Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 11, 1978 - April 28, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test procedure is not based on guideline, but it is comparable with OECD Guideline 401. Though the detailed description of method and the discussion of the result is missing, the study was performed in consistent way and it is scientifically acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The study report do not include details on test procedure and test substance. Only male rats were used in the study.

Principles of method if other than guideline:

LD50 test; 4 groups of ten male rats received a single oral gavage of the test substance. Survivors were sacrificed 14 days later. LD50 value was calculated from the mortality data using the method of D.J. Finney. Probit analysis, 2nd Ed., 1952, Cambridge University Press.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium

EC Number:

248-697-2

EC Name:

Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium

Cas Number:

27858-32-8

Molecular formula:

C18H32O8Ti

IUPAC Name:

Bis(ethylacetoacetato‐O1',O3")bis(propan‐2‐olato)titanium

Details on test material:

- Name of test material (as cited in study report): Titanic acid, diacetoacetyl-diisopropyl; Haskell number 11,939
- Lot/batch No.: Tyzor DC MPD 4809, Product code 976070 Lot #1

Test animals

Species:

rat

Strain:

other: Chr:CD

Sex:

male

Details on test animals or test system and environmental conditions:

No details on test animals and environmental conditions available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
no vehicle was used

MAXIMUM DOSE VOLUME APPLIED:
Dose (mg/kg) Average dose (ml)
29 000 6,52
25 000 5,58
20 000 4,68
17 000 3,96

DOSAGE PREPARATION (if unusual): Test material was administered, as received, without any preparation

Doses:

17 000, 20 000, 25 000, 29 000 mg/bw

No. of animals per sex per dose:

10 males / dose

Control animals:

no

Details on study design:

The test material, as received, was administered by intragastric intubation to four groups of ten young adult male rats in single dose.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Animals were weighed at the initiation of the study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and body weight

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

23 020 mg/kg bw

Based on:

test mat.

Mortality:

Dose (mg/kg) Mortality ratio
29 000 10/10
25 000 5/10
20 000 1/10
17 000 2/10

Clinical signs:

other: Dose (mg/kg) Clinical signs 29 000 Ataxia, lethargy, rapid and labored respiration, gasping, prostration, salivation, lacriation, stained mouth and weight loss after dosing at 29 000 mg/kg 25 000 Ataxia, lethargy, belly-to-cage posture, rapid and labo

Gross pathology:

not done

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Acute toxicity of bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium was determined by using test method equal to OECD 401. LD50 value was 23 020mg/kg of body weight measured by administering test substance as a single oral dose to male rats.

Executive summary:

This study was regarded reliable with restrictions since only male rats were used in this study. Furthermore, the study report does not contain all details of test animals and the study do not include all details on test substance, test method and results. However, the study was performed in a consistent way and it is scientifically acceptable.

In this study, Bis(ethyl acetoacetato-O1',O3)bis(propan-2 -olato)titanium was administered as a single oral dose by intragastric intubation to male rats. Clinical signs of toxicity were observed in all dosed animals. Under the conditions of this test, the LD50 was 23 020 mg/kg of body weight. By the study report this substance is considered to have very low toxicity.

The result of this study would lead to no classification for acute oral toxicity according to EU Regulation No. 1272/2008 (CLP).