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EC number: 207-837-2 | CAS number: 497-18-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Initiation date:October 14, 1980; Termination date: Octerber 27 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Carbohydrazide
- IUPAC Name:
- Carbohydrazide
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): EHS-152
- Physical state: Clear, colourless liquid:
- Lot/batch No.: B-0228 (8-18-80)
- Storage condition of test material: Room temperature in a locked test compound cabinet
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries, Inc., Indianapolis, Indiana
- Age at study initiation: Young adult
- Weight at study initiation: 213 to 287 grams
- Fasting period before study: Yes
- Housing: The animals individually housed in wire-bottomed cages.
- Acclimation period: The rats were quarantined and acclimated to laboratory conditions for 21 days prior to initiation of the study. Animals were examined twice during the quarantine period.
ENVIRONMENTAL CONDITIONS
Room conditionsm as well as availability of adequate food and water were checked and any noteworthy conditions recorded.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
No vehicle used.
MAXIMUM DOSE VOLUME APPLIED: 4.9 ml/kg
DOSAGE PREPARATION (if unusual): Individual dose amounts were calculated using fasted bodyweights (day 0, mean: males 261 g, females 210 g) taken prior to dosing. The test material was measured in a plastic disposable syringe and administered directly into the rats stomach as a single dose using a rubber catheter and tubing adapter. - Doses:
- One dose leve of 5 g/kg (5000 mg/kg)
- No. of animals per sex per dose:
- 5 males and 5 females at 5000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosing and at least twice daily thereafter for a total of 14 days. All animals were weighed on days -1, 0, 6 and 13.
- Necropsy of survivors performed: yes, all surviving animals were sacrificed by carbon dioxide asphyxiation and a gross necropsy performed on the visceral and thoracic cavities.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred among the test animals.
- Clinical signs:
- other: Findings recorded during the 14 day observation period were: Three to Four and One-Half Hours after Dosing: Slightly lethargic and ataxic (one male and one female at 4.5 hours) Slightly loose feaces (one female) Days 1 through 13: Slightly ataxic (1 mal
- Gross pathology:
- Examination of the thoracic and visceral cavities of animals at necropsy revealed no significant findings.
Any other information on results incl. tables
As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.
- Executive summary:
When the test substance was administered orally at one dose level (5000 mg/kg) to one group containing ten rats (5 males and 5 females), no deaths occurred and systemic signs noted were slight ataxia and lethargy (days 0, 3 and 4) in 3 animals and slightly loose faeces (day 0) in one animal.
As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.
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