Titanium complexes of ethanol and 2-dimethylaminoethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1999-12-31 to 2001-02-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Annex V (B1 tris)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 weeks
- Weight at study initiation: 249 to 279g for males, 207 to 222g for females
- Fasting period before study: overnight fasted
- Housing: group of 3 by sex and by cage in solid-floor polypropylene cages.
- Diet: ad libitum3 to 4 hours after dosing
- Water : ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark /12 hrs light

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.88 ml/kg. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing and taking into account that the specific gravity was 1.064

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for death or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight and gross pathological examination.

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Mortality:

Male: no mortalities
Female: no mortalities

Clinical signs:

other: - In males, there were no signs of systemic toxicity during the study period. - In females, hunched posture was observed during the day of dosing and one day after in all animals. 1 female showed also noisy respiration, increased salivation and red/brown

Gross pathology:

Abnormalities noted at necropsy of one male were enlarged right kidney and reduced left kidney. No other abnormalities were noted .

Other findings:

None

Any other information on results incl. tables

Table 7.2.1/1: signs of reaction to treatment

Clinical signs	No. of rats in groups of 3 showing signs
	Dose (mg/kg b.w.)
	2000
	M	F
Hunched posture	0	3
Noisy respiration	0	1
Increased salivation	0	1
Staining around mouth	0	1

 

Table 7.2.1/2: Weekly Bodyweight changes

Dose level mg/kg b.w	Sex	Bodyweight Gain (g) during Week
		1	2
2000	F	38	18
	F	34	-22
	F	17	60
	M	58	55
	M	56	56
	M	61	31

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortalities were noted in rats treated by oral route with a single dose of 2000 mg/kg bodyweight.
Therefore, the substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.

Executive summary:

The substance was tested for acute oral toxicity according to OECD 423 guideline and in compliance with Good Laboratory Practices.

Groups of rats (3 /sex) were administered by gavage a single dose of the test substance at 2000 mg/kg b.w.. Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period.

No mortalities were observed throughout the study.

In males, there were no signs of systemic toxicity during the study period while hunched posture was observed in all females during the day of dosing and one day after. In addition, 1 female showed also noisy respiration, increased salivation and red/brown staining around the mouth.

Except this female which showed bodyweight loss during the second week of the study, the body weight gain was not affected in the remaining animals.

At necropsy, one male showed enlarged right kidney and reduced left kidney. No other abnormalities were noted.

The combined acute oral LD50 was found greater than 2000 mg/kg bw.