Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Reaction mass of Carbamic acid, N-(5-isocyanato-2-methylphenyl)-, 2-ethylhexyl ester and Carbamic acid, N-(3-isocyanato-4-methylphenyl)-, 2-ethylhexyl ester and N,N'-(4-Methyl-1,3-phenylene)bis(carbamic acid) C,C'-bis(2-ethylhexyl) ester (EC: 937-955-6) Read-across data:

Acute toxicity: oral - LD50 was >5.0 mL/kg.

Acute toxicity: dermal - LD50 > 2.0 mL/kg; undiluted

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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: The study was performed to a recognised guideline in accordance with generally accepted scientific principles.
Qualifier:
according to guideline
Guideline:
other: Standard (FHSA) Procedures.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
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.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Not specified
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
Details on study design:
Not specified
Statistics:
LD50 was calculated by probit transformation based on 14 days of observation.
Key result
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.
Other findings:
No other findings specified.
Interpretation of results:
GHS criteria not met
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
K2 - only study available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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: The study was performed to a recognised guideline in accordance with generally accepted scientific principles.
Qualifier:
equivalent or similar to guideline
Guideline:
other: I.R.L.G. Guidelines method
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
Two rabbits per sex were dosed on the dorsal area (240 cm2) abraded and dosed at 2.0 mL/kg undiluted material. Covered with porous gauze dressing and a semi-occlusive wrapping of polyethylene. Rabbits restrained in hood facing outward for 24-hour contact period to avoid their inhaling any volatiles. The IRLG guidelines recommend a semi-occlusive sheeting and no immobilisation during the contact period.
The animals were observed for 14 days.
GLP compliance:
not specified
Test type:
other:
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Diet (e.g. ad libitum): Appropriate Wayne diet ad libitum.
- Water (e.g. ad libitum): ad libitum.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 240cm^2
- Type of wrap if used: porous gauze dressing covered by a semi occlusive polyethylene wrapping

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2mL/kg

VEHICLE
N/A
Duration of exposure:
24 hours.
Doses:
2.0 mL/kg.
No. of animals per sex per dose:
2 animals per sex per dose.
Control animals:
no
Details on study design:
Dorsal area (240 cm2) abraded and dosed at 2.0 mL/kg undiluted material. Covered with porous gauze dressing and a semi-occlusive wrapping of polyethylene. Rabbits restrained in hood facing outward for 24-hour contact period to avoid their inhaling any volatiles.
The animals were observed for 14 days.

LD50 was calculated by probit transformation based on 14 days of observation.
Observations were made during this time to assess skin reactions and bodyweight changes.
At the end of the observation period, animals were necropsied.
Statistics:
Not reported
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Remarks on result:
other: 95%CL not reported
Mortality:
No deaths occured during the study.
Clinical signs:
other: Skin damage caused by the manipulative trauma of removing the gauze and sheeting at 24 hours. Scabbing over of skin injuries at 48 hours. Soft stool noted on various days throughout the 14-day observation period.
Gross pathology:
Rough edges on liver (2 females); spleen injected (1 female); upper right lung lobe dark red after washing (1 male)
Interpretation of results:
GHS criteria not met
Conclusions:
The LD 50 of the substance was determined to be >2.0 mL/kg; undiluted.
Executive summary:

The skin penetration of the test material was investigated in a single dose in accordance with Modified I.R.L.G. Guidelines method. (1979).

Two rabbits per sex dosed on abraded skin at 2.0 mL/kg of the undiluted material had moderate to marked capillary injection as a result of the 24-hour application under semi-occlusive polyethylene sheeting. At the end of the 14-day observation period, all animals had gained weight. No mortality was seen.

LD50 > 2.0 mL/kg; undiluted

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
K2 - only study available

Additional information

Acute toxicity: oral

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 (5000 mg/kg bw).

Acute toxicity: dermal

Two rabbits per sex dosed on abraded skin at 2.0 mL/kg of the undiluted material had moderate to marked capillary injection as a result of the 24-hour application under semi-occlusive polyethylene sheeting. At the end of the 14-day observation period, all animals had gained weight. No mortality was seen.

LD50 > 2.0 mL/kg; undiluted (2000 mg/kg bw).

Justification for classification or non-classification

According to Regulation (EC) 1272/2008 table 3.1.1, the test substance does not require classifying as acutely toxic via the oral or dermal route based on the data obtained from the read-across substance.