Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-818-1 | CAS number: 13497-18-2
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Jan - 27 June 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 1981
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Bis(triethoxysilylpropyl)amine
- EC Number:
- 236-818-1
- EC Name:
- Bis(triethoxysilylpropyl)amine
- Cas Number:
- 13497-18-2
- Molecular formula:
- C18H43NO6Si2
- IUPAC Name:
- bis(triethoxysilylpropyl)amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, Borchen, Germany
- Age at study initiation: 7-8 weeks (males), 9-10 weeks (females)
- Weight at study initiation: 130-178 g (males), 132-162 g (females)
- Fasting: 16 h prior to dosing
- Housing: individual housing in Makrolon cages (type II)
- Diet: ssniff R, (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 12.1 ml/kg bw
- Doses:
- 2506, 5395, 11616 mg/kg bw (2.61, 5.62, 12.1 ml/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (for 21 days for animal no. 6)
- Frequency of observations and weighing: The rats were observed for 4-8 h post-dose on day of appplication and once (clinical signs) or twice (mortality) daily thereafter. Body weights were obtained on the day of treatment and on day 7 and 14 (and 21 for animal 6).
- Necropsy of survivors performed: yes (major organ systems of the thoracic and abdominal cavities were examined for all animals)
- Histopathology of macroscopic findings was performed (fixation in formalin) - Statistics:
- Probit analysis for LD50 calculation
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 580 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 288 - 6 325
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 657 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 333 - 7 287
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 6 106 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 167 - 12 716
- Mortality:
- 2506 mg/kg bw: 1/5 males (day 3) and 0/5 females
5395 mg/kg bw: 4/5 males (day 1-2) and 2/5 females (day 1-4)
11616 mg/kg bw: 5/5 males (day 1-3) and 5/5 females (day 1) - Clinical signs:
- other: 2506 mg/kg bw: Males: reduced locomotor activity, shivering of the head, reduction of muscle tone, nasal discharge, salivation, piloerection, cyanosis, labored breathing, abnormal gait, cavernous flanks, reduction of body weight Females: reduced locomotor
- Gross pathology:
- 2506 mg/kg bw: mottled liver (1 animal)
5395 mg/kg bw: red coloured glandular stomach (focal erosion) and intestinal mucosa, mottled liver, pale kidney with punctual spots
11616 mg/kg bw (1 animal): red coloured glandular stomach (focal erosion) and intestinal mucosa, mottled liver, pale kidney with punctual spots - Other findings:
- 2506 mg/kg bw: tubular hyperplasia in 3/5 animals (in one animal: tubular dilatation, necrosis, hypertrophy, interstitial fibroplasia, secondary glomerulonephrosis and protein cylinder)
5395 mg/kg bw (1 animal): liver necrosis with liver cell hypertrophy and focal pigment deposits, necrosis in the kidney and deposits of basophile material
11616 mg/kg bw (1 animal): cell degeneration and necrosis in the liver, oval cell hyperplasia, necrosis in the kidney and deposits of basophile material
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:
- In an acute oral toxicity study conducted according to OECD 401, a LD50 of 3657 mg/kg bw was derived in rats. In the low dose group 1/5 males and 0/5 females were found dead. Treatment with 5395 mg/kg bw led to 4/5 dead males and 2/5 dead females within day 1-2 and 1-4, respectively. All animals were found dead after treatment with 11616 mg/kg bw on days 1-2. In conclusion, a combined LD50 of 4580 mg/kg bw was calculated. The LD50 for males and females were 3657 and 6106 mg/kg bw, respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
