Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-01-30 to 1991-02-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24 Feb. 1987
Deviations:
no
GLP compliance:
yes
Remarks:
The study report states that the study was conducted in compliance with OECD Principles of Good Laboratory Practice (Bundesanzeiger Nr. 42a, of the 2nd of March 1983 and Bundesgesetzblatt, Part I, of the 22nd of March 1990.
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Titanium oxide sulphate
EC Number:
237-523-0
EC Name:
Titanium oxide sulphate
Cas Number:
13825-74-6
Molecular formula:
O5STi
IUPAC Name:
titanium oxide sulphate
Details on test material:
- Name of test material (as cited in study report): Titanium oxide sulfate
- Physical state: brown liquid
- Stability under test conditions: Analytic investigation regarding the stability of the test substance in the vehile showed that the test substance was stable during the exposure period.
- Storage condition of test material: closed bottle

No further significant information on test material was stated.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeder Winkelmann, Borchen
- Age at study initiation: according to the weight of the rat, the rats were ca. 8 (males) to 10 (females) weeks old
- Weight at study initiation: males had an average weight of 187 g; females had an average weight of 171 g
- Fasting period before study: Approx. 16 hr
- Housing: Groups of 5 in type III macroloncages with dust free wood granulate (Ssniff, Soest/Westfalen).
- Diet (ad libitum): fixed-formula standard diet Altromin 1324 pellets 8Altromin GmbH and Co KG, Lage)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Relative humidity: approx. 50 +/- 10%
- Air changes: approx. 10/hr
- Photoperiod (hrs dark / hrs light): 12/12

No further significant information on test animals was stated.


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
No further significant information on oral exposure was stated.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of application the animals were observed a couple of times. During the observation period the animals were observed twice each day (once on weekends and holidays). The animals were weighed directly before test substance administration, after one week and at the end of the observation period.
- Necropsy of survivors performed: Yes.
- Other examinations performed: The beginning, duration and intensity of clinical signs were recorded and if needed dead animals were removed. All animals that died during the experiment and animals that were killed with diethyl ether anaesthesia in the end of the experiment were pathological examined.
No further significant information on study design was stated.
Statistics:
Since only one dose level was used the LD50 was estimated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: The LD50 was exactly determined. See Statistik above.
Mortality:
One female rat died 4 hours after dosing of the test substance.
Clinical signs:
Rats dosed with 2000 mg/kg bw suffered from piloerection and apathy. The symptoms were of minimal intensity to medium intensity and were observed about 30 minutes after dosing of the test substance. Generally, the symptoms were seen for up to 8 hours after dosing. One male showed slight piloerectionon the following day after dosing of the test substance. On the third day of the study all animals were free of symptoms.
Body weight:
The body weight of the surviving animals was not effect.
Gross pathology:
The female, which died during the study, showed in some places of the fundus of the stomach blackish coloured stomach mucosa. The mucosa of the small intestine was reddened. In all other animals nothing was found during the pathological examination.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A LD50 > 2000 mg/kg bw was stated for male and female rats. Titanium oxide sulfate was considered as nontoxic. According to the directive 67/584/EWG and regulation (EC) 1272/2008 (CLP) titanium oxide sulfate does not need to be classified.
Executive summary:

This study on acute oral toxicity with target chemical titanium oxide sulphate followed the protocol as given by OECD Guideline 401. Propylene glycol was used as vehicle. The LD50 was determined to > 2000 mg/kg bw. According to the EU classification systems CLP and DSD no classification of the substance as to its acute oral toxicity properties applies.