2-methylvaleraldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 2008 - April 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study according to OECD423 (dated 17 December 2001)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

dated 17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

dated August 1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methylvaleraldehyde

EC Number:

204-605-2

EC Name:

2-methylvaleraldehyde

Cas Number:

123-15-9

Molecular formula:

C6H12O

IUPAC Name:

2-methylpentanal

Details on test material:

- Name of test material: "Methylpentanal Roh"

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: Approximately 8 weeks at the time of the test substance administration.
- Weight at study initiation: 180 - 197 g
- Fasting period before administration: yes (the evening before adminstration until 3 hrs afterwards)
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week
- Diet: Ssniff R/M-H maintenance diet for rats and mice (item V1534-3 ), ad libitum
- Water: Tap water from an automatic watering system, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.5 °C (continuous control and recording).
- Humidity (%): Average of 49.39 % (continuous control and recording).
- Air changes (per hr): 12 per hour.
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.

IN-LIFE DATES: From: To: 2008-02-19 to 2008-03-05

Administration / exposure

Route of administration:

oral: gavage

Doses:

2000 mg of the test substance per kg body weight

No. of animals per sex per dose:

2 x 3 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, 7 days p.a., 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations were performed 0.5, 1, 2, 3, 4 and 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

other: No abnormalities were observed during the study period.

Gross pathology:

No animal showed any abnormal finding at the necropsy 14 days p.a.