Aspartic acid, N-[3-(trimethoxysilyl)propyl]-, 1,4-diethyl ester

Endpoint summary

Description of key information

LD50 oral (rat): ≥ 5000 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Harlan-Winkelmann GmbH (Borchen, Germany)
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 162 -185 g
- Fasting period before study: 16-24 hours
- Housing: in groups
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

- Application volume: 5 ml/kg bw

- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes

Statistics:

none (limit test)

Sex:

female

Dose descriptor:

other: LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Mortality:

All 6 animals survived the treatment.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross pathological findings were observed.

Other findings:

none

NOEL: 2000 mg/kg bw

Executive summary:

A single oral dose of 2000 mg/kg body weight was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD guideline 423 the oral LD50 cut-off of KURG 101 is >= 5000 mg/kg bw for rats (GHS Category 5 / unclassified).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The study is GLP compliant and is of high quality (Klimisch score=1)

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

The acute oral toxicity of KURG 101 was low with an LD50 value exceeding 5000 mg/kg bw in rats according to OECD TG 423. At a test dose of 2000 mg/kg bw no animal died and no clinical signs were observed during the 14-day post observation period (Schuengel, 2003).

Justification for selection of acute toxicity – oral endpoint

Only one study available

Justification for classification or non-classification

Based on the test results (LD50 oral ≥ 5000 mg/kg bw) a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.