Tetra-n-butyl titanate, polymer with water

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 4, 2012 - January 24, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in accordance with OECD No. 423 guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions.

Test guideline 5

Qualifier:

according to guideline

Guideline:

other: As required by the Dutch Act on Animal Experimentation (February 1997), this type of protocol was reviewed and agreed by the Laboratory Animal Welfare Officer and the Ethical Committee (DEC 03-42)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetra-n-butyl titanate, polymer with water

EC Number:

500-687-1

EC Name:

Tetra-n-butyl titanate, polymer with water

Cas Number:

162303-51-7

Molecular formula:

not applicable (UVCB substance

IUPAC Name:

tetraethoxytitanium

Test material form:

other: Viscous liquid

Details on test material:

- Name of test material (as cited in study report): Tetra-n-butyl titanate, polymer with water
- Molecular formula (if other than submission substance): Not applicable as the substance is an UVCB
- Physical state: Yellow viscous liquid
- Analytical purity: unknown
- Lot/batch No.: 304-300137/000060
- Expiration date of the lot/batch: 21 may 2014
- Stability under storage conditions: stable
- Storage condition of test material: At room temperature in the dark
- Other:
Hygroscopic: Yes, store in well-sealed container
Reactivity: Reactive to moisture
Specific Gravity: 1.12 at 25ºC
Stability in vehicle: Stable at least six hours
Solubility in vehicle: Suspension

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 11-12 weeks old)
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 degrees C
- Humidity (%): 40 to 70
- Air changes (per hr): 15 room air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hours dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Kaydoll mineral oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at WIL Research Europe and on test substance.

MAXIMUM DOSE VOLUME APPLIED: 2000mg/kg BW

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Total 6 animals and per group 3 animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

Statistics:

No data

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured (Table 1 in attached background material)

Clinical signs:

other: Lethargy, hunched/flat posture, slow breathing and/or uncoordinated movements were noted among the animals on Day 1. (Table 2 in attached background material)

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals (Table 4 in attached background material)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The oral LD50 value of tetra-n-butyl titanate, polymer with water in Wistar rats was established to exceed 2000 mg/kg body weight.

The substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Executive summary:

Tetra-n-butyl titanate, polymer with water was administered as an oral gavage in female rats to evaluate acute toxicity. The test substance did not cause any deaths during the study period and thus the LD50 value was concluded to be > 2 000 mg/kg body weight under the conditions of this study.

Based on these results, Tetra-n-butyl titanate, polymer with water does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

This study was regarded reliable without restrictions since the study was conducted in accordance with OECD No. 423 guideline and in compliance with GLP.