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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
In principle, the methods described in OECD Guideline 401 were used.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Methyl-2-butenal
- Analytical purity: ca. 98%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Weight at study initiation: mean group body weight range: males 190-260 g; females 160-190 g
- Fasting period before study: 15-20 hrs
- Diet: Herilan MRH-Haltung; Eggersmann KG
- Water: ad libitum



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 3.16; 4.64; 5.62; 6.81; 8.25; 10.00 %

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
316, 464, 562, 681, 825, 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 0, 15, 30 min, 1, 2, 4, 5 hours, day 1, daily thereafter on working days
- Frequency of weighing: day 0, 4 (except 562 mg/kg dosing group: weighing on day 3), 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Model of Dose-Response-Relationship: F (P) = A+B* LN (D) with: D=dose; P=frequency of occurrence of death animals upon treatment with D; F= inverse function of the cumulative standardised normal distribution; LN=natural logarithm ; A+B= parameters of the model;

Test on homogeneity: chi-square test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
690 mg/kg bw
Mortality:
Deaths occurred within 1 hr at 1000 mg/kg bw and 681 mg/kg bw or within 1 d after doses of 562, 681, 825 mg/kg bw. Mortalities were as follows: 0/10 animals at 316 or 464 mg/kg bw; 2/10 animals at 562 mg/kg bw; 3/10 animals at 681 mg/kg bw; 9/10 animals at 825 mg/kg bw; 10/10 animals at 1000 mg/kg bw.
Clinical signs:
dyspnoea; gasping; apathia; abnormal lateral position; staggering; tremor; muscle-twitching; spastic movement; saltation convulsions; trismus; tonic convulsions; scrubby coat; erythema; cyanosis; salivation; lacrimation; disturbance of equilibrium; poor general condition
Body weight:
no data






Gross pathology:
deceased animals: heart: acute dilatation (both organ sites), acute congestive hyperemia; liver: peripheral injections of liver lobes (peripheral lobular pattern); stomach: proventriculus reddened; gastroesophageal vestibule:enhanced intravascular injection;
sacrificed animals: Stomach: esophageal vestibule wall thickened; development of gnathions; local adhesions of esophageal vestibule with liver, peritoneum and spleen

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU