Reaction mass of 2-ethylhexyl (3-isocyanato-4-methylphenyl)carbamate and 2-ethylhexyl (5-isocyanato-2-methylphenyl)carbamate and 2-ethylhexyl (3-isocyanato-2-methylphenyl)carbamate

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: 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:

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

Test material

Test material information

Constituent 1

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:

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.

Administration / exposure

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

Results and discussion

Effect levels

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)

Applicant's summary and conclusion

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