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Toxicological information

Acute Toxicity: oral

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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: Study non-GLP and pre-guideline, deviates from current standards. Only males were tested, however the study provides adequate information on acute oral toxicity for regulatory/classification purposes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
LD50 test; 5 groups of 10 males received a single oral gavage dose of the test substance; 14 day post administration observation period.
GLP compliance:
no
Test type:
other: LD50 test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further info (ie batch no) provided

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
Source of animals: Willi Gassner (WIGA), Versuchstierzuchtanstalt, 8741 Sultzfeld
Acclimatisation: 3 to 7 days
Cages: Conventional solid bottom cages
Temperature: 22±2°C
Humidity: 55±10%
Other: ad libitum tap water and standard pelleted rat & mouse feed; 12 hours light/dark; after treatment animals housed 5 per cage.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
single oral gavage
Doses:
4.64, 5.62, 6.81, 8.25 and 10.0 g/kg bw (based on average group body weights)
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
Groups of 10 male Sprague-Dawley rats were administered a single gavage dose of Isopropyltitanate at 4.64, 5.62, 6.81, 8.25 or 10 kg/bw. The test material was administered undiluted. Surviving animals were sacrificed at the end of a 14 day observation period. Observations included clinical signs, lethality, body weights and gross necropsy.
Statistics:
Yes, performed

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
7 500 mg/kg bw
Based on:
test mat.
Mortality:
mortality from 5.62 g/kg
4.64 g/kg - 0/10
5.62 g/kg - 2/10
6.81 g/kg - 3/10
8.25 g/kg - 6/10
10.0 g/kg - 10/10

Clinical signs:
Clinical signs occurred in all groups: reduced or no spontaneous activity or reaction to external stimuli; ataxia; decreased or no upright reflex response; reduced faeces; decreased muscle tone; decreased or no pain reflex; reduced or no corneal or pinna reflexes.
Surviving rats were free from clinical signs from 2 days after dosing.
Body weight:
Surviving rats showed normal bodyweight development.
Gross pathology:
Premature decedents: red patches or stripes on the mucous glands of the stomach, haemorrhaging of the glandular stomach (in one rat), dark red to brownish discoloration of the lungs.
Rats killed at the end of the observation period: one rat showed red focal atelectasis on the left lobe of the lung. There were no findings in the remaining rats.

Applicant's summary and conclusion