4-tert-butylbenzaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10/08/1990 to 10/09/1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline compliant proprietary study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

A non-standard strain was used in the studybut this is not considered to have affected the validity of the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butylbenzaldehyde

IUPAC Name:

tert-butylbenzaldehyde

Test material form:

other: liquid

Details on test material:

The test material was tert-butylbenzaldehyde, obtained from Givaudan Ltd., with batch number 179024. The test material was a liquid, with a purity of 96.8%.

Test animals

Species:

rat

Strain:

other: Fü-albino SPF outbred stock

Sex:

female

Details on test animals or test system and environmental conditions:

The animals were female, outbred stock, IBM: RORO, Fü-albino SPF rats. They were aged approximately 6 weeks at administration, and weighed 98.4-113.5 g. The rats were randomly selected at delivery, and acclimatised to the laboratory conditions for 7 days. They were housed individually in labelled cages, with ad libitum access to food (maintenance diet GLP 343 for rats) and tap water. The animal room was air conditioned, maintained at a temperature of 20-24°C and relative humidity of 45-65% with a 12 h light/dark cycle. The rats were fasted overnight (approximately 18 hours) prior to dosing, feed was returned to the cages approximately 3 hours after dosing.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: rapeseed oil

Details on oral exposure:

The test material was suspended in rapeseed oil (Rüböl, DAB 6) using a magnetic stirrer. Homogeneity of the dosing suspension was maintained during treatment using the magnetic stirrer. The preparation was made prior to dosing. The dose volume was 10 ml/kg bw.

Doses:

200, 500 and 800 mg/kg bw.

No. of animals per sex per dose:

5 females per dose level

Control animals:

no

Details on study design:

A preliminary study was conducted with 4 male and 4 female rats, to determine the most sensitive sex. The rats were given a single oral dose of 500 mg/kg bw. Two females died, therefore female rats were selected for the main study as females appeared to be the most sensitive sex.
Observations for mortality were made following dosing for 14 days. Clinical signs of toxicity were recorded daily (except on weekends). Body weights were recorded immediately prior to treatment (Day 0), then on Days 3, 7, 10 and 14. All surviving rats were sacrificed and subject to gross examination.

Statistics:

Not required.

Results and discussion

Preliminary study:

Two female rats in the preliminary study died (dose = 500 mg/kg bw) therefore female rats were selected for the main study to represent the most sensitive species.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1/5 rats administered 800 mg/kg bw/d died

Mortality:

One rat administered 800 mg/kg bw died about 7 hours after treatment. There were no other deaths.

Clinical signs:

The 800 mg/kg bw rat that died showed weak condition, abnormal posture and reduced body temperature prior to death. Clinical signs observed in other animals included diarrhoea, soiled urogenital region and piloerection. Diarrhoea and soiled urogenital region disappeared within 3 days following dosing.

Body weight:

Body weight gain was reduced in surviving animals administered 800 mg/kg bw.

Gross pathology:

No abnormalities were detected.

Other findings:

No other findings were reported.

Any other information on results incl. tables

Clinical signs observed in female rats administered tert-butylbenzaldehye

Clinical sign	Incidence of findings
	200 mg/kg bw	500 mg/kg bw	800 mg/kg bw
Diarrhoea	2/5	3/5	1/5
Soiled urogenital region	0/5	3/5	1/5
Piloerection	0/5	0/5	1/5
Death	0/5	0/5	1/5

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 in female rats is considered to be greater than 800 mg/kg bw/d.

Executive summary:

The acute oral toxicity of tert-butyl benzaldehyde was investigated in fifteen female Fü-albino SPF rats. A preliminary study was conducted which determined that females were the most sensitive sex due to two deaths observed at 500 mg/kg bw. In the main study, the test material was administered in rapeseed oil to fasted rats by gavage at doses of 200, 500 or 800 mg/kg bw. The rats were observed for signs of toxicity and mortality for 14 days. Body weights changes were recorded, and surviving rats were sacrificed at the end of the observation for gross necropsy. One female rat administered 800 mg/kg bw died approximately 7 days after dosing. There were no other mortalities. Reduced body weight gain was observed in rats given 800 mg/kg bw. Clinical signs of toxicity included diarrhoea, soiled urogenital region and piloerection, seen mainly during the first 3 days. No abnormalities were detected at necropsy. It is concluded that the acute oral LD₅₀ in female rats is greater than 800 mg/kg bw.