N-[3-(trimethoxysilyl)propyl]butylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(only limited information on test procedure and test material identity are given, and no test material purity is stated in the study report)

Principles of method if other than guideline:

Only limited information on procedure and results is given in the study report. The test material was administered by stomach intubation to Wistar-derived male rats.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(trimethoxysilyl)propyl]butylamine

EC Number:

250-437-8

EC Name:

N-[3-(trimethoxysilyl)propyl]butylamine

Cas Number:

31024-56-3

Molecular formula:

C10H25NO3Si

IUPAC Name:

butyl[3-(trimethoxysilyl)propyl]amine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: none
- Diet: appropriate diet ad libitum (not further specified)
- Water: ad libitum (not further specified)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg

Doses:

0.5, 1, 2, 4, 8, and 16 mL/kg bw, equivalent to 475, 950, 1900, 3800, 7600, and 15200 mg/kg bw (calculated based on a density of 0.95 g/cm³)

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 along with the 95% confidence limits was calculated by the moving average method based on a 14 day observation period.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

12 825 mg/kg bw

Based on:

test mat.

95% CL:

>= 551 - <= 3 192

Remarks on result:

other: (equivalent to 13.5 mL/kg bw (95% CL 5.38 - 33.6 mL/kg bw); calculated based on a density of 0.95 g/cm³)

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

475 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (equivalent to 0.5 mL/kg bw; calculated based on a density of 0.95 g/cm³)

Mortality:

- 16 mL/kg bw: 3/5 (all animals died 30-35 min after dosing)
- 8 mLl/kg bw: 1/5 (animal died on day 7 post-dosing)
- 4 mL/kg bw: 2/5 (animals died 20 min after dosing and on day 1); repeated for confirmatory purpose: deaths 2/5 on days 0 and 1
- 2 mL/kg bw: 2/5 (deaths occured 15 and 20 min after dosing)
- 1 ml/kg bw: 1/5 (animal died 30 min after dosing)
- 0.5 mL/kg bw: 0/5

Clinical signs:

other: - 16 mL/kg bw: Sluggish (survivers) at 35 min; salivation - 8 mL/kg bw: Diarrhoea at day 1 - 4 mL/kg bw: Salivation; repeated for confirmatory purpose: Unsteady gait; salivation 5 min after dosing; survivors recovered after 1 day. - 2 mL/kg bw: Unsteady g

Gross pathology:

In victims, the stomach was gas-filled, the glandular portions were injected, and the intestines were injected or contained blood.
In survivors, nothing remarkable was observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

The test item was tested for acute oral toxicity according to a test protocol that is comparable to the appropriate OECD test guideline, but without GLP compliance. The test material was administered by stomach intubation to 5 male rats each dose group. The LD50 was determined to be 12825 mg/kg bw. The predominant clinical signs detected were salivation, unsteady gait, sluggishness, and diarrhoea. No deaths and no clinical signs throughout the study period were observed at 425 mg/kg bw. Based on this data, classification for acute oral toxicity according to EC/1272/2008 is not warranted.