3,5-DIMETHOXY-4-(1-METHYLPROPOXY)BENZALDEHYDE

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 January to 03 February 2004

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:

2004

Report date:

2004

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:

4-(butan-2-yloxy)-3,5-dimethoxybenzaldehyde

EC Number:

607-081-7

Cas Number:

224586-49-6

Molecular formula:

C13H18O4

IUPAC Name:

4-(butan-2-yloxy)-3,5-dimethoxybenzaldehyde

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): v175023
- Physical state: brown liquid
- Analytical purity: 99.05%
- Lot/batch No.: v175023/P8B
- Expiration date of the lot/batch: 15 Dec 2004
- Storage condition of test material: at room temperature protected from light

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 8 weeks
- Weight at study initiation: 159-195 g
- Fasting period before study: 20 hours (+ 3-4 hours after administration of the substance)
- Housing: 3 animals in Macrolon cages (type IV height 18 cm) with purified sawdust bedding material
- Diet: pelleted laboratory animal diet (Altromin (VRF1), Lage, Germany) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6-20.8°C
- Humidity (%): 34-80%
- 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: 1.744 mL/kg (2000 mg/kg bw); 0.262 ml/kg (300 mg/kg bw)

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

Doses:

2000 mg/kg bw and 300 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:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

2 females at 2000 mg/kg bw on day 1
none at the two trials at 300 mg/kg bw

Clinical signs:

other: At 2000 mg/kg bw tremor, lethargy, hunched posture, ventro-lateral recumbency, piloerection, shallow respiration, ptosis, flat gait, uncoordinated movements in females that died tremor, lethargy, hunched posture, shallow respiration, piloerection, ptosis,

Gross pathology:

no findings in survivors
abnormalities of the glanduar mucosa (red foci, crateriform retraction) in animals that died

Any other information on results incl. tables

It is not clear from the report whether the animals at 2000 mg/kg bw were found dead or were killed in extremis.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is between 300 and 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 and 300 mg/kg bw. In the first trial at 2000 mg/kg bw 2 females died on day 1 (showing abnormalities of the glandular mucosis). In the second and third trial no mortality was observed. Clinical signs in surviving animals consisted of among others of tremor, hunched posture and/or uncoordinated movements (day 1 and 2). No effects on bodyweight and no macroscopic abnormalites were found in surviving animals. The LD50 is between 300 and 2000 mg/kg bw.