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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Small number of animals investigated, 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 applied in increasing doses at increments of o.2 fractional log intervals to the closely clipprd, intact skin of New Zealand White male and female rabbits. The treated areas were covered with plastic strips and the animals held in wooden stocks for periods up to 24 hours, after which time they were assigned to individual cages. Observations were made for toxic signs during a 14-day period after dosing and the viscera of the test animals were examined macroscopically.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

75880-28-3

Cas Number:

75880-28-3

IUPAC Name:

75880-28-3

Specific details on test material used for the study:

name of test substance Mondur PF

Test animals

Species:

rabbit

Strain:

New Zealand White

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: 1.8 - 2.3 kg
- 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no data
- % coverage: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

5010, 7940 mg/kg

No. of animals per sex per dose:

1 male (5010 mg/kg); 1 male and 1 female (7940 mg/kg)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes (viscera only)
- Other examinations performed: clinical signs, body weight

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 940 mg/kg bw

Mortality:

All three animals survived the treatment with 5010 and 7940 mg/kg bw.

Clinical signs:

other: Toxic signs included reduced appetite and activity for two to three days.

Gross pathology:

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 dermal toxicity of the test item was low with an LD50 value >7940 mg/kg bw for male and female rabbits. Based on the study results the EU GHS classification criteria were not met.

Executive summary:

The acute dermal toxicity of  the test item was low with an LD50 value > 7940 mg/kg bw for male and female rabbits. Single administration of 7940 mg/kg bw over 24 hours 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.