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

Endpoint summary

Description of key information

The test substance is non toxic after single oral exposure (LD50, rat: > 2000 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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)

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The study is GLP compliant

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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.

Justification for selection of acute toxicity – oral endpoint
There are identical LD50 values for mouse and rat available. The rat study was selected because the preferred test species for evaluation of acute toxicity by the oral route is the rat.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.