9H-Carbazole-9-propanoic acid, 3-amino-1,2,3,4-tetrahydro-, (3R)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(3R)-3-amino-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoic acid

EC Number:

923-144-4

Cas Number:

1182722-58-2

Molecular formula:

C15 H18 N2 O2

IUPAC Name:

3-[(3R)-3-amino-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoic acid

Test animals

Species:

rat

Strain:

other: Hsd Cpb: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: no data
- Mean weight at study initiation: 192 g - 224 g (males) or 169 g - 190 g (females)
- Housing: in groups of 5 animals
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% (v:v) aqueous tylose

Details on oral exposure:

- Application volume: 20 mL/kg bw

Doses:

2000 mg/kg

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: several times on the day odf administration and subsequently at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

none (limit test)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died after administration of 2000 mg/kg bw.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross pathological findings were observed.

Other findings:

none

Applicant's summary and conclusion

Executive summary:

In the acute toxicity study performed 1996 according to OECD TG 423 the test substance was untoxic with a LD50 value > 2000 mg/kg bw in rats. The oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain or gross pathological findings in both sexes.