Reaction mass of 2-methylbutyl acetate and pentyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The acute toxicity was examined following oral administration of various amounts of primary amyl acetate to male and female rats. Rats were observed for up to 14 days post-dosing. A gross pathological examination was performed on each rat.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-methylbutyl acetate and pentyl acetate

EC Number:

908-918-1

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 2-methylbutyl acetate and pentyl acetate

Details on test material:

Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)
Clear, non-viscous liquid. No additional information available.

Test animals

Species:

rat

Strain:

other: Hilltop-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals are maintained on appropriate commercial diet and municipal water. Both are available ad libitum except during periods of fasting (rat peroral test), manipulation or restraint.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Hilltop-Wistar albino rats, weighing between 200 and 300 g, receive the test material by stomach intubation with a ball-end stainless steel needle. The
sample is injected through the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution. The rats are fasted overnight before dosing. Five males and 5 females are included on each level.

Doses:

4.0, 8.0 and 16.0 ml/kg for males and 4.0, 8.0, 11.3 and 16.0 ml/kg for females (corresponding to 3502.4, 7004.8 and 14009.6 mg/kg for males and 3502.4, 7004.8, 9894.3 and 14009.6 mg/kg for females, calculated assuming a test substance density of 0.8756 g/ml)

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not specified

Details on study design:

Groups of 5 male or female rats were weighed and dosed with undiluted primary amyl acetate. Survivors were weighed 7 and 14 days post-dosing. Animals were observed for 14 days post-dosing. Animals that died or survived were subjected to a gross necropsy examination.

Statistics:

LD50's are calculated by the moving average method (Thompson, 1947) and are based on a 14-day observation period.

Reference
Thompson, W.R. (1947). Use of moving averages and interpolation to estimate median-effective dose. Bact. Reviews 11:115.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 7 004.8 - < 14 009.6 mg/kg bw

Based on:

test mat.

Remarks on result:

other: calculated from 8 and 16 ml/kg

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

12 258.4 mg/kg bw

Based on:

test mat.

95% CL:

10 594.8 - 14 272.3

Remarks on result:

other: calculated from 14 ml/kg (12.1 - 16.3 ml/kg)

Mortality:

Male rats
2/5 died one day after dosing with 16.0 ml/kg
0/5 died following dosing with 4.0 or 8.0 ml/kg

Female rats
4/5 died one day after dosing with 16.0 ml/kg
0/5 died after dosing with 4.0, 8.0 or 11.3 ml/kg

Clinical signs:

other: Male rats dosed with 16.0 ml/kg: Sluggishness, unsteady gait at 45 min; lacrimation, slow respiration prostration at 4 hr. Survivors recovered at 2 days. No clinical signs noted in male rats dosed with 4.0 or 8.0 ml/kg. Female rats dosed with 16.0 ml/kg

Gross pathology:

Male rats
16.0 ml/kg: In victims, 1 with liver blanched, intestines green; 1 with hydronephrosis. In survivors, nothing remarkable.
8.0 ml/kg: Nothing remarkable.
4.0 ml/kg: Nothing remarkable.

Female rats
16.0 ml/kg: In victims, livers blanched red discoloration on peri-nasal fur of 1. In survivor nothing remarkable.
11.3 ml/kg: Lungs mottled dark red and red.
8.0 ml/kg: Nothing remarkable.
4.0 ml/kg: Nothing remarkable.

Other findings:

No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for male and female rats is >16.0 and 14.0 ml/kg, respectively.

Executive summary:

The acute oral toxicity of primary amyl acetate was examined in rats. The oral LD50 for male and female rats is >16.0 and 14.0 ml/kg, respectively.