3-phenylbutyraldehyde

Endpoint summary

Description of key information

Acute Toxicity (oral, rat, OECD 401): > 2000 mg/kg bw
Acute Toxicity (dermal): data lacking
Acute Toxicity (inhalation): data lacking

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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.

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

Preliminary study:

not applicable

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The information is reliable and consistent with the database as a whole.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The potential acute oral toxicity of the substance was evaluated in male and female rats in a GLP-compliant study conducted according to the OECD Guideline for the Testing of Chemicals No. 401 (Toxicol Laboratories, 1989). Aside from an animal that was mis-dosed into the lungs, there were no deaths on study following oral gavage of the substance and an observation period of 14 days. It was concluded that the test material had an LD50 of greater than 2,000 mg/kg body weight.

 

No data on the acute dermal or inhalation toxicity were identified.

Justification for selection of acute toxicity – oral endpoint
Klimisch 1 study according to guideline study

Justification for classification or non-classification

Acute Toxicity, oral: the substance has an acute oral LD50 of greater 2,000 mg/kg body weight. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.1.

 

Acute Toxicity, dermal: there is no information available concerning dermal toxicity; data are lacking.

 

Acute Toxicity, inhalation: there is no information available concerning inhalation toxicity; data are lacking.

While effects were noted during necropsy in the acute oral study, the findings are not toxicologically relevant and do not indicate significant changes indicating functional disturbance or morphological changes. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.8 Specific Organ Toxicity - Single Exposure (STOT-SE).