type

EC Number:

931-312-3

Cas Number:

53880-05-0

Molecular formula:

residual C12H18N2O2, otherwise C36H54N6O6 (trimer) and higher species

IUPAC Name:

3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type

Details on test material:

Test substance: other TS: isophorone diisocyanate homopolymer of Hüls AG, 70 % solution in 2:1 xylene/2-ethoxyethyl acetate (pH: 6.0)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Number of animals: 5 per dose group and sex
- Source: Winkelmann, Paderborn (Germany)
- Weight at study initiation: 115 - 140 g
- Diet: Ssniff/Intermast
- Water: ad libitum
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 22
- Humidity: 45 - 55 %
- Photoperiod (hrs dark/ hrs light): 12 hours/day
- Housing: one per cage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

no details

Doses:

Doses: 10000 (equivalent to 7000 mg/kg bw IPDI homopolymer), 20000 mg/kg bw (equivalent to 14000 mg/kg bw IPDI homopolymer)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Post exposure period: 7 days
Examinations: central nervous system (awareness, emotion, vital symptoms, coordination, tonus, reflexes, autonomic functions)

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 14 000 mg/kg bw

Remarks on result:

other: no mortalities; test substance: isophorone diisocyanate homopolymer, 70 % solution in 2:1 xylene/2-ethoxyethyl acetate (pH: 6.0)

Mortality:

no mortalities

Clinical signs:

other: 10 minutes post application (p.a.) the animals showed: ataxia, abnormalities in posture, piloerection; 24 hours p.a. and during the observation period no signs of toxicity or treatment related effects were observed anymore.

Gross pathology:

not examined

Other findings:

no other findings

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Conclusions:

The LD50 value (oral) of IPDI homopolymer (approx. 70 % in solvent) in female and male rats was estimated to be > 14000 mg/kg bw.
No mortalities were observed. Clinical signs like ataxia, abnormalities in posture and piloerection were observed beginning 10 min after dosing and lasting 24 hours. Therefore, under the conditions of this study the acute toxicity of IPDI homopolymer after oral exposure in rats is very low.

Executive summary:

In this standard acute method IPDI homopolymer (approx. 70% in solvent) was administered once to 2 dose-groups of Wistar rats (5 male and 5 female rats per dose-group) in doses of 10000 and 20000 mg/kg bw of undiluted test substance. The animals were observed for mortality and any sub-lethal effects for 7 days after dosing. No death occurred during the study. Clinical signs like ataxia, abnormalities in posture and piloerection were observed beginning 10 min after dosing and lasting 24 hours. According to this study the LD50 value (oral) was determined to be > 14000 mg/kg bw. Therefore under the conditions of this study the acute toxicity of IPDI homopolymer after oral application in rats is very low.