N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine

EC Number:

221-336-6

EC Name:

N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine

Cas Number:

3069-29-2

Molecular formula:

C8H22N2O2Si

IUPAC Name:

N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data.

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No data.

Duration of exposure:

24 hours

Doses:

1, 2, 4, 8, 16 ml/kg (males), 16 ml/kg females.

No. of animals per sex per dose:

4

Control animals:

other: solvent control, methanol

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Equivalent to 15520 mg/kg (calculated with specific gravity of 0.97 g/m3)

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Equivalent to >15520 mg/kg (calculated with specific gravity of 0.97 g/m3)

Mortality:

At 16 ml/kg 2/4 males died within 3.3 days. At 8 ml/kg 1/4 males died on day 3. At all other doses, in all other animals, there were no deaths.

Clinical signs:

other: Clinical signs in males were swollen testes at day 1; convulsions in 1 at day 1. Recovery of survivors occurred within 2 days. Erythema was present at all doses in all animals. In females, no clinical signs. The results indicated that scrotal edema accou

Gross pathology:

Dark red lungs, liver with tan patches in one victim. Lungs of one male survivor mottled red. In male survivors, trachea with red patches and lungs discoloured. Gross pathological exady revealed scrotal swelling on 4 of 4 rabbits dosed with the test material, and 2 of 4 rabbits dosed with methanol. The scrotal tissue had a gelatinous appearance on the cut surface. Many of the histopathologic findings were common to both treatment groups. The presence of spermatozoa in the epididymides was more prevalent in the methanol dosed rabbits. Scrotal edema and the lymphangiectasis of the scrotal skin were somewhat more common to the silane dosed animals. Epidermal serofibrinious exudate, epidermal bacterial colonies and increased dermal acidophilis were observed among rabbits treated with the test substance but not in those receiving methanol.
In females, no remarkable findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value for acute dermal toxicity is reported to be 16 ml/kg for males and >16 ml/kg (equivalent to 15520 mg/kg) for female rabbits in a reliable study conducted according to a protocol similar to OECD Test Guideline 402 but which is not compliant with GLP.