Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-[3-(triethoxysilyl)propyl]oxolane-2,5-dione

IUPAC Name:

3-[3-(triethoxysilyl)propyl]oxolane-2,5-dione

Constituent 2

Reference substance name:

Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione

EC Number:

297-566-6

EC Name:

Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione

Cas Number:

93642-68-3

Molecular formula:

C13H24O6Si

IUPAC Name:

3-[3-(triethoxysilyl)propyl]dihydrofuran-2,5-dione

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 weeks
- Weight at study initiation: male: 184-210 g; female: 174-187 g
- Fasting period before study: withdrawal of food from about 16 hours before to 3-4 hours after treatment
- Housing: macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil (Oleum sesami DAB 10)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% solution
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: symptoms recorded twice daily (morning and afternoon), only once on weekends and public holidays; weighed weekly
- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: Squatting posture, irregular respiration, stilted and uncoordinated gait. Impairment of motility and respiration - reversible after 1 day.

Gross pathology:

Narrowed palpebral fissure. No macroscopically visible changes at necropsy.

Any other information on results incl. tables

Table 1: Mean body weights

Dose	Mean body weight (g) on day
Substance mg/kg bw	1	8	15	1	8	15
	Males			females
2000	209	262	315	187	216	228
2000	184	226	252	174	203	221
2000	210	278	315	176	204	220
2000	196	259	288	179	205	222
2000	196	240	275	187	232	257

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione has been tested in an acute oral toxicity study conducted according to OECD 401 and in compliance with GLP. The test substance was diluted with sesame oil prior to administration of 2000 mg/kg bw by gavage to 5 male and 5 female rats. The animals showed impairments of motility and respiration as well as narrowed palpebral fissure. Symptoms were reversible 1 day after application. No mortalities occurred. The LD50 was determined to be >2000 mg/kg bw.