Registration Dossier

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:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch 939-76

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:
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 treatment.
Body weight:
Treatment with Anthranilic Acid-AAOA had no impact on the body weight change of
animals during the study.
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).