2,2-dimethylpropane-1,3-diyl dibenzoate

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 described test is performed with essential saturated vapor and not designed to determine a LC50 value.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

5 male and 5 female rats were exposed to essential saturated vapor for 6 hours. The calculated concentration of the vapor in the chamber atmosphere was about 0.16 mg/l (approx. 160 mg/m³). During the following observation time the rats were observed for clinical signs, mortality, body weight development and finally for gross pathological changes after necropsy.

GLP compliance:

no

Test type:

other: test with essential saturated vapor

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diyl dibenzoate

EC Number:

224-081-9

EC Name:

2,2-dimethylpropane-1,3-diyl dibenzoate

Cas Number:

4196-89-8

Molecular formula:

C19H20O4

IUPAC Name:

3-(benzoyloxy)-2,2-dimethylpropyl benzoate

Specific details on test material used for the study:

- yellowish white chunks

Test animals

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males:248-280 g; females: 224-254 g
- Fasting period before study: no
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The rats were maintained in accordance wigh the recommendations contained in H.E.W., Publication No. 74-23 /N.I.H.) entiteled : Guide for the Care and Uses of Laboratory animals

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE (saturated vapor atmosphere):
The vapors of the compound were generated by passing air at the rate of 20 l/min through a round bottom flask containing the compound.
The flask was placed in a heating jacket and heated to 100°C . The vapors emerging from the flask were introduced into the exposure chamber without dilution. The temperature within the exposure chamber was approximately 28°C. The rats were thus exposed to an atmosphere essentially saturated with the vapors of the test material.
The concentration of the vapor (0.16 mg/l) in the chamber atmosphere was calculated from the ratio of the total weight loss of the material in the flask after the exposure (1.13 g) to the total volume of air passing through the flask during the 6 hour period (7200 liters).

TEST ATMOSPHERE:
A constant chamber air flow was maintained by means of a rotary centrifugal air pump located at the exhaust side of the chamber.

no data reported on
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric standard deviation)

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 6 h

Concentrations:

The concentration of the vapor (0.16 mg/l) in the chamber atmosphere was calculated from the ratio of the total weight loss of the material in the flask after the exposure (1.13 g) to the total volume of air passing through the flask during the 6 hour period (7200 liters).

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

5 male and 5 female rats were exposed to essential saturated vapor for 6 hours. The calculated concentration of the vapor in the chamber atmosphere was about 0.16 mg/l (approx. 160 mg/m³). During the following observation time the rats were observed for clinical signs, mortality, body weight development and finally for gross pathological changes after necropsy.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: Saturated vapor concentration

Effect level:

ca. 0.16 mg/L air

Exp. duration:

6 h

Remarks on result:

other: No pathological clinical signs. No death occurred during exposure and during post exposure observation time of 14 days. Except for 2/5 females all rats have gained weight after 14 days. Gross pathology revealed no adverse effects.

Mortality:

No death occurred during exposure and during post exposure observation time of 14 days.

Clinical signs:

other: The immediate response of the rats to the experimental atmosphere was an increase in activity in preening. After several minutes of exposure, this activity decreased. No pathological signs were observed.

Body weight:

Except for 2/5 females all rats have gained weight after 14 days.

Gross pathology:

Gross pathology revealed no adverse effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Five male and 5 female rats were exposed to essential saturated vapor for 6 hours. No death occurred during exposure and during post exposure observation time of 14 days. No pathological signs were observed.

Executive summary:

5 male and 5 female rats were exposed to essential saturated vapor for 6 hours. During the following 14 day observation time the rats were observed for clinical signs, mortality, body weight development and finally for gross pathological changes after necropsy.

The immediate response of the rats to the experimental atmosphere was an increase in activity in preening. After several minutes of exposure, this activity decreased. No pathological signs were observed. No death occurred during exposure and during post exposure observation time of 14 days. Except for 2/5 females all rats have gained weight after 14 days. Gross pathology revealed no adverse effects.

The concentration of the vapor (0.16 mg/l) in the chamber atmosphere was calculated from the ratio of the total weight loss of the material in the flask after the exposure (1.13 g) to the total volume of air passing through the flask during the 6 hour period (7200 liters).