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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
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:
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: Sluggishness, unsteady gait at 45 min; lacrimation, prostration, slow respiration at 4 hr. Survivor recovered at 1 day.
Female rats dosed with 11.3 ml/kg: Sluggishness at 2 hr. Recovery at 1 day.
No clinical signs noted in female rats dosed with 4.0 or 8.0 ml/kg.
Body weight:
Male rats
16.0 ml/kg: survivors gained on average 107 g during 14 day observation period.
8.0 ml/kg: rats gained on average 122 g during 14 day observation period.
4.0 ml/kg: rats gained on average 127 g during 14 day observation period.

Female rats
16.0 ml/kg: survivor gained 51 g during 14 day observation period.
11.3 ml/kg: survivors gained on average 54 g during 14 day observation period.
8.0 ml/kg: survivors gained on average 59 g during 14 day observation period.
4.0 ml/kg: survivors gained on average 59 g during 14 day observation period.
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.