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EC number: 275-156-8 | CAS number: 71048-82-3
Toxicological information
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: Non-GLP, non-guideline, animal experimental study, limitations in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report Date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Equivalent or similar to OECD Guideline 401 (Acute Oral Toxicity).
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- colorless liquid
Code No. SG 082367 (17151)
FDRL Identification No. 78-0554
Test animals
- Species:
- mouse
- Strain:
- other: BLU: Ha (ICR)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, NY
- Weight at study initiation: between 15 - 36 grams
- Fasting period before study: The animals were fasted overnight (approximately 18 hours) prior to dosing
- Housing: plastic cages with wood shavings as bedding, in groups of five
- Diet (e.g. ad libitum): Charles River pelleted RMH 3000 supplied ad libitum after dosing
- Water (e.g. ad libitum): supplied ad libitum after dosing
- Acclimation period: at least three days prior to test initiation
ENVIRONMENTAL CONDITIONS
- Temperature: 70 ± 3°F
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test material was administered as a corn oil solution at varying concentrations, at a constant volume of 20 ml/kg.
- Doses:
- Three preliminary searches were performed before the actual LD50 was set up. The design represented in the table of log dose schedule, as supplied by the client, was used as a tool for dosage selection.
Dose levels: 940, 1346, 1475, 1600, 1902, 2025, 2150, 2225, 2350, 2692 mg/kg - No. of animals per sex per dose:
- 5 male and 5 females
- Control animals:
- no
- Details on study design:
- Animals were observed for 14 days following administration of the test material. Toxic effects and mortality were recorded throughout the duration of the test period.
- Statistics:
- First the LD50 was calculated by the methos of Knudsen and Curtis; only three to four dose levels were used and the resulting 95% confidence intervals appeared to be smaller than felt the data warranted. Recalculation was done by Finney Probit analysis (December 7, 1979)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 400 mg/kg bw
- 95% CL:
- >= 1 085 - <= 1 806
- Remarks on result:
- other: based on the recalculation by Finney Probit analysis (December 7, 1979)
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 850 mg/kg bw
- Remarks on result:
- other: 95% CL cannot be calculate from this data; based on the recalculation by Finney Probit analysis (December 7, 1979)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 625 mg/kg bw
- 95% CL:
- >= 1 332 - <= 1 990
- Remarks on result:
- other: based on the recalculation by Finney Probit analysis (December 7, 1979)
- Mortality:
- Male;
940 mg/kg bw: 2/5 animals
1346 mg/kg bw: 0/5 animals
1475 mg/kg bw: 2/5 animals
1600 mg/kg bw: 4/5 animals
1902 mg/kg bw: 4/5 animals
2025 mg/kg bw: 4/5 animals
2150 mg/kg bw: 4/5 animals
2225 mg/kg bw: 3/5 animals
2350 mg/kg bw: 4/5 animals
2692 mg/kg bw: 4/5 animals
Female;
940 mg/kg bw: 0/5 animals
1346 mg/kg bw: 0/5 animals
1475 mg/kg bw: 1/5 animals
1600 mg/kg bw :4/5 animals
1902 mg/kg bw: 5/5 animals
2025 mg/kg bw: 5/5 animals
2150 mg/kg bw: 4/5 animals
2225 mg/kg bw: 3/5 animals
2350 mg/kg bw: 5/5 animals
2692 mg/kg bw: 5/5 animals - Clinical signs:
- Males;
All animals at all doses showed decrease of activity.
Ataxia at all dose levels, not with all animals. Salivation at dose 1600 with 3 animals. Urinary incontinence at all doses (except 1475 and 2692), not all animals. Tremors at all doses >1600 (except 2692), not all animals. Death at all doses >1346 (except 2692), not all animals.
Females;
All animals at all doses showed decrease of activity.
Ataxia at all dose levels, not with all animals. Salivation at dose 1600 with 3 animals. Urinary incontinence at all doses (except 2692), not all animals. Tremors at all doses >1475 (except 2692), not all animals. Death at all doses >1475 (except 2692), not all animals. - Body weight:
- Male;
Dose: 940 mg/kg bw; initial 23.20 ± 1.66, 14 days 31.00 ± 2.00
Dose: 1475 mg/kg bw; initial 22.40 ± 1.69, 14 days 27.67 ± 1.45
Dose: 1600 mg/kg bw; initial 27.20 ± .97, 14 days 37.00
Dose: 1902 mg/kg bw; initial 27.00 ± 1.30, 14 days 35.00
Dose: 2025 mg/kg bw; initial 25.00 ± 1.45, 14 days 35.00
Dose: 2150 mg/kg bw; initial 25.80 ± .97, 14 days 28.00
Dose: 2225 mg/kg bw; initial 28.00 ± 1.95, 14 days 35.00
Dose: 2350 mg/kg bw; initial 25.40 ± .81, 14 days 30.00
Dose: 2692 mg/kg bw; initial 25.60 ± 1.63, 14 days 31.00
Female;
Dose: 940 mg/kg bw; initial 23.00 ± 1.14, 14 days 34.80 ± 1,53
Dose: 1475 mg/kg bw; initial 21.20 ± 0.58, 14 days 23.00 ± 1.22
Dose: 1600 mg/kg bw; initial 27.40 ± 1.03, 14 days 30.00
Dose: 1902 mg/kg bw; initial 25.20 ± .37
Dose: 2025 mg/kg bw; initial 25.40 ± .68
Dose: 2150 mg/kg bw; initial 23.60 ± .68, 14 days 30.00
Dose: 2225 mg/kg bw; initial 24.80 ± .92, 14 days 32.00 ± 2.00
Dose: 2350 mg/kg bw; initial 23.40 ± 1.36
Dose: 2692 mg/kg bw; initial 25.40 ± 1.50 - Gross pathology:
- Summary of Necropsy Findings (Combined Data Males and Females):
Dose 940 mg/kg: Intestines: vascularized.
Dose 1346 mg/kg: No deaths.
Dose 1475 mg/kg: Lungs: dark. Liver: pale. Spleen: pale, pale and granular; appears large. Kidneys: pale. G.I. Tract: filled with brown fluid. Intestines: white. Stomach: fluid filled.
Dose 1600 mg/kg : Lungs: pale. Liver: pale. Kidneys: pale. Spleen: dark. G.I. Tract: containing yellow like substance. Stomach: full.
Dose 1902 mg/kg: Lungs: dark. Liver: pale. Kidneys: pale and mottled. Spleen: dark.
Dose 2025 mg/kg: Lungs: dark. Liver: pale. Kidneys: pale and mottled. Spleen: pale.
Doses 2150 mg/kg: Lungs: pinkish gray. Liver: pale. Kidney: pale and mottled. Spleen: dark. - Other findings:
- no data
Applicant's summary and conclusion
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