Isobutylisopropyldimethoxysilane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 August to 18 August 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to EU Guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isobutylisopropyldimethoxysilane

EC Number:

402-580-4

EC Name:

Isobutylisopropyldimethoxysilane

Cas Number:

111439-76-0

Molecular formula:

Hill formula: C9H22O2Si

IUPAC Name:

dimethoxy(2-methylpropyl)(propan-2-yl)silane

Details on test material:

Batch no. of ZK 119.649: W 87/75-82
Stability of ZK 119.649: At least stable till April/May 1988

Test animals

Species:

rat

Strain:

other: Wistar-Han-Schering

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering
- Age at study initiation: No data
- Weight at study initiation: 92-118 g males, 98-119 g females
- Fasting period before study: 18.5 hours
- Housing: No data
- Diet (e.g. ad libitum): pell. Altromin R
- Water (e.g. ad libitum): No data
- Acclimation period: 6 days (F) or 7 days (M)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°
- Humidity (%): 60-68%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 5 August 1987 To: 18 August 1987

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: isotonic sodium chloride solution

Details on dermal exposure:

Single dermal application of 2.18 g ZK 119.649/kg body weight

Vehicle:
Isotonic sodium chloride solution
Dose: 2.5 mL/kg
1L contains 9.0 g sodium chloride
Batch no. KL 150 A2
Stable till June 30, 1990
Manufacturer: Fresenius, Bad Homburg, FRG

Duration of exposure:

24 hours

Doses:

2.18 g/kg body weight

No. of animals per sex per dose:

3 males + 3 females per dose

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes. On day 14 of the test all surviving animals were sacrificed.
- Other examinations performed: clinical signs, body weight

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 180 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: other: None

Gross pathology:

No substance-related findings on autopsy.

Other findings:

No local findings.

Any other information on results incl. tables

Body weight in g at the start (day 1), day 8 and at the end (day 14) of the test:

Dose (g/kg)	No. of animals, sex	Animal no.	Day 1 (X/SD)	Day 8 (X/SD)	Day 14 (X/SD)
2.5 ml/kg vehicle (control)	3M/3F	1M	110/111	144/111	185/17
		2M
		3M
		1F	111/7	135/9	152/12
		2F
		3F
2.18	3M/3F	4M	98/6	132/7	167/9
		5M
		6M
		4F	99/1	126/1	140/1
		5F
		6F

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of ZK 119.649 after a single dermal application in rats (M+F) is > 2.18 g/kg body weight.

Executive summary:

The acute dermal toxicity of the test substance was determined in accordance with EU Guidance.

The LD50 of ZK 119.649 after a single dermal application in rats (M+F) is > 2.18 g/kg body weight.