3-(4-tert-butylphenyl)propionaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was administered to male and female rats by gavage in single doses of 2.4, 2.9, 3.2 or 4.2 mL per kg bw. After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after wich autopsies were carried out on survivors and the LD 50 was calculated.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(4-tert-butylphenyl)propionaldehyde

EC Number:

242-016-2

EC Name:

3-(4-tert-butylphenyl)propionaldehyde

Cas Number:

18127-01-0

Molecular formula:

C13H18O

IUPAC Name:

3-(4-tert-butylphenyl)propanal

Constituent 2

Reference substance name:

Bourgeonal

IUPAC Name:

Bourgeonal

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Bourgeonal
- Physical state: Colourless liquid
- Lot/batch No.: V-02759

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, Netherlands.
- Age at study initiation: Young adult, age not specified.
- Weight at study initiation: Males 200 to 260 g, females from 100 to 134 g.
- Fasting period before study: Overnight
- Diet (e.g. ad libitum): Stock diet available ad libitum
- Water (e.g. ad libitum): Ad libitum
- Housing: In groups of 5 in stainless-steel cages with grid-bottom and front.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1 °C
- Air changes (per hr): Well ventilated, but air changes not specified.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2.4, 2.9, 3.5 or 4.2 mL/kg bw

No. of animals per sex per dose:

Five/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: Observed for signs of intoxication.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2.66 mL/kg bw

Based on:

test mat.

95% CL:

2.43 - 2.91

Mortality:

Deaths occurred between 7 h and 3 days after dosing. Then the survivors recovered gradually and looked quite healthy at the end of the observation period.

Clinical signs:

other: Within a few hours after treatment the rats showed sedation and signs of ataxia. Later, signs of emaciation, encrustations around eyes and nostrils and coma were frequently observed.

Gross pathology:

Macroscopic examination of the survivors did not reveal any treatment-related gross alterations.

Any other information on results incl. tables

Doses applied and mortality figures:

Dose (mL/kg)	Mortality
	Number		Percent
	Males	Females
2.4	2/5	1/5	30
2.9	3/5	4/5	70
3.5	4/5	5/5	90
4.2	5/5	5/5	100

Applicant's summary and conclusion

Conclusions:

The test substance was assessed for acute oral toxicity in rats using a single dose administered by oral gavage. The LD50 was calculated to be 2.66 mL/kg bw with 95% confidence limits of 2.43 and 2.9 mL/kg bw.