4-hydroxybutyl acrylate

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:

comparable to guideline study with acceptable restrictions

Remarks:

Restrictions: limited documentation, no analytical monitoring of test atmosphere concentration

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

no analytical monitoring of test atmosphere concentration; 7-days observation period

Principles of method if other than guideline:

BASF Test: This test (also called inhalation hazard test) was performed in principle as described in OECD Guideline 403 (1981). It demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation. Young adult laboratory rats were purchased from a breeder. Groups of 3 rats per sex were exposed sequentially to the vapours, 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 a time period of 8 hours at 20 °C. The exposure time not causing lethality was tested twice. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with the volatile components of the test substance.

GLP compliance:

no

Test type:

other: Inhalation Hazard Test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxybutyl acrylate

EC Number:

219-606-3

EC Name:

4-hydroxybutyl acrylate

Cas Number:

2478-10-6

Molecular formula:

C7H12O3

IUPAC Name:

4-hydroxybutyl acrylate

Specific details on test material used for the study:

- Name of test material: Butanediol-(1,4)-monoacrylate
- Analytical purity: approx. 95 - 98 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean body weight at study initiation (mean of 3 animals):
- males: 198 (test group 1), 193 (test group 2), and 206 (control group) g;
- females: 169 (test group 1), 164 (test group 2), and 169 (control group) g

ENVIRONMENTAL CONDITIONS
no details given

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

approx. 0.17 mg/L (saturated atmosphere)
Calculated vapour saturation: based on the vapour pressure and molecular weight of the test substance, the vapour saturation was calculated to be 0.06 mg/L at 25 °C.

No. of animals per sex per dose:

3 animals/sex/dose group (two groups) = in total 6 animals/sex/dose
3 animals/sex/control group

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily on workdays; group-wise determination of body weights at test start and termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

0.17 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: This corresponds to 170 mg/m3.

Mortality:

No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.

Clinical signs:

other: No clinical signs of toxicity were noted.

Body weight:

Body weights at test termination:
- males: 236 (test group 1), 214 (test group 2), and 263 (control group) g;
- females: 188 (test group 1), 172 (test group 2), and 181 (control group) g

Gross pathology:

At necropsy no gross-pathological findings were recorded.

Any other information on results incl. tables

The test substance concentration was estimated to be approx. 0.17 mg/L at 20 °C. Vapour saturation was calculated to be approx. 0.06 mg/L at 25 °C. Concentrations above the vapour saturation treshold should carefully be considered to be aerosols. Thus, the animals were exposed to a saturated vapour atmosphere, possibly in the presence of some aerosol particles.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met