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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18th Sept 1989 - 13th Oct 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
12 May 1981
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Titanium 2,2',2''-nitrilotrisethanolate
EC Number:
240-015-1
EC Name:
Titanium 2,2',2''-nitrilotrisethanolate
Cas Number:
15879-01-3
Molecular formula:
C6H15NO3.xTi
IUPAC Name:
titanium 2,2',2''-nitrilotrisethanolate
Test material form:
liquid
Details on test material:
Test Item Name Tyzor TE
IUPAC Name titanium 2,2',2''-nitrilotrisethanolate
CAS No. 15879-01-3
EC No. 240-015-1
Appearance Light yellow liquid
manufactured by Dorf Ketal Speciality Catalyst Pvt Limited




Test animals

Species:
rat
Strain:
other: Bor; WISW (SPF Cpd)
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 190g
- Fasting period before study: No
- Housing: 1-5 animals in Makrolon Typre III cages
- Diet (e.g. ad libitum): ad libitum R10 complete diet for rats
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: 5-8- days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 deg C +/- 1
- Humidity (%): 60% +/- 5
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
3488 mg/kg bw (=3,26 mL / kg bw)
No. of animals per sex per dose:
5 males and 5 females / dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 488 mg/kg bw
Mortality:
no mortalities
Clinical signs:
other: No clinical signs observed in male rats. Female rats showed symptoms between 1 and 3 hours after test item administration. At 4 hours no no adverse effects were observed.
Gross pathology:
No macrosopic findings were observed in 4 male and 2 female animals investigated

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the results of the present study, The LD50 of Titanium 2,2´,2´´nitrilotrisethanolate, Tyzor TE, is 3488 mg/kg.
Executive summary:

The acute oral toxicity study with Titanium 2,2´,2´´nitrilotrisethanolate, Tyzor TE, in rats was conducted to assess the toxicological profile of the test item. The prepared dose formulation was administered as a single oral gavage to overnight fasted (16 to 18 hours) five female and five male rats (G1-FTS) at the dose of 3488 mg/kg body weight. There were mild clinical signs observed on female rats at 1-3 hour post administration. No mortality was observed during the study. The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 7 and 14. Necropsy was performed for 4 male and 2 female rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy. Based on the results of the present study, The LD50 of the test item, Tyzor TE is 3488 mg/kg or classified as Cat5 per the GHS.

The test item does not meet the criteria for classification as “Category 4” (300 mg/kg < Acute Toxicity Estimates ≤ 2000 mg/kg) as per Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labeling and packaging of substances and mixtures.