Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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: Study meets generally accepted scientific principles (restriction: purity unknown)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA, Nycum JS
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 30: 470-476
Reference Type:
study report
Title:
Unnamed
Year:
1961

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Standardized test protocol using 5 male rats per treatment (dose) with 14 days observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Propyl acetate, purity unknown

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breeding
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: no
- Diet (e.g. ad libitum): Rockland rat diet


ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
4.0, 8.0, or 16 mL/kg bw, equivalent to 3.55, 7.10, or 14.21 g/kg bw
No. of animals per sex per dose:
5 males
Control animals:
not specified
Details on study design:
Animals were observed for signs of toxicity after dosing, and throughout the 14-day observation interval. Animals were weighed prior to dosing and at the end of the observation interval. Animals that died on study were subjected to necropsy; surviving animals were sacrificed at the end of the observation interval and necropsied.
Statistics:
Thompson's method of calculating the LD50 was applied to the 14-day mortality data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 8 700 mg/kg bw
95% CL:
6 600 - 11 450
Remarks on result:
other: corresponding to a LD50 of 9.8 mL (7.5 - 12.9 mL), calculated with a density of 0.888 g/mL as prefered result of the OECD SIDS
Mortality:
Not reported in the publication.
Clinical signs:
Not reported in the publication.
Body weight:
Not reported in the publication.
Gross pathology:
Not reported in the publication.

Applicant's summary and conclusion