Oxybis(methyl-2,1-ethanediyl) diacrylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Principles of method if other than guideline:

BASF-Test
The inhalation hazard test demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (usually 20°C). Groups of rats were sequentially exposed to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted disc in a glass cylinder for different time periods.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of the test substance weight loss during exposure. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.

GLP compliance:

not specified

Test type:

other: Inhalation Risk Test

Test material

Test material information

Constituent 1

Reference substance name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

EC Number:

256-032-2

EC Name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Cas Number:

42978-66-5

Molecular formula:

C15 H24 O6

IUPAC Name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga, Sulzfeld, Germany
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 180 - 250 g
- Housing: 3 animals per cage in Becker D III cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 2°C
- Humidity (%): 50+-5 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

see: any other informations on materials and methods

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

The dose, based on the a vapor pressure of ca. 0.000044 hPa at 20 °C, computes to ca. 0.00054 mg/l.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were checked daily for clinical signs
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross-pathology

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

0.001 mg/L air

Exp. duration:

7 h

Remarks on result:

other: All 12 animals exposed to the test material survived.

Mortality:

no deaths, all 12 animals survived the 14 days post exposure

Clinical signs:

other: wiping of the snout

Body weight:

no data

Gross pathology:

without findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All 12 animals survived the inhalation risk test, where the animals were exposed to a saturated vapor of the test substance (concentration ca. 0.00045 mg/l) for 7 hours.

Executive summary:

The acute inhalation toxicity was investigated in an Inhalation Risk test with rats (reliability 2). The test was performed in principle as described in OECD test guideline 403 (GLP not specified). It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20 °C. Young adult laboratory rats, 6 per sex, were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 7 hours. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as 0.000545 mg/l based on the vapor pressure. Group-wise documentation of clinical signs was performed over a 14 day study period. All animals survided inhalative exposure and showed no gross pathology findings. Clinical symptoms soley included wiping of the snout throughout expsoure.

Based on the study findings no acute inhalation toxicity can be concluded for animals expsosed to a saturated vapor of the test item.