3-methyl-2-butenyl acetate

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

Data source

Reference

Reference Type:

secondary source

Title:

Acute Oral LD50 in Rats with Prenyl Acetate

Author:

Rhodia Inc.

Year:

1978

Bibliographic source:

cited in TSCATS; OTS04571762

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-2-butenyl acetate

EC Number:

214-730-4

EC Name:

3-methyl-2-butenyl acetate

Cas Number:

1191-16-8

Molecular formula:

C7H12O2

IUPAC Name:

3-methylbut-2-en-1-yl acetate

Test material form:

other: liquid

Details on test material:

- Name of test substance (as cited in study report): Prenyl Acetate
- Analytical purity: 99.8%
- Physical state: liquid (clear)
- pH value: 4
- Identifying numbers: AV 307-25 (cut 25)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Flow Laboratories, Dublin, Virginia
- Weight at study initiation: 150 - 200 g
- Fasting period before study: 18 h
- Housing: 3 - 4 per sex per cage; suspended 1.3 cm wire mesh cages, 43 x 18 x 25 cm
- Diet: Wayne Lab-Blox, manufactured by A. Mills, Fort Wayne (24% crude protein, 4% crude fat, 4.5% crude fiber); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): ca. 50
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

1500, 2000, 3000, 4000 and 5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: frequently within the first 8 hours post-treatment, then twice daily for the remaining days
- Frequency of weighing: day 0, 1, 4, 7, 10, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

2 900 mg/kg bw

Based on:

test mat.

95% CL:

> 2 200 - < 3 800

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 000 mg/kg bw

Based on:

test mat.

95% CL:

> 2 500 - < 3 600

Mortality:

- 1500 mg/kg bw: 0/10 (m); 0/10 (f)
- 2000 mg/kg bw: 0/10 (m); 1/10 (f)
- 3000 mg/kg bw: 4/10 (m); 4/10 (f)
- 4000 mg/kg bw: 9/10 (m); 9/10 (f)
- 5000 mg/kg bw: 10/10 (m); 10/10 (f)

Clinical signs:

other: Clinical signs of toxicity were obseved in all dose groups. A mild depression and diarrhoea were the most common toxic signs observed in the 1500 and 2000 mg/kg bw dose groups. Few females in the 2000 mg/kg group were observed with salivation, lacrimatio

Gross pathology:

- Animals that died: heamorrhagic lungs, dark liver and sloughing / inflammatory / erosive stomach mucosa.
- Necropsied animals: no significant necropsy findings

Any other information on results incl. tables

 Table 1: Mortality

Dose Level (mg/kg bw)		Test Day				Mortality (%)
		0	1	2	3-14
1500	Male	0	0	0	0	0
	Female	0	0	0	0	0
2000	Male	0	0	0	0	0
	Female	0	1	0	0	10
3000	Male	1	3	0	0	40
	Female	0	4	0	0	40
4000	Male	4	4	1	0	90
	Female	2	5	1	1 (day 7)	90
5000	Male	4	5	1	-	100
	Female	3	7	-	-	100

 

Table 2: Mean body weights

Dose Level (mg/kg bw)		Mean body weight (g)
		day 0	day 1	day 4	day 7	day 10	day 14
1500	Male	213	232	255	274	293	315
	Female	167	183	195	202	209	217
2000	Male	211	224	244	264	285	307
	Female	166	173	183	195	204	211
3000	Male	211	210	225	246	270	292
	Female	171	175	181	190	196	202
4000	Male	213	190	213	230	259	286
	Female	169	166	129	165	165	174
5000	Male	211	222	-	-	-	-
	Female	167	151	-	-	-	-