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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
study report
Report date:

Materials and methods

Principles of method if other than guideline:
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). Several groups of usually 3 rats per sex 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:
; GLP was not compulsory at the time the study was conducted
Test type:
other: Inhalation hazard test
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethylene diacrylate
EC Number:
EC Name:
Hexamethylene diacrylate
Cas Number:
Molecular formula:
hexane-1,6-diyl bisacrylate
Details on test material:
- Name of test material (as cited in study report): 1,6-Hexanedioldiacrylate
- Physical state: liquid
- Analytical purity: > 90% (technical grade)

Test animals

Details on test animals or test system and environmental conditions:
- Weight at study initiation:
mean body weight, males: 184.2 g in the treated group
mean body weight, males: 200 g in the control group
mean body weight, females: 200 g in the treated group
mean body weight, females: 194 g in the control group
- Diet: Herilan MRH-Haltung; H. Eggersmann KG (ad libitum)
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
other: The animals were exposed to atmosphere saturated with the volatile parts of the test material in the air at 20 °C.
Details on inhalation exposure:
Saturation of the atmosphere was generated by conducting an air stream through a substance layer of 5 cm height.
The rats were exposed to the test atmosphere for 7 hours.
Air flow was 200 l/h in the exposure chamber.
The control animals were shame-exposed.
Analytical verification of test atmosphere concentrations:
Duration of exposure:
7 h
The concentration was 0.41 mg/l (20 °C), the nominal concentration was calculated as quotient of the amount of the test substance weight loss during exposure.
No. of animals per sex per dose:
3 animals per sex per group
Control animals:
Details on study design:
The exposure time not causing lethality was tested twice.
- Duration of post exposure period until necropsy: 14 days
- Frequency of weighing: Test animals were weighed at test initiation only
- Frequency of observations: The animals were observed following exposure after 3 min, 10 min, 30 min, 1 hour, 3 hours, 7 hours and thereafter daily for the first 3 days after test initiation
- Necropsy of survivors performed: yes. The necropsy of the animals was done on day 14 following exposure

Results and discussion

Effect levels
Dose descriptor:
Effect level:
0.41 mg/L air
Exp. duration:
7 h
Remarks on result:
other: All 12 animals exposed to the test material survived.
All animals exposed to the test material survived, as well as all controls.
Clinical signs:
other: In both treated groups, accelerated intermittent breathing, snout-wiping and unkempt fur were reported during and after exposure; at day 3 of observation, no more symptoms were seen. Therefore the animals were no more observed until day 14, i.e. the day o
Body weight:
Only initial body weights were recorded.
Gross pathology:
Necropsy of the animals sacrificed on day 14 was inconspicuous.

Applicant's summary and conclusion