2-(4-tert-butylbenzyl)propionaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (no GLP).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(no GLP)

Principles of method if other than guideline:

The study was conducted according to an internal BASF method which in principle was comparable to the OECD guideline 401. A test group consisting of 5 animals/dose was treated by single gavage with an aqueous solution of the test substance. Animals weight was taken prior to application, at regular intervals during the observation period and one day before termination. The animals were observed for mortality and for clinical signs of toxicity for a period of 14 days. Animals that died during the observations period were subjected to necropsy. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy. The LD50 value was estimated on the basis of the observed mortalities

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-tert-butylbenzyl)propionaldehyde

EC Number:

201-289-8

EC Name:

2-(4-tert-butylbenzyl)propionaldehyde

Cas Number:

80-54-6

Molecular formula:

C14H20O

IUPAC Name:

3-(4-tert-butylphenyl)-2-methylpropanal

Details on test material:

- Name as cited in document: Lilial
- Analytical purity: 99%
- Batch No.: not reported
- Physical state: liquid

Test animals

Species:

rat

Strain:

other: Sprague Dawley- Hagemann

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Age at study initiation: not reported
- Body weight at study initiation: Range (male); 210-290 g, range (female); 170 - 220 g
- Fasting period before study: 15-20 h before application
- Diet: Herian MRH- Haltung; H. Eggermann KG

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.8%; 10%; 14.7%; 21.5%; 31.6% in 0.5% CMC
- Amount of vehicle: 10 ml/kg bw
- Concentration of vehicle: 0.5 %

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

681; 1000; 1470; 2150; 3160 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to application (day 1), on day 4 or 5, day 8 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Statistics:

Test for homogeniety: chi squared test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 390 mg/kg bw

95% CL:

1 019 - 1 867

Remarks on result:

other: LD50 was determined by probit analysis (Slope factor 1.94). Finney, D. J., Probit analysis, Cambridge University Press, 3rd Edition., 1971.

Mortality:

see table 1 in " Remarks on results..."

Clinical signs:

other: see table 2 in " Remarks on results...".

Gross pathology:

No abnormality was seen in survivors at the end of the study period.
Animals found dead:
- Heart: acute dilation, acute hyperemia
- Liver: clay yellow, grey-whitish, colouring of the periphery of the lopes

Any other information on results incl. tables

Table 1: Progression of mortality within the observation period

Dose (mg/kg bw)	No. of animals	Mortality within
		1h	1 d	2 d	7 d	14 d
681	5M	0/5	0/5	0/5	1/5	1/5
	5F	0/5	0/5	0/5	0/5	0/5
1000	5M	0/5	1/5	1/5	1/5	1/5
	5F	0/5	4/5	4/5	4/5	4/5
1470	5M	0/5	2/5	2/5	2/5	2/5
	5F	0/5	2/5	2/5	2/5	2/5
2150	5M	0/5	2/5	2/5	2/5	3/5
	5F	0/5	2/5	3/5	3/5	3/5
3160	5M	0/5	1/5	3/5	5/5	5/5
	5F	0/5	2/5	3/5	5/5	5/5

Table 2: Summary of the clinical signs that were recorded

	681 mg/kg	1000 mg/kg	1470 mg/kg	2150 mg/kg	3160 mg/kg
Dyspnea	xxx	xxx	xxx	xxx	xxx
Apathy	xxx	xxx	xxx	xxx	xxx
Abnormal position	xxx	xxx	xxx	xxx	xxx
Drunken gait	xxx	xxx	xxx	xxx	xxx
Atony		xxx		xxx	xxx
Loss of pain reflex				xxx
Loss of corneal reflex				xxx
Narcosis resembling state				xxx
Tremor					xxx
Spastic gait	xxx	xxx	xxx	xxx	xxx
Biting fit		xxx
Rough fur coat	xxx	xxx	xxx	xxx	xxx
Diarrhea	xxx
Skin erythema	xxx	xxx	xxx
Dehydration	xxx			xxx	xxx
Salivation		xxx
Poor general condition	xxx	xxx	xxx	xxx	xxx

^xxx symptoms observed

Table 3: Mean body weights after 14 days

	Male	Female
Dose (mg/kg bw/d)	Mean body weight after 13 days	Mean body weight after 13 days
681	270 (n=4)	241(n=5)
1000	278 (n=4)	232 (n=1)
1470	268 (n=3)	194 (n=3)
2150	260 (n=2)	203 (n=2)
3160	-	-