3,5-dimethoxy-4-propoxybenzaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 May to 19 June 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,5-dimethoxy-4-propoxybenzaldehyde

EC Number:

620-249-4

Cas Number:

39075-26-8

Molecular formula:

C12 H16 O4

IUPAC Name:

3,5-dimethoxy-4-propoxybenzaldehyde

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): v59442
- Molecular formula (if other than submission substance):
- Physical state: light yellow brown solid
- Analytical purity: > 94%
- Lot/batch No.: v59442/F2A
- Expiration date of the lot/batch: 01 May 2008
- Storage condition of test material: at room temperature in the dark
- Other: melting at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sultzfeld, Germany
- Age at study initiation: ca 10 weeks
- Weight at study initiation: 195-229 g
- Fasting period before study: 20 hours (+ 3-4 hours after administration of the substance)
- Housing: 3 animals in Macrolon cages (MIV type height 11 cm) with sterilised sawdust bedding material and paper as cage enrichment
- Diet: pelleted rodent diet (SM R/M-Z, SNIFF Spezialdiäten, Soest, Germany) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-22.7°C
- Humidity (%): 39-83%
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.742 mL

DOSAGE PREPARATION (if unusual): The substance was heated in a water bath at maximum 39 °C during maximum 30 minutes

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not indicated

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs on periodic intervals during day 1 and daily thereafter
- Frequency of weighing: on day 1 (before treatment), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopy

Statistics:

NA

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1 female at first trial at 2000 mg/kg bw on day 1
none at the second trial at 2000 mg/kg bw

Clinical signs:

other: tremor, hunched posture and/or uncoordinated movements on day 1 and 2 in surviving animals. clonic spasms, tremor, ventro-lateral recumbency, pale appearance and shallow respiration in the female that died

Gross pathology:

no findings

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is > 2000 mg/kg bw

Executive summary:

The substance was tested with the acute toxic class method in female rats (3/group) treated at 2000 mg/kg bw. In the first trial 1 female died on day 1. In the second trial no mortality was observed. Clinical signs in surviving animals consisted of tremor, hunched posture and/or uncoordinated movements (day 1 and 2). No effects on bodyweight and no macroscopic abnormalites were found. The LD50 is > 2000 mg/kg bw.