2H-Indol-2-one, 7-fluoro-1,3-dihydro-

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 EU/OECD-guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

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

Test material information

Constituent 1

Reference substance name:

7-fluoro-2,3-dihydro-1H-indol-2-one

EC Number:

676-237-4

Cas Number:

71294-03-6

Molecular formula:

C8H6FNO

IUPAC Name:

7-fluoro-2,3-dihydro-1H-indol-2-one

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Doses:

50, 300, 2000 mg/kg bw

No. of animals per sex per dose:

15 animals, 3 animals/group

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One of six females dosed at 50 mg/kg bw were found dead on Day 2.
No mortality was observed in six females dosed at 300 mg/kg bw.
Two of three females dosed at 2000 mg/kg bw were found dead on Day 0 or Day 1.

Clinical signs:

other: 50 mg/kg body weight (six animals): Treatment with test item at the dose level of 50 mg/kg bw caused decreased activity (2/6), hunched back (6/6), piloerection (1/6), incoordination (1/6) and dyspnoea (1/6). Surviving animals were symptom-free from Day 2.

Gross pathology:

Found dead
Three females were found dead on Day 0, 1 or 2.
Yellow liquid material found in the digestive contents of the stomach and/or
duodenum and jejunum in 2 females dosed at 2000 mg/kg bw was considered to be
test item-related.
In the female dosed at 50 mg/kg bw, dilated thoracic esophagus with creamy brown
material mixed with diet was observed and considered as regurgitated test item due to
possible gastro-oesophageal reflux.
In addition, dark/red discoloration of the non-collapsed lungs or red dry material at the
perioral/perinasal fur, were regarded as agonal or post mortem.

Other findings:

TERMINAL (DAY 14)
There was no evidence of the macroscopic observations in animals dosed at 300 mg/kg bw and terminated on Day 14.
No test item-related changes were seen in surviving animals dosed at 50 or 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item was found to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats.