3-phenylbutyraldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October - November 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

other: Acute Oral Toxicity

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-phenylbutyraldehyde

EC Number:

240-362-9

EC Name:

3-phenylbutyraldehyde

Cas Number:

16251-77-7

Molecular formula:

C10H12O

IUPAC Name:

3-phenylbutanal

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ST 25 C 88
- Physical state: clear liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: 4-7 weeks at arrival
- Weight at study initiation: ca. 160 g
- Fasting period before study: animals were fasted overnight prior to dosing
- Housing: animals were housed in single sex groups of five in grid bottomed polypropylene cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 12-27°C
- Humidity (%): 60 -68%
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was controlled to give an artificial cycle of 12 hour light/12 hours dark per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Five male and five female animals were selected for treatment and weighed, the weight being used to calculate the amount of material to be administered at a dose volume of 10 ml/kg bodyweight. After dosing animals were returned to their cage and permitted access to food.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Five male and five female

Control animals:

no

Details on study design:

- Duration of observation period following administration: All animals were examined at approximately 30 minutes and 1, 2 and 4 hours after dosing and then daily for fourteen consecutive days.

- Frequency of observations and weighing: Any sign of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed on Days 1, 8 and 15.

- Necropsy of survivors performed: yes

- Other examinations performed: At the end of the fourteen day post dose observation period all animals were weighed and then sacrificed by carbon dioxide narcosis. All cadavers were subjected to gross examination including the opening of the thoracic and visceral cavities. The stomach and representative sections of the gastro-intestinal tract were examined.

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male was dead five seconds after dosing. Necropsy findings of pink frothy exudate in the trachea and pink inflated appearance of the lungs substantiated the view that this animal had been dosed into the lungs.

Clinical signs:

other: Hyperactivity was observed in the surviving males immediately after dosing together with hunched posture in two animals. All females exhibited hunched posture at this time. All animals exhibited hunched posture, piloerection and hypoactivity from 30 minut

Gross pathology:

Necropsy showed the following effects on animals.
In male animals, the findings included: white waxy plug in the urethra (2 of 4 males examined), white waxy plug in the bladder (1 of 4 males examined), minimal or moderate dilatation of the kidney pelvis (3 of 4 males examined).
In female animals, the findings included : fluid distension of the uterus (1 of 5 females), minimal dilatation of the kidney pelvis (1 of 5 females).

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Conclusions:

It is concluded that the test material had little toxic effect when administered as a single oral dose of 2,000 mg/kg body weight.

Executive summary:

A GLP-compliant acute oral toxicity study was conducted for the substance in rats at the limit dose of 2,000 mg/kg body weight. The study was conducted according to the OECD Testing Guideline No. 401. The substance was diluted in water prior to dosing at a volume of 10 mL/kg body weight. The single mortality occurred in a male animal and based on the necropsy evaluation was concluded to be due to a dosing error. Clinical signs were observed following dosing and consisted of indications of general malaise (piloerection, hunched posture), however all animals had fully recovered by Day 4 following dosing. All animals gained weight during the 2 -week observation period following dosing and no deaths occurred on study (other than the male that had received a dose into the lungs, causing mortality). Findings at necropsy were not indicative of significant toxicities in any organ. It was concluded that the substance had little toxicity when administered as a single oral dose at the limit dose, thus the LD50 is considered to be greater than 2,000 mg/kg body weight.