1,1'-Methylenebis(4-isocyanatobenzene) and its oligomeric reaction products with [(methylethylene)bis(oxy)]dipropanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short post-observation period (7 days), but meets generally accepted scientific standards; sufficiently documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The undiluted compound was fed by stomach tube to male and female Sprague-Dawley rats in increasing doses at increments of fractional (various) log intervals. Observations were made for toxic signs during a 7-day period after dosing and the viscera of the test animals were examined macroscopically.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

75880-28-3

Cas Number:

75880-28-3

IUPAC Name:

75880-28-3

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 210-330 (males); 225-300 (females)
- Fasting period before study: no data
- Housing: individual
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000, 3160, 5010, 7940, 12600, 15800 mg/kg bw

No. of animals per sex per dose:

2000 mg/kg: 1 female
3160 mg/kg: 1 male
5010 mg/kg: 1 female
7940 mg/kg: 1 male
12600 mg/kg: 1 female
15800 mg/kg: 2 males, 3 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 800 mg/kg bw

Mortality:

All animals survived the treatment with doses up to and including 15800 mg/kg bw.

Clinical signs:

other: Toxic signs included reduced appetite and activity for one day.

Gross pathology:

Surviving animals were sacrificed 7 days after dosing. The viscera appeared normal by macroscopic examination.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of  the test item was low with an LD50 value >15800 mg/kg bw for male and female rats. Based on the study results the EU GHS classification criteria were not met.

Executive summary:

The acute oral toxicity of  the test item was low with an LD50 value >15800 mg/kg bw for male and female rats. Single administration of 15800 mg/kg bw was tolerated without mortality, but transient signs of reduced activity were observed. Based on the test results the test item is assesses as practically non-toxic according to EU GHS 1277/2008 criteria.