3-methyl-2-butenal

Acute Toxicity: oral

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

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

Test material information

Constituent 1

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): 3-Methyl-2-butenal
- Analytical purity: ca. 98%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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:

other: 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 g

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