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

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies. This reference does not provide a full report with regard to the methods used in this study. Most basic key information is reported.

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: Modified I.R.L.G. Guidelines method (1979)

GLP compliance:

not specified

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)

Duration of exposure:

24 hours.

Doses:

2.0 mL/kg.

No. of animals per group:

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.

Results and discussion

Signs and symptoms of toxicity:

yes

Remarks:

Soft stool was noted on various days throughout the 14 day observation period.

Dermal irritation:

yes

Remarks:

After 24 hours, moderate to marked capillary injection was seen. At 48 hours, moderate capillary injection was recorded.

Any other information on results incl. tables

Skin damaged caused by the manipulative trauma of removing the gauze and sheeting at 24 hours was seen.

The injuries were seen to scab over at 48 hours.

Gains in bodyweight were seen during 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

Conclusions:

LD50 >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