N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine

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

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

(no constant volume was applied)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Short-Term and Long-Term Toxicology Groups Final Report (December 1979)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine

EC Number:

245-642-4

EC Name:

N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine

Cas Number:

23410-40-4

Molecular formula:

C9H24N2O2Si

IUPAC Name:

N-{3-[dimethoxy(methyl)silyl]-2-methylpropyl}ethane-1,2-diamine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Industries
- Weight at study initiation: 250±40 g
- Fasting period before study: 16 h
- Housing: individually in conventional design stainless steel, wire mesh bottom cages
- Diet: Purina Rodent Chow, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
not specified (under controlled laboratory conditions)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

250, 500, 1000, and 1600 mg/kg bw (based on the results of a screening test)

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: frequently on the first day of dosing and twice a day thereafter (at least 4 h apart)
- Frequency of weighing: 24 h, 7 and 14 days after dosing
- Necropsy of survivors performed: yes

Statistics:

The oral median lethal dose, 95% confidence interval, and approximate slope of the dose response curve were calculated by a computerised version of Finney's (1972) Probit Method.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

436 mg/kg bw

Based on:

test mat.

95% CL:

210 - 730

Remarks on result:

other: Deaths occurred in all dose groups in 1/5 females at 250 mg/kg bw, 3/5 females at 500 mg/kg bw, 5/5 females at 1000 mg/kg bw, and 5/5 females at 1600 mg/kg bw.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

866 mg/kg bw

Based on:

test mat.

95% CL:

567 - 1 368

Remarks on result:

other: Deaths occurred in 1/5 males at 500 mg/kg bw, 3/5 males at 1000 mg/kg bw, and 5/5 males at 1600 mg/kg bw.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

653 mg/kg bw

Based on:

test mat.

95% CL:

447 - 892

Mortality:

Deaths occurred in all dose groups with 1/5 females at 250 mg/kg bw, 3/5 females and 1/5 males at 500 mg/kg bw, 5/5 females and 3/5 males at 1000 mg/kg bw and 5/5 males and females each at 1600 mg/kg bw. The females exhibited to be the more sensitive species. The deaths occurred within one and a half hours following dosage in all cases except three animals, which died several hours later.

Clinical signs:

other: Surviving animals appeared normal within 48 h. Generally, signs of toxicity exhibited by rats included extreme lethargy, ataxia, convulsions and coma.

Gross pathology:

Necropsy of animals that died during the study showed haemorrhagic condition of the gastrointestinal tract. However, terminal sacrifice of surviving animals did not reveal any compound related gross pathological alterations in the tissues and organs examined.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are met, Category 4 classification required according to Regulations (EC) No 1272/2008

Conclusions:

The test item was investigated for acute oral toxicity in a study conducted similar to OECD 401, and in compliance with GLP. 5 Sprague Dawly rats per sex received single doses of of 250, 500, 1000, and 1600 mg/kg bw of the test material via gastrointestinal intubation. Deaths occurred in all dose groups with 1/5 females at 250 mg/kg bw, 3/5 females and 1/5 males at 500 mg/kg bw, 5/5 females and 3/5 males at 1000 mg/kg bw and 5/5 males and females each at 1600 mg/kg bw. Signs of toxicity exhibited by surviving rats included extreme lethargy, ataxia, convulsions and coma, but were resolved within 48 h. Food consumption and body weight gains were slightly depressed during the first 24 h following treatment, but appeared normal during the remaining part of the study period. Necropsy of animals that died during the study showed haemorrhagic condition of the gastrointestinal tract. However, terminal sacrifice of surviving animals did not reveal any compound related gross pathological alterations in the tissues and organs examined. Based on the outcome of the study, the LD50 value for males was calculated to be 866 mg/kg bw, whereas the LD50 value for females was determined to be 436 mg(kg bw. The combined LD50 value (male/female) was calculated to be 653 mg/kg bw.