2-methyl-3-(p-tolyl)propionaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 25, 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

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:

2-methyl-3-(p-tolyl)propionaldehyde

EC Number:

255-410-4

EC Name:

2-methyl-3-(p-tolyl)propionaldehyde

Cas Number:

41496-43-9

Molecular formula:

C11H14O

IUPAC Name:

2-methyl-3-(4-methylphenyl)propanal

Test material form:

liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

3.2, 4.0, 5.0 and 6.25 g/kg

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Statistics:

Not performed

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 100 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 500 - <= 4 800

Mortality:

Death occurred between the day 0 and 2nd day after treatment at all doses.
See the table of results below.

Clinical signs:

other: Toxic signs: - 3.2 g/kg: lethargy and coma in 1 each - 4.0 g/kg: lethargy, coma - 5.0 g/kg: lethargy, coma, ataxia, ptosis - 6.25 g/kg: ataxia, lethargy, flaccid

Gross pathology:

Some effects were reported on the lungs (dark and orange areas at all doses), liver (dark, mottled or white areas at all doses), kidney (dark, mottled or white areas at all doses except the higher one), intestines (red, yellow or grey, bloated areas at all doses), stomach (dark or bloated at all doses except the higher one), bladder (bloated at 4 g/kg only).

Any other information on results incl. tables

Results

Doses g/kg	Mortality	Day of death: 0	Day of death: 1	Day of death: 2	Day of death: 3	Day of death: 7
3.2	2/10	n/a	2	n/a	n/a	n/a
4.0	6/10	n/a	5	1	n/a	n/a
5.0	6/10	1	1	4	n/a	n/a
6.25	10/10	n/a	9	1	n/a	n/a

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the test conditions of this study, the oral LD50 of the test substance in rats was estimated to be equal to 4100 mg/kg bw.
Therefore, the test material is classified Category 5 (H303: May be harmful if swallowed) according to the GHS, as the LD50 value is comprised between 2000 and 5000 mg/kg bw, and is not classified according to the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity study equivalent to the OECD test guideline No. 401, ten rats per dose were given the following dose level: 3200, 4000, 5000 and 6250 mg test material/kg bw.

Mortality and toxic signs were monitored during the study.

 Death occurred between day 0 and the day 2 after treatment. Signs of coma, ataxia and lethargy were frequently observed. 

 Oral LD50 = 4100 mg/kg bw

The LD50 of the test substance to rats (sex unspecified) was found to be 4100 mg/kg bw, with a 95% confidence limits between 3500 - 4800.
Considering the relative density of the substance, the oral LD50 of the test substance to rats was estimated to be equal to 4100 mg/kg bw.Therefore, the test material is classified Category 5 (H303: May be harmful if swallowed) according to the GHS, as the LD50 value is comprised between 2000 and 5000 mg/kg bw, and is not classified according to the Regulation (EC) No. 1272/2008 (CLP).