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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
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). 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:
no
Remarks:
; GLP was not compulsory at the time the study was conducted
Test type:
other: Inhalation hazard test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- 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
Vehicle:
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:
no
Duration of exposure:
7 h
Concentrations:
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:
no
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
Statistics:
no

Results and discussion

Preliminary study:
no data
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.41 mg/L air
Exp. duration:
7 h
Remarks on result:
other: All 12 animals exposed to the test material survived.
Mortality:
All animals exposed to the test material survived, as well as all controls.
Clinical signs:
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 of necropsy.
Controls were inconspicuous.
Body weight:
Only initial body weights were recorded.
Gross pathology:
Necropsy of the animals sacrificed on day 14 was inconspicuous.
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results, the LC50 is considered to be higher 0.41 mg/L.
Executive summary:
Sprague Dawley rats were exposed to atmosphere saturated with the volatile parts of the test material Hexamethylene Diacrylate (technical grade, purity ca. 90%) at 20 °C for 7 hours. The test concentration was 0.41 mg/l air. All 12 animals survived. Clinical symptoms consisted of accelerated intermittent breathing, snout-wiping and unkempt fur and were seen during and after exposure for 3 days, the symptoms were indicative for respiratory irritation. Necropsy of the animals sacrificed on day 14 was inconspicuous.