Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The acute dermal toxicity of primary amyl acetate was examined with male and female rabbits. The test material was in contact with skin for 24 hours. The application site was examined 1 hour and 7 and 14 days after the contact period.
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:
rabbit
Strain:
New Zealand White
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 restraint.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
New Zealand White rabbits, weighing between 2.0 and 3.0 kg, are immobilized during a 24-hr contact period. The test material is retained under impervious sheeting on the clipped, intact skin of the trunk. Doses are varied by adjusting the volume or weight of the test material. After the contact period, excess fluid is removed to diminish ingestion.
Duration of exposure:
24 hours
Doses:
4.0, 8.0 and 16.0 ml/kg for males or 16.0 ml/kg for females (corresponding to 3502.4, 7004.8 and 14009.6 mg/kg for males and or 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 males or 5 females/dose
Control animals:
not specified
Details on study design:
Test material is applied to the trunk of the rabbits for 24 hours under occlusive conditions. The application site is examined 1 hour and 7 and 14 days after removal of the test material.
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:
8 326.96 mg/kg bw
Based on:
test mat.
95% CL:
5 693.22 - 14 797.64
Remarks on result:
other: calculated from 9.51 ml/kg (5.36-16.9 ml/kg)
Sex:
female
Dose descriptor:
LD50
Effect level:
> 14 009.6 mg/kg bw
Based on:
test mat.
Mortality:
Male rabbits
16.0 ml/kg: 4 of 5 died. Deaths occurred 1, 1, 2 and 5 days after dosing
8.0 ml/kg: 2 of 5 died. Deaths occurred 2 and 7 days after dosing.
4.0 ml/kg: 0 of 5 died.

Female rabbits
16.0 ml/kg: 1 of 5 died. Death occurred two days after dosing.
Clinical signs:
Male rabbits
16.0 ml/kg: Immediate signs of discomfort (intense squirming and struggling); sluggishness, unsteady gait at 1 day. Prostration before death. Survivor recovered at 5 days.
8.0 ml/kg: Sluggishness, unsteady gait at 1 day. Survivors recovered at 5 days.
4.0 ml/kg: None noted.

Female rabbits
16.0 ml/kg: Immediate signs of discomfort.
Body weight:
Male rabbits
16.0 ml/kg: Survivors gained -565 g during 14 day observation period.
8.0 ml/kg: Survivors gained on average 99 g during 14 day observation period.
4.0 ml/kg: Survivors gained on average 70 g during 14 day observation period.

Female rabbits
16.0 ml/kg: Survivors gained on average 133 g during 14 day observation period.
Gross pathology:
Male rabbits
16.0 ml/kg: In victims, liver with multiple yellow or white foci; intestines red. In survivor, liver with multiple cream-colored foci.
8.0 ml/kg: In victims, lungs of 1 mottled; liver of 1 with cream-colored foci; testes of 1 small; bladder of 1 filled with light red fluid. In survivors lungs of 1 dull dark red, with creamcolored patches, red-tan fluid in thoracic cavity.
4.0 ml/kg: Nothing remarkable

Female rabbits
16.0 ml/kg: In victim, trachea with red patches; liver with multiple white foci and dark dimpling. In survivors, nothing remarkable.
Other findings:
Clinical signs at application site
Male rabbits
16.0 ml/kg: Erythema immediately; ecchymosis at 1 day; survivor with necrosis, edema, fissuring at 14 days.
8.0 ml/kg: Erythema immediately desquamation at 7 days.
4.0 ml/kg: Erythema immediately desquamation at 7 days.

Female rabbits
16.0 ml/kg: Erythema immediately ecchymosis, desquamation, scab formation at 14 days.

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 acute dermal toxicity of primary amyl acetate in male and female rabbits was 9.51 and >16.0 ml/kg, respectively.
Executive summary:

The acute dermal LD50 of primary amyl acetate was examined. The acute dermal toxicity of primary amyl acetate in male and female rabbits was 9.51 and >16.0 ml/kg, respectively.