Registration Dossier

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20 °C. Two groups of young adult laboratory rats (3 per sex per group; a total of 12 animals) 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 8 h. The exposure was subsequently repeated in the same manner. 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 exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period.
GLP compliance:
no
Test type:
other: inhalation hazard test
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-butanediyl diacrylate
EC Number:
213-979-6
EC Name:
1,4-butanediyl diacrylate
Cas Number:
1070-70-8
Molecular formula:
C10H14O4
IUPAC Name:
1,4-butanediyl diacrylate
Details on test material:
- Name of test material (as cited in study report): Butandiol-diacrylat

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Exposure:
12 rats for 8 hours; vapour temperature 20°C; concentration 0.06 mg/L;
Addtionally, rat were exposed to vapour generated at 100°C for 1h (6 rats), 3h (12 rats), and 8h (6 rats). Since a lot of substance was lost due to condensation in the pipes, no concentration estimate can be provided for these groups.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
0.06 mg/L;
No. of animals per sex per dose:
12 animals; 6 male and 6 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.06 mg/L air (nominal)
Exp. duration:
8 h
Remarks on result:
other: no animals died when exposed to saturated vapour for 8 hours (20°C)
Mortality:
Mortality did not occur (0/12 died).
When exposed to a saturated atmosphere generated at 100°C (the animals were exposed at RT), 4/6 died when exposed for 1h, 8/12 when exposed for 3h, and 5/6 when exposed for 8h.
Clinical signs:
other: light mucosa irritation (20°C) The higher concentration achieved when generating the atmosphere at 100°C (despite the significant loss within the pipes) led to severe mucusal irritation, encrusted eyes and nose, dyspnoe, and attempts to escape
Body weight:
- Weight at study initiation: group 1 average weight of the 6 animals: 170.8 g
group 2 average weight of the 6 animals: 167.5 g
- Weight at the end of the study: group 1 average weight of the 6 animals: 164.6 g
group 2 average weight of the 6 animals: 164.3 g
Gross pathology:
nothing abnormal detected (20°C)

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification