N-[3-(trimethoxysilyl)propyl]butylamine

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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)

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

Details on test material:

- Name of test material (as cited in study report): Silane 44-42 (organofunctional), Dynasylan 1189
- Physical state: yellow liquid
- Lot/batch No.: 09989

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-5 months
- Fasting period before study: none
- Diet: appropriate diet ad libitum (not further specified)
- Water: ad libitum (not further specified)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess fluid was removed to prevent ingestion (not further specified)
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2, 4, 8, and 16 mL/kg bw, equivalent to 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:

4 animals (not further specified)

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, skin irritation

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:

not specified

Dose descriptor:

LD50

Effect level:

15 200 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 187.5 - <= 193 800

Remarks on result:

other: (equivalent to 16.0 ml/kg bw (95% CL 1.25 -204 ml/kg bw); calculated based on a density of 0.95 g/cm³)

Effect levels 2

Sex:

not specified

Dose descriptor:

LD0

Effect level:

1 900 mg/kg bw

Based on:

test mat.

Remarks on result:

other: (equivalent to 2.0 ml/kg bw; calculated based on a density of 0.95 g/cm³)

Mortality:

- 16 ml/kg bw: 2/4 (both deaths occured on day 3)
- 8 ml/kg bw: 1/4 (animal died on day 11 post-dosing); repeated for confirmatory purpose: deaths 2/4 (animals died on days 2 and 3)
- 4 ml/kg bw: 1/4 (animal died on day 2 post-dosing)
- 2 ml/kg bw: 0/4

Clinical signs:

other: - 16 ml/kg bw: Erythema, oedema, necrosis, ecchymosis, fissuring, desquamation at 14 days; Prostrate at 1 day - 8 ml/kg bw: Erythema, oedema, ecchymosis, scabs at 14 days; repeated for confirmatory purpose: Oedema, necrosis at 24 h, scabs on survivors at

Gross pathology:

In victims, the lungs were red, the livers mottled bright red and tan, the kidneys were found to be mottled tan and red, the spleens appeared dark, the stomacs were injected or opaque.
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 dermal toxicity according to a test protocol that is comparable to the appropriate OECD 402 test guideline, but without GLP compliance. The test material was occlusively administered to 4 rabbits each dose group. The LD50 was determined to be 15200 mg/kg bw. The predominant clinical signs detected were signs of irritation/corrosion, such as erythema, oedema, and necrosis. No deaths occured at 1900 mg/kg bw, but still signs of skin irritation were noted. Based on this data, classification for acute dermal toxicity according to Regulation (EC) No. 1272/2008 is not warranted.