4-Methyl-N-[3-(triethoxysilyl)propyl]-2-pentanimine

Endpoint summary

Description of key information

The substance was tested for acute oral toxicity according to OECD TG 423 and under GLP. Two females dosed with a single application of 2000 mg/kg bw were found dead within two hours post-treatment. No further mortality occurred during an observation period of 14 days. A dose of 300 mg/kg bw did not result in any mortalities. The LD50 cut-off (rat) was therefore determined to amount 1000 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:

27 June 2006 - 14 july 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Specific details on test material used for the study:

Batch/Lot: 630401
Purity: 92.92%

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, germany.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9-12 weeks old

- Fasting period before study: overnight
- Housing: 3 animal per cage, Macrolon cages (MIY type, height 18 cm.)
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 */- 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

300 mg/kg bw (0.323 ml/kg bw)
2000 mg/kg bw (2.15 ml/kg bw)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily observation, weighing on day 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

1 000 mg/kg bw

Mortality:

Two females dosed at 2000 mg/kg were found dead within two hours post-treatment. No further mortality occurred.

Clinical signs:

other: Dose level Clinical signs 300 mg/kg Hunched posture 2000 mg/kg hunched posture and salivation the surviving animals had recovered by day 2 (300 mg/kg) and 5 (2000 mg/kg).

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

See attached file for data tables.

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

1 000 mg/kg bw

Justification for classification or non-classification

The LD50 cut-off (rat) was determined to amount 1000 mg/kg bw in a test for acute oral toxicity according to OECD TG 423 and under GLP. According to Annex I of Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance therefore has to be classified as: harmful if swallowed (Category 4) for acute toxicity by the oral route.