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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test demonstrates that there is no relevant acute inhalation risk, when handling the substance without extensive dust formation. How ever the tes system is unsuitable concerning information going beyond this statement. Acute inhalation toxicity test with dust enriched atmosphere; 8 h whole body exposure; one estimated dose of 0.04 mg/l.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats are exposed for 8 h in a dust enriched atmosphere, generated by leading the air though an about 5 cm thick substance layer. Post exposure period is 7 days.
GLP compliance:
no
Test type:
other: acute inhalation hazard test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxypivalinsaeureneopentylglykolester (HPN)
- Physical state: solid
no further data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
At initiation the age was unknown and mean weight of males was 174 g and of females 156 g
no further data

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
Dust was generated by bubbling 200 l/h dry air (no CO2) through the solid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder at a temperature of 20°C.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
Estimation of concentration from the amount of TS consumed and the air volume: 0.04 mg/l. No further details.
No. of animals per sex per dose:
6 rats per sex exposed for 8 h. Controls: 3 males and 3 females.
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Weighing: at initiation and at termination
- Necropsy performed of survivors and rats found dead
- Other examinations performed: clinical signs
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.04 mg/L air (nominal)
Exp. duration:
8 h
Remarks on result:
other: dust; estimated concentration
Mortality:
No mortality
Clinical signs:
No clinical signs
Body weight:
Normal; compared to controls
Gross pathology:
No effects detected.
Other findings:
No effects in controls exposed to air.

Any other information on results incl. tables

Authors estimation of the exposure concentration presumably via measurement of test substance weight.

Applicant's summary and conclusion

Conclusions:
In the inhalation hazard test no effects were detected in male and female rats after exposure to dust for 8 h at 20°C.
Executive summary:

The acute inhalation toxicity test is an unsuitable test system due to the atmosphere generation, the estimation of the exposure concentration, the exposure time and the short post exposure observation period.

Rats were exposed for 8 h to dust generated at 20°C (estimated concentration: 0.04 mg/l). The mortality rate was 0/6 in males and 0/6 in females. No clinical signs were observed during and after exposure. Necropsy after 7 days revealed no treatment related effects.

Conclusion: In the inhalation hazard test no effects were detected in male and female rats after exposure to dust for 8 h at 20°C.