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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: According to guideline (84/449/EEC) with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC (Gazette of the European Community, No. L 251, of 19 Sept, 1984, page 96)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methylenediphenyl diisocyanate
EC Number:
247-714-0
EC Name:
Methylenediphenyl diisocyanate
Cas Number:
26447-40-5
Molecular formula:
C15H10N2O2
IUPAC Name:
1,1'-methylenebis(2-isocyanatobenzene)
Constituent 2
Reference substance name:
Benzene, 1,1'-Methylenbis(isocyanato)-
IUPAC Name:
Benzene, 1,1'-Methylenbis(isocyanato)-
Details on test material:
- Name of test material (as cited in study report): Desmodur VP PU 1806
- Substance type: reddish liquid
- Physical state: 99.96%
- Expiration date of the lot/batch: 01 Nov 1990
- Storage condition of test material: 4 °C, under N2

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: males 8 weeks and females 10 weeks
- Mean body weight at study initiation: males 184 g and females 167 g
- Fasting period before study: About 16 hours before and up to 4 hours after application
- Housing: groups of 5 per cage
- Diet (e.g. ad libitum): standard diet Altromin 1324 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
DOSAGE PREPARATION
The substance was dissolved in Peanut oil on a magnetic stirrer at room temperature. It was administered at a constant application volume of 10 ml/kg bw. The test substance was formulated in the application medium immediately before administration.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and clinical signs were observed several times on the day of administration and twice daily thereafter. Animals were weighed before administration and weekly thereafter.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities were observed
Clinical signs:
other: All animals had increased salivation 30 min after application. One hr after application, all animals were free of clinical signs.
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion