Registration Dossier
Registration Dossier
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EC number: 201-289-8 | CAS number: 80-54-6
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline standard with acceptable restrictions (no GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- The inhalation hazard test (IHT; synonymous to IRT, inhalation hazard test) was performed in principle in accordance to Smyth et al., 1962 (Am. Ind. Hyg. Ass. J. 23, 95-107). The aim of the test was to demonstrate the toxicity of an atmosphere saturated with vapours of the volatile components of the test substance at a temperature chosen for vapour generation (i.e. 20 °C for the present test substance). The animals were exposed to the test substance for 7 hours (771 mmHg).
- GLP compliance:
- no
- Test type:
- other: Inhalation Hazard Test
- Limit test:
- no
Test material
- Reference substance name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- EC Number:
- 201-289-8
- EC Name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- Cas Number:
- 80-54-6
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-(4-tert-butylphenyl)-2-methylpropanal
- Details on test material:
- Analytical purity: 99%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Body weight at study initiation
- Trial I: Male (3) 255.7 g, female (3) 221g
- Trail II: Male (3) 255.3 g: female (3) 214.3 g
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- The animals inhaled the vapours of the test substance, generated by bubbling 200 l/h air through the substance column of about 5 cm above a fritted glass disc in a glass cylinder.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 7 h
- Concentrations:
- Trial I: 0.18 mg/l
Trial II: 0.1 mg/l - No. of animals per sex per dose:
- Trial I: 3
Trial II: 3 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 24h, 48h and at conclusion
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.18 other: mg/l
- Exp. duration:
- 7 h
- Remarks on result:
- other: no mortalities occured
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs of toxicity were observed
- Gross pathology:
- no organ anomalies were observed
Applicant's summary and conclusion
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