Registration Dossier
Registration Dossier
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EC number: 214-222-2 | CAS number: 1115-20-4
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:
- 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:
- 1 974
- 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 substance name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate
- EC Number:
- 214-222-2
- EC Name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate
- Cas Number:
- 1115-20-4
- Molecular formula:
- C10H20O4
- IUPAC Name:
- 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate
- Details on test material:
- - Name of test material (as cited in study report): Hydroxypivalinsaeureneopentylglykolester (HPN)
- Physical state: solid
no further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system 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:
- other: 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.
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