Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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 or test system 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Route: .live2