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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

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:

yes

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: approximately 2.5 kg
- Housing: individually in clean, stainless steel cages
- Diet: standard Purina Rabbit Chow, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
not specified (temperature, humidity and light controlled room)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal body surface area of the trunk
- % coverage: approximately 10
- Type of wrap if used: semiocclusively with a cotton cloth bandage taped to the hair

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: frequently after dosing and twice daily thereafter
- Frequency of weighing: on days 7 and 14
- Necropsy of survivors performed: yes (complete gross necropsy)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed throughout the study period.

Clinical signs:

other: No behavioural effects were observed throughout the study period.

Gross pathology:

There were no test article related alterations noted at gross necropsy at study termination.

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 investigated for acute dermal toxicity in a limit test conducted similar to OECD 402, and in compliance with GLP. 5 New Zealand White rabbits per sex received a single dose of the test material at a dose of 2000 mg/kg bw. No mortality occurred and no signs of systemic toxicity were noted throughout the study period. Gross necropsy revealed no substance-related findings. Thus, the LD50 value for acute dermal toxicity was set at >2000 mg/kg bw.