Registration Dossier
Registration Dossier
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EC number: 683-287-0 | CAS number: 877670-90-1
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:
- other: GLP study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid
- EC Number:
- 683-287-0
- Cas Number:
- 877670-90-1
- Molecular formula:
- C18H17N3O5
- IUPAC Name:
- 2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid
- Details on test material:
- Batch 939-76
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Anthranilic Acid-AAOA did not cause mortality at 2000 mglkg bw
- Clinical signs:
- other: Treatment with Anthranilic Acid-AAOA with 2000 mgkg bw caused decreased activity and hunched back position. Yellow faeces and discolouration of the urine (deeper yellow compared to the normal) was observed. The first signs appeared at 1 hour after the tre
- Gross pathology:
- There was no evidence of Anthranilic Acid-AAOA -related findings at necropsy. Red
mottling of the lungs in 3 rats (872, 873 and 874) and enlarged right kidney (869) were
considered as agonal and incidental changes, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LDS0 value of the test item
Anthranilic Acid-AAOA was above 2000 mglkg bw in female CRL:(WI) BR rats.
Anthranilic Acid-AAOA was ranked into Category 5 of Globally Harmonized
Classification System.
According to the EU labelling regulations Commission Directive 2001159/EC.,
Anthranilic Acid-AAOA does not need to be classified.
According to the guidance provided by the U.S. EPA, Anthranilic Acid - AAOA
was ranked into Toxicity Category III "Caution". - Executive summary:
The single-dose oral toxicity of Anthranilic Acid - AAOA was assessed according to the
acute toxic class method (OECD 423, Directive 2004173lEC B.l.tris and OPPTS
870.1 100) in CRL: (WI) BR rats.
The study was performed at a dose level of 2000 mglkg bw. Two groups of three
female CRL:(WI) BR Wistar rats were treated with Anthranilic Acid-AAOA at a dose
level of 2000 mgfkg bw (Group 1 and Group 2). No mortality occurred after dosing
with 2000 mglkg bw, so no additional treatment was performed.
A single oral treatment was carried out by gavage for each animal after an overnight
food withdrawal. Anthranilic Acid-AAOA was administered at a concentration of
200 mg/rnL (Group 1 and Group 2) prepared in Distilled Water with a treatment
volume of 10 mL/kg bw.
Clinical observations were performed for all animals in Group 1 at 10 and 30 minutes
and 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. In case of
Group 2, clinical observation was performed at 30 minutes, l,2, 3,4 and 6 hours after
dosing and daily for 14 days thereafter. Food was made available again 3 hours after
the treatment. Body weight was measured weekly. Gross necropsy was performed on
all animals just after the death or at termination of examination (day 14).
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