Registration Dossier
Registration Dossier
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EC number: 239-827-9 | CAS number: 15733-89-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-dihydro-2-oxoquinoline-4-carboxylic acid
- EC Number:
- 239-827-9
- EC Name:
- 1,2-dihydro-2-oxoquinoline-4-carboxylic acid
- Cas Number:
- 15733-89-8
- Molecular formula:
- C10H7NO3
- IUPAC Name:
- 1,2-dihydro-2-oxoquinoline-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 6 animals, 3 animals/group
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single oral gavage administration was followed by a 14-day observation period.
- Doses:
- 2000 mg/kg bw was selected to be the starting dose
- No. of animals per sex per dose:
- 6 animals, 3 animals/group
- Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- ACIDE HYDROXY did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- All animals were symptom-free during the observation period at a dose level of 2000 mg/kg bw.
- Body weight:
- There were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age.
- Gross pathology:
- There was no evidence of the macroscopic changes at a dose level of 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item ACIDE HYDROXY was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
According the GHS criteria, classification of ACIDE HYDROXY can be ranked as "Category 5 or Unclassified" for acute oral exposure. - Executive summary:
The single-dose oral toxicity study with ACIDE HYDROXY was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris) in Crl:WI Wistar female rats.
Two groups of three female Crl:WI rats were treated with the test itemat a dose level of 2000 mg/kg body weight (bw) (Group 1 and Group 2).
ACIDE HYDROXY did not cause mortality at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute oral LD50 value of the test item ACIDE HYDROXY was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
According the GHS criteria, classification of ACIDE HYDROXY can be ranked as "Category 5 or Unclassified" for acute oral exposure.
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