Veratraldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted in August 1974.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and the study is non-GLP. However, this did not influence the reliability of the results.

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)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Veratraldehyde

EC Number:

204-373-2

EC Name:

Veratraldehyde

Cas Number:

120-14-9

Molecular formula:

C9H10O3

IUPAC Name:

3,4-dimethoxybenzaldehyde

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

The following doses were used in the study: 1310, 1640, 2050, 2560 and 5000 mg/kg bw.

No. of animals per sex per dose:

10 males/dose

Control animals:

no

Details on study design:

- Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

95% CL:

> 1 840 - < 2 160

Mortality:

The following numbers of animals died during the study, at the doses of:
- 1310 mg/kg bw: 0/10
- 1640 mg/kg bw: 4/10 (2 on day 1 and 2 on day 2)
- 2050 mg/kg bw: 6/10
- 2560 mg/kg bw: 9/10
- 5000 mg/kg bw: 10/10.

Clinical signs:

other: Lethargy was noted in rats at the 3 higher doses.

Other findings:

No other findings were noted.

Applicant's summary and conclusion

Interpretation of results:

other: Classified as Acute Category 4

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

Acute oral toxicity was performed equivalent to the guideline OECD TG 401. The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw. Based on the results of this study, in accordance with EU CLP 1272/2008 criteria, the test substance needs to be classified as Category 4. The test substance needs to be classified according to GHS criteria as Category 4 as well.

Executive summary:

An acute oral toxicity study was performed according to the guideline OECD TG 401. Ten male rats were administered the substance at dose levels of: 1310, 1640, 2050, 2560 and 5000 mg/kg bw. No rat died at the dose of 1310 mg/kg bw, four died at 1640 mg/kg bw, six at 2050 mg/kg bw, nine at 2560 mg/kg bw and ten at 2000 mg/kg bw. The clinical signs observed was lethargy at 3 higher doses. The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw.