Registration Dossier

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
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

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
Chemical structure
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:
Squatting posture, irregular respiration, stilted and uncoordinated gait. Impairment of motility and respiration - reversible after 1 day.
Body weight:
Development of body weight was not impaired.
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.