Titanium 2,2',2''-nitrilotrisethanolate

Acute Toxicity: oral

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

Test material information

Constituent 1

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.