3-(p-methoxyphenyl)-2-methylpropionaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 Nov 1979 to 27 Nov 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

EC Number:

226-749-5

EC Name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

Cas Number:

5462-06-6

Molecular formula:

C11H14O2

IUPAC Name:

3-(4-methoxyphenyl)-2-methylpropanal

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: At least 8 weeks old
- Weight at study initiation: 185 - 376 g
- Fasting period before study: 16 - 20 hours
- Housing: 5/cage in suspended wire mesh cages (20"x10"x7")
- Diet: Fresh purina rat chow was freely available
- Water: Fresh water was freely available
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 21 °C
- The room was reserved exclusively for rodents on acute tests and was kept clean in accordance with the standards of AAALAC.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2.47, 2.94, 3.51, 4.20 and 5.0 g/kg bw

No. of animals per sex per dose:

10 male rats per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Doses were selected at log intervals in an attempt to achieve wo partial kills, and if possible a zero kill and/ or a 100% kill.
- Frequency of observations: The rats were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: no, the animals were not examined for gross pathology.
- Other examinations performed: Mortality, toxicity and pharmacological effects

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 400 - <= 4 600

Mortality:

0/10, 0/10, 4/10, 4/10 and 9/10 animals died in the 14 day observation period after exposure to 2.47, 2.94, 3.51, 4.20, and 5.0 g/kg respectively. The animals died in the first 2 days after exposure.

Clinical signs:

other: 2.47 g/kg: On the day of dosing, lethargy, piloerection, ptosis and flaccid muscle tone were noted in less than half of -the animals. These signs were occasionally noted through Day 4. All animals were normal on Days 5 through 14. 2.94 g/kg: On the day o

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed an LD50 of 4000 mg/kg bw. For GHS the substance needs to be classified as: May be harmful if swallowed (H303).

Executive summary:

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 male rats were administered with 1.73, 2.47, 3.51, 4.2 and 5.0 g/kg bw. 0/10, 0/10, 4/10, 4/10 and 9/10 animals died in the 14 day observation period after exposure to 1.73, 2.47, 3.51, 4.2 and 5.0 g/kg respectively. The following signs of toxicity were commonly noted in all dose groups: lethargy, ptosis, piloerection and flaccid muscle tone. In addition in the dose groups receiving 3.51 and 4.2 g/kg three animals were prostrate and one animal was comatose. Animals were not examined for gross pathology. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be 4000 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful.