Diiron titanium pentaoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 February 1990 - 29 March 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diiron titanium pentaoxide

EC Number:

234-679-1

EC Name:

Diiron titanium pentaoxide

Cas Number:

12023-27-7

Molecular formula:

Fe2O5Ti

IUPAC Name:

titanium(4+) diiron(3+) pentaoxidandiide

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Chbb:THOM

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: mean initial weight 182 (172-196) g
- Fasting period before study: rats did not receive any food from 17 h before up to 4 hours after treatment
- Housing: treated rats were kept separately in Makrolon cages type III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 26
- Humidity (%): 38 - 45
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous 0.25% hydroxypropyl methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 g ad 100 mL
- Amount of vehicle: 20 mL/kg
- Justification for choice of vehicle: solubility

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

Control: 0 mg/kg bw
Treatment group: 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Behavior and general condition of all rats were monitored for 4-6 hours after administration and then checked daily. All rats were weighted before treatment, as well as on days 2,4,6,8,11,13 and 15 of the study.
- Necropsy of survivors performed: yes

Statistics:

The bw data were processed by means of the program TOX 511 A.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during this study.

Clinical signs:

other: No clinical findings were observed.

Gross pathology:

Gross pathology did not reveal any abnormalities in rats treated the test material.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the discriminating dose in rats after single oral administration was > 5000 mg/kg body weight.

Executive summary:

The acute toxicity potential of the test item was evaluated following single oral administration to male and female Wistar rats at a dose level of 5000 mg/kg bw in aqueous 0.25% hydroxypropyl methylcellulose. No deaths were observed during the study. No clinical signs were observed after application up to the end of the 15 -day observation period. Body weight gain of the treated rats was unaffected. Gross pathology did not reveal any abnormalities.

Based on the results of this study, the maximum non-lethal dose of the test material in rats after single oral administration is >5000 mg/kg bw, and Diiron titanium pentaoxide is considered to have no toxic potential after single administration by the oral route.