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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The reference does not contain complete study data. Furthermore, the test was conducted in accordance with methodology that is no longer considered to be acceptable or appropriate.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

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:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Weight at study initiation: 206 - 240 g
- Diet (e.g. ad libitum):Appropriate Wayne diet, ad libitum.
- Water (e.g. ad libitum): ad libitum.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Two procedures were followed.

Static
Substantially saturated vapour was generated within a 120 litre Plexiglass chamber at 25.3 °C by magnetically stirring 200 grams of sample within a 250 cm surface area bowl and allowing the vapour to evolve for 16 hours prior to insertion of the rats. Six female Wistar rats were inserted into the exposure chamber following the 16 hour vapour generation period and inhaled the resultant vapour for an 8 hour period. Animals are added via a drawer-type self-sealing cage.

Alternate
Six female Wistar rats were inserted simultaneously with 200 grams of sample into a 120 litre exposure chamber at 25.7 °C and inhaled the resultant vapour for an 8 hour period.


The static procedure represents the maximum attainable vapour hazard at circa 25 °C, whereas the alternate is more representative of the worst conditions resulting from roller or brush application in a non-ventilated room.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

No. of animals per sex per dose:

6 animals were exposed in both scenarios.

Control animals:

no

Details on study design:

Signs of distress during the exposure period were noted.
in addition, bodyweight changes were observed for 14 days following exposure. At the end of the observation period, all animals wee necropsied.

Results and discussion

Mortality:

No mortality was observed.

Clinical signs:

other: During the static exposure, signs and symptoms seen included: coordination loss; breathing irregularities; eye irritation and clear exudate; anaesthesia. During the alternate exposure, signs and symptoms seen included: coordination loss; breathing irregul

Body weight:

Weight gains recorded throughout the 14 day observation period were considered normal for rats of this age and sex.

Gross pathology:

Static method: lung congestion seen in 2/6; liver dark and mottled seen in 1/6; endemic hydronephrosis seen in 1/6; nothing remarkable seen in 3/6.
Alternate method: lung congestion seen in 3/6; liver dark and mottled seen in 1/6; spleen dark and enlarged seen in 1/6; endemic hydronephrosis seen in 2/6; nothing remarkable seen in 2/6.

Applicant's summary and conclusion

Conclusions:

Little, if any, toxic hazard other than its sensitising potential is anticipated from the infrequent inhalation of substantially saturated vapour generated at room temperature.

Executive summary:

The inhalation toxicity was investigated in rats. 12 female Wistar rats were exposed in two scenarios.

Static

Substantially saturated vapour was generated within a 120 litre Plexiglass chamber and was allowed to evolve for 16 hours prior to insertion of the rats. Six female Wistar rats were inserted into the exposure chamber following the 16 hour vapour generation period and inhaled the resultant vapour for an 8 hour period. Animals are added via a drawer-type self-sealing cage.

Alternate

Six female Wistar rats were inserted simultaneously with 200 grams of sample into a 120 litre exposure chamber and inhaled the resultant vapour for an 8 hour period.

Clinical signs observed during the exposure included coordination loss, breathing irregularities, eye irritation and anaesthesia.

No mortality occurred.

 

Little, if any, toxic hazard other than its sensitising potential is anticipated from the infrequent inhalation of substantially saturated vapour generated at room temperature.