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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed to a recognised guideline in accordance with generally accepted scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Standard (FHSA) Procedures.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2-Ethylhexyl N-(5-isocyanato-2-methylphenyl)carbamate and 2-Ethylhexyl N-(3-isocyanato-4-methylphenyl)carbamate and N,N'-(4-Methyl-1,3-phenylene)bis(carbamic acid) C,C'-bis(2-ethylhexyl) ester
EC Number:
937-955-6
Molecular formula:
components with the molecular formulae C25H42N2O4 and C17H24N2O3
IUPAC Name:
Reaction mass of 2-Ethylhexyl N-(5-isocyanato-2-methylphenyl)carbamate and 2-Ethylhexyl N-(3-isocyanato-4-methylphenyl)carbamate and N,N'-(4-Methyl-1,3-phenylene)bis(carbamic acid) C,C'-bis(2-ethylhexyl) ester

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Weight range at initiation was 197 - 252 grams.
- Fasting period before study: fasted for 16 hours.
- Diet (e.g. ad libitum): Wayne diet ad libitum.
- Water (e.g. ad libitum): ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
A single dose of 5.0 mL/kg.
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Statistics:
LD50 was calculated by probit transformation based on 14 days of observation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
There was no mortality
Clinical signs:
other: Yellow mucoid diarrhoea was observed in seven of the ten animals 3 h after dosing. All animals appeared normal for the remainder of the study.
Gross pathology:
Gross necropsy revealed a dilated pelvis of the right kidney in one male rat, but this was not considered to be related to the material dosed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was >5.0 mL/kg (dosed undiluted).
Executive summary:

The test material was administered undiluted to 10 fasted Wistar rats as a single oral gavage dose of 5.0 mL/kg.

Yellow mucoid diarrhoea was seen in all the male animals and two females 3 hours after dosing. No other clinical signs were observed and no mortality occurred.

The LD50 was therefore >5.0 mL/kg.