1H-Inden-1-amine, 2,3-dihydro-2,6-dimethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according EU/OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

equivalent or similar 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:

(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-amine

EC Number:

700-140-9

Cas Number:

752984-24-0

Molecular formula:

C11H15N

IUPAC Name:

(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

300 and 2000 mg/kg body weight (bw)

No. of animals per sex per dose:

3 female rats

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:

All animals dosed with 2000 mg/kg bw died during the observation period.

Clinical signs:

other: Clinical cramps, tremor, labored breathing, lateral position and gasping.

Gross pathology:

The necropsy did not reveal any treatment-related findings.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

Under the conditions of this study the median lethal dose of the test item after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.