Registration Dossier
Registration Dossier
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EC number: 203-527-6 | CAS number: 107-86-8
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: comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-methyl-2-butenal
- EC Number:
- 203-527-6
- EC Name:
- 3-methyl-2-butenal
- Cas Number:
- 107-86-8
- Molecular formula:
- C5H8O
- IUPAC Name:
- 3-methyl-2-butenal
- Details on test material:
- - Name of test material (as cited in study report): Dimethylacrolein, Substance-No. 78/452
- Analytical purity: 98 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 185 +/- 15
- Diet: Herilan MRH ad libitum
- Water ad libitum
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body inhalation system
- Exposure chamber volume: 200 l
- Source and rate of air: 200 l/hour
- Temperature, pressure in air chamber: 20°C, 761-763mbar - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0.97, 3.15, 3.59, 3.88, 6.08 mg/l (970, 3150, 3590, 3880, 6080 mg/m³)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: at study initiation, on day 7 and 14
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- Probit-Analysis according to Finney (p. 1-150, Cambridge Univerity Press, 1971)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 3.7 mg/L air
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 14.8 mg/L air
- Exp. duration:
- 1 h
- Remarks on result:
- other: calculated according to Haber's rule: c*t=k
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 3.5 mg/L air
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 4 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Dose Dead animals/out of total
0.97 mg/l 0/20
3.15 mg/l 0/20
3.59 mg/l 9/20
3.88 mg/l 13/20
6.08 mg/l 20/20 - Clinical signs:
- other: Animals from the 2 lowest dose groups recovered within 5 days from signs which included lacrimation and nasal discharges, closed lids, labored breathing, unkept fur. Signs were more pronounced in animals receiving higher doses and included dyspnoea, un
- Body weight:
- Mean group body weights were reduced in a dose-dependent manner in both sexes 7 days after dosing. 14 days after dosing body weights of female survivors were not different from controls. This applies also to the male animals except for the 3.88 dosing group. Mean body weight of this group was reduced by approx. 11% when compared with control animals.
- Gross pathology:
- animals that died: acute heart dilatation in atrei and acute congestion. Several victims showed peripheral lobular pattern in liver and edematous lungs. sacrificed animals: nothing abnormal detected
Any other information on results incl. tables
Mean body weight |
day 0 |
day 7 |
day 14 |
|||
male |
female |
male |
female |
male |
female |
|
control weight (g) number of animals |
0 10 |
0 10 |
+44 10 |
+19 10 |
+72 10 |
+32 10 |
Group 1 weight (g) number of animals |
- |
- |
- |
- |
- |
- |
Group 2 weight (g) number of animals |
0 10 |
0 10 |
-8 1 |
-15 6 |
+51 1 |
+29 6 |
Group 3 weight (g) number of animals |
0 10 |
0 10 |
-2 3 |
+9 8 |
+60 3 |
+36 8 |
Group 4 weight (g) number of animals |
0 10 |
0 10 |
+26 10 |
+17 10 |
+66 10 |
+19 10 |
Group 5 weight (g) number of animals |
0 10 |
0 10 |
+43 10 |
+18 10 |
+83 10 |
+31 10 |
Combined male and female LC50 was 3.7 mg/l (3700 mg/m3). LC50 was comparable in males and females (LC50 males 3.5 mg/l, LC50 females 4.0 mg/l).
Symptoms persisted until the end of the 14 day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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