Isovaleraldehyde

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 with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

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:

Internal BASF method was used which was in large part equivalent to OECD guideline 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isovaleraldehyde

EC Number:

209-691-5

EC Name:

Isovaleraldehyde

Cas Number:

590-86-3

Molecular formula:

C5H10O

IUPAC Name:

3-methylbutanal

Details on test material:

- Name of test material (as cited in study report): Isovaleraldehyde, 3-Methylbutanal

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Weight at study initiation: mean 172 g (male), 166 g (female)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous emulsion in carboxymethylcellulose with 2-3 drops of Cremophor EL

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2, 16, 30%
- Amount of vehicle (if gavage): 10, 21.4, 26.6, 33.3 mL/kg

Doses:

200, 1600, 3200, 6400, 8000, 10000 µl/kg bw (159, 1275, 2550, 5101, 6376, 7970 mg/kg bw based on a density of 0.797 g/cm3)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of weighing: prior to study, day 3-4 and day 7
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 740 mg/kg bw

Remarks on result:

other: LD50 converted from the originally reported value of 7.2 mL/kg bw (based on a density of 0.797 g/cm³

Mortality:

6400 µl/kg bw (5100 mg/kg bw ): 1/5 females within 24 h; 2/5 females within 48 h
8000 µl/kg bw (6376 mg/kg bw): 5/5 females within 24 h; 1/5 male within 24 h
10000 µl/kg bw (7970 mg/kg bw): 4/5 females within 1 h; 5/5 females within 24 h; 1/5 male within 1 h; 4/5 males within 24 h

no mortality in other groups

Clinical signs:

other: staggering, partly creeping movement, lateral and dorsal positioning, apathy, atony, exsiccosis

Gross pathology:

adhesion of the stomach with the peritoneum, liver and spleen, gastroesophageal vestibule and mucosa thickened with button-like hyperplasia of the mucosa

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of isovaleraldehyde was determined to be 5740 mg/kg bw. No classification is required according to EU legislation.

Executive summary:

The acute oral toxicity of isovaleraldehyde was determined in groups of 5 male and 5 female Sprague-Dawley rats receiving the test material by oral gavage at doses of 160, 1275, 2550, 5100, 6376, and 7970 mg/kg bw. The observation period was 14 days. The LD50 was estimated using a graphical evaluation of the dose response curve on probability paper. Overall, the study was conducted in accordance with the recently retracted OECD test guideline 401.

 

The acute oral LD50 was determined to be 5740 mg/kg bw in rats (BASF, 1974).