Registration Dossier
Registration Dossier
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EC number: 421-140-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Equal number of male and female CD rats of origing Sprague-Dawley (Hsd:Sprague-Dawley(CD)) were used.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled water solution-containing 20% w/v of RSS-4 dry substance.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Preliminary sighting study: 0 (male)
Preliminary sighting study: 0 (female)
Main study: 5 (male)
Main study: 5 (female) - Control animals:
- no
- Details on study design:
- Preliminary sighting study:
No preliminary study carried out.
Results and discussion
- Preliminary study:
- 2000 mg/kg bw: Evident toxicity: N; Mortality: N
500 mg/kg bw: not administered
50 mg/kg bw: not administered
5 mg/kg bw: not administered
<5 mg/kg bw: not administered
mg/kg bw: Evident toxicity: ; Mortality:
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Dose descriptor:
- other: 2000 mg/kg bw (fixed dose initial)
- Remarks on result:
- other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 5
- Clinical signs:
- Signs of toxicity:
There were no deaths.Clinical signs of reaction to treatment
comprised of piloerection,hunched posture,waddling
gait,lethargy,respiratory disruption,partially closed
eyelids,pallor of the extremities,walking on
toes,unsteadiness,cold extremities and an ungroomed
appearance seen in all rats with faecal disturbances and
prostration notable in one or more males.
All but piloerection had resolved by Day 4 with the recovery
from the latter complete in all instances by Day 7. - Gross pathology:
- Effects on organs:
No effects - Other findings:
- All rats achieved satisfactory bodyweight gain throughout
the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
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