Manganese antimony titanium buff rutile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (purity unknown, non-GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Principles of method if other than guideline:

BASF Test
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage with an aqueous solution of the test substance; the concentration of test substance in vehicle (w/v) was 50% and the application volume was 10 ml/ kg bw.
The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter on day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sicotan Braun K 2711

Cas Number:

68412-38-4

IUPAC Name:

Sicotan Braun K 2711

Details on test material:

no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach, Germany
- Mean weight at study initiation: 169 g (males) and 171 g (females)
- Fasting period before study: 16 h
- Housing: 5 per cage (Stainless steel wire mesh cages)
- Diet: Kliba Labordiaet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Test substance formulation with 0.5% aqueous carboxymethyl cellulose
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium


MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at least once each workday, weighing at d0, d3, d7 and d 13
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: 1% confidence level

Effect levels 2

Sex:

male/female

Dose descriptor:

other: NOAEL

Effect level:

>= 5 000 mg/kg bw

Mortality:

none

Clinical signs:

other: no abnormalities observed

Gross pathology:

no abnormalities observed