Aluminium trititanium dodecachloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-12-18 to 2004-02-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

December 17, 2001

Deviations:

not specified

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Titanium trichloride

EC Number:

231-728-9

EC Name:

Titanium trichloride

Cas Number:

7705-07-9

Molecular formula:

Cl3Ti

IUPAC Name:

Titanium trichloride Titanium(III) trichloride

impurity 1

Reference substance name:

unknown impurities

IUPAC Name:

unknown impurities

Test material form:

solid: granular

Details on test material:

Purity: 99.6%

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:Tosoh FInechem Corp., Lot No,;THP1031
- concentration: 0.3 and 0.5 wt% in olive olil.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:Stable under inert atmosphere.
- Stability under test conditions:Not known
- Solubility and stability of the test substance in the solvent/vehicle:Not known

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles river Japan
- Females (if applicable) nulliparous and non-pregnant: [yes/no] Yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 211 g (207,1 - 218.6 g)
- Fasting period before study: Overnight
- Housing:Stainless steel net floor cages (260W x 300D x 150H mm)
- Diet (e.g. ad libitum): ad libitumm
- Water (e.g. ad libitum):ad libitu
- Acclimation period:9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2004-01-06 To:2004-01-29

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5 and 3.0%
- Amount of vehicle (if gavage):10 mL/kg
- Justification for choice of vehicle:good dispesion property
- Lot/batch no. (if required):
- Purity:

Doses:

50 mg/kg, 300 mg/kg

No. of animals per sex per dose:

Female 5 per gruop

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:observation; 10 min, 30min, 1h, 2h, 3h and 4 h on administration day. Twice on the next day. after that observation was conducted once a day until 14th day after administration.
Weighing: 1,7,14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

not used

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 mg/kg bw

Based on:

test mat.

Mortality:

Both groups (50 mg/kg and 300 mg/kg) did not show death after single oral treatment during whole (14 days post-treatment period) experiment. (Tabel 1)

Clinical signs:

10 minutes after administration of substance, all animals in 300 mg/kg showed decreased spontaneous locomotion and three of them showed decreased respiratory rate and incomplete eyelid opening. These symptoms became to disapear after 3 hours and completely disappeared after one day. In addition, one animal in 50 mg/kg group showed mucous stool.
This mucous stool was transient change after administration. As this symptom was sometimes observed by administration of olive oil, this observation was seemed to be due to administration of medium (olive oil).

Body weight:

all animals showed expected gains in body weight.

Gross pathology:

No abnormalities were observed at necropsy.

Any other information on results incl. tables

Table 1 Acute oral toxicity study in rats

Mortality

Sex	Exp group (mg/kg)	Number of deaths on day																						Mortality
		0								1	2	3	4	5	6	7	8	9	10	11	12	13	14(day)
		0^a)	5	10	30 (min)	1	2	3	4(h)
Female	50	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5^b)
	300	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5^b)

a)   Immediately after administration

b)   Number of dead animals/Number of animals

 

Table 2 Acute oral toxicity study in rats

Summary of clinical signs

Signs	Female
	50	300	mg/kg
	ta	ta
	5^a)	5
No abnormalities detected	4
Decreased spontaneouslocmotion		5
Decreased respiratory rate		3
Incomplete eyelid opening		3
Mucous stool	1

ta, terminal autopsy

a)   Number of animals examined

 

 

Table 3 Acute oral toxicity study in rats

Summary of body weights (g)

Sex	Exp. Group (mg/kg)	Number of animals	Observation period
			0	1	7	14	(day)
Female	50	5	188.4	210.4	230.5	247.5
			±2.3	±3.5	±13.5	±17.5
	300	5	192.7	207.6	231.6	254.1
			±4.6	±5.4	±4.2	±10.9

     Mean ± S.D.

 

Table 4 Acute oral toxicity study in rats

Summary of macroscopic examination

Findings	Female
	50	300	(mg/kg)
	ta	ta
	5^a)	5
No abnormalities detected	5	5

  ta, terminal autopsy.

   a) Number of animals examined.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The acute oral median lethal dose (LD50) of the substance in the female rat was estimated to be greater than 300 mg/kg bodyweight.

Executive summary:

The acute oral median lethal dose (LD50) of the substance in the female rat was estimated to be greater than 300 mg/kg bodyweight.