Aluminium tribenzoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

The experimental data summarized here are evaluated by the WHO and therefore considered reliable, although details on experimental set-up are not included in the evaluation.

Data source

Reference

Reference Type:

review article or handbook

Title:

Benzoic acid and sodium benzoate

Author:

Wibbertmann A Dr. et al.

Year:

2005

Bibliographic source:

WHO CICAD 26

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Ten rats per sex per group were exposed to 0, 25, 250, or 1200 mg benzoic acid dust aerosol/m3 for 6 h per day and 5 days per week over 4 weeks. In the highest dose group, one rat per sex died. Based on this data, it can be concluded that the acute LD50 after a single exposure exceeds 1200 mg/m3.

GLP compliance:

no

Remarks:

Study performed before GLP principles were implemented

Test type:

other: 4 week repeated inhalation exposure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid

EC Number:

200-618-2

EC Name:

Benzoic acid

Cas Number:

65-85-0

Molecular formula:

C7H6O2

IUPAC Name:

benzoic acid

Test animals

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

No experimental details included.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

not specified

Mass median aerodynamic diameter (MMAD):

4.7 µm

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 6 h

Remarks on duration:

Rats were exposed for 6 hours per day and 5 days per week over a period of 4 weeks.

Concentrations:

25, 250, or 1200 mg benzoic acid dust aerosol/m3

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

After the exposure period, various serum biochemical, haematological, organ weight, and histopathological examinations were conducted.
Mortality and body weight were monitored.

Statistics:

Not performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 200 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: See remark

Remarks:

Rats were exposed for 6 hours per day and 5 days per week over a period of 4 weeks.

Mortality:

In the highest dose group, one rat per sex died.

Clinical signs:

other: Not incuded in the evaluation.

Body weight:

The body weight gain was significantly decreased in males and females in the highest dose group compared with controls.

Other findings:

At 25 mg/m3, an increased incidence of interstitial inflammatory cell infiltrate and interstitial fibrosis in the trachea and lungs in treated animals compared with controls was seen. Although the number of these microscopic lesions was higher in treated animals than in controls, there was no clear dose dependency for this effect. A concentration of 250 mg/m3 resulted in upper respiratory tract irritation, as indicated by inflammatory exudate around the nares, and significantly decreased absolute kidney weights in females. In addition, a significant decrease in platelets (males/females), absolute/relative liver weights (males), and trachea/lung weights (females) was noted

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A sub-acute inhalation study with benzoic acid was evaluated by the WHO. In this study, 10 rats/sex/dose were exposed to 0, 25, 250, or 1200 mg benzoic acid dust aerosol/m3 for 6 h per day and 5 days per week over 4 weeks. As only one male and one female died in the highest dose group, it is concluded that the acute LC50 of benzoic acid exceeds 1200 mg/m3.