Registration Dossier
Registration Dossier
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EC number: 265-723-8 | CAS number: 65380-84-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Nov - 05 Dec 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Bis[2-[(2-aminoethyl)amino]ethanolato][2-[(2-aminoethyl)amino]ethanolato-O](propan-2-olato)titanate
- EC Number:
- 265-723-8
- EC Name:
- Bis[2-[(2-aminoethyl)amino]ethanolato][2-[(2-aminoethyl)amino]ethanolato-O](propan-2-olato)titanate
- Cas Number:
- 65380-84-9
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- 2-methyl-4,4-bis(propan-2-yloxy)-3,5-dioxa-8-aza-4-titanadecan-10-amine; 7,7-bis(propan-2-yloxy)-6,8-dioxa-3,11-diaza-7-titanatridecane-1,13-diamine; 7,7-bis({2-[(2-aminoethyl)amino]ethoxy})-6,8-dioxa-3,11-diaza-7-titanatridecane-1,13-diamine; 7-{2-[(2-aminoethyl)amino]ethoxy}-7-(propan-2-yloxy)-6,8-dioxa-3,11-diaza-7-titanatridecane-1,13-diamine; tetrakis(propan-2-yloxy)titanium
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Raleigh, North Carolina, USA
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 – 9 weeks
- Weight at study initiation: 194 – 203 g
- Fasting period before study: Yes, the animals were fasted 16 – 20 h prior to test article administration.
- Housing: Individually, in suspended wire-bottom cages with absorbent paper bedding.
- Diet: certified Rodent LabDiet® No. 5002, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- 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: 0.30 - 0.32 mL/rat
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females (the animals were dosed sequentially)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed twice daily for mortaility and at 15 min, 1, 2 and 4 h post-dosing and once daily thereafter for 14 days for signs of toxicity and pharmacological effects. Observations included, but were not limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (e.g., self-mutilation, walking backwards).
- Frequency of weighing: Body weights were recorded pre-test, weekly and at termination.
- Necropsy of survivors performed: Yes, all animals were examined for gross pathology.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Chromorhinorrhea was observed in 1/5 animals 1 h after administration. The effect was reversible within 2 h after administration and not considered treatment-related.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: No classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- CLP: not classified
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