1,1,3-trimethylindan-4-amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Jul - 21 Aug 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

GLP compliance unknown, minor deviations from guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted 17 Dec 2001

Deviations:

yes

Remarks:

- Animals should be 8-12 weeks old, but were 7 weeks old - No information on sighting study

GLP compliance:

not specified

Remarks:

in-house safety study

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine

EC Number:

838-724-1

Cas Number:

94568-76-0

Molecular formula:

C12H17N

IUPAC Name:

1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan Inc.
- Age at study initiation: 7 weeks
- Weight at study initiation: 161 - 190 g
- Fasting period before study: Animals were fasted 20 h prior to administration and 4 h after.
- Housing: 2 - 3 animals per cage in aluminium cages
- Diet: solid mouse and rat chow (CRF-1, Oriental Yeast Co., Ltd.); ad libitum (besides fasting period)
- Water: filter-treated Osaka municipal tap water automatic water drinking device; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 40 - 70
- Air changes (per hr): ≥ 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Remarks:

undiluted solution was administered

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.11 mL/Kg (2000 mg/kg bw)

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 10 and 30 minutes and 1, 2 and 4 hours after administration and once daily thereafter, for 14 days. Individual body weights were determined immediately before administration, 7 and 14 days after administration, and in the event of being discovered dead.
- Necropsy: Performed at the end of the observation period and in the event of being discovered dead.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg bw: 1/5 females died 2 days after administration;
2000 mg/kg bw: 2 animals and 1 animal were found dead 2 days and 3 days after administration, respectively (cumulative mortality 3/5 females)

Clinical signs:

other: - 300 mg/kg bw: Excess salivation in 1 animal (10 and 30 min after administration); irregular respiration in 1 animal (from 10 min to 1 h, and 4 h after administration); ataxic gait in 1 animal (from 30 min to 1 h after administration); staining around th

Gross pathology:

300 mg/kg bw:
- animals found dead: Scattered reddened foci in the mucosa of the glandular stomach were noted.
- animals sacrificed at termination: Necropsy and histopathological examination revealed no substance-related findings.
2000 mg/kg bw:
- animals found dead: Retention of gas in the stomach was seen in 1 of the dead animals, and scattered reddened foci in the mucosa of the glandular stomach were noted in all 3 dead animals.
- animals sacrificed at termination: A small thymus was noted in 1 animal, while the other showed no effect attributable to administration of the test substance.

Applicant's summary and conclusion

Interpretation of results:

other: Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 value of 300 - 2000 mg/kg bw was determined.