Trilead bis(carbonate) dihydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

Aug. 1989-Oct. 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well-documented and corresponded to the requirements of the recommended Annex V test guidelines

Justification for data waiving:

other:

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetralead trioxide sulphate

EC Number:

235-380-9

EC Name:

Tetralead trioxide sulphate

Cas Number:

12202-17-4

Details on test material:

- Name of test material (as cited in study report): Tribasic lead sulphate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institut fur Versuchstierzzucht, A-2325 Himberg, Austria
- Age at study initiation: approx. 9 weeks at time of administration
- Weight at study initiation: See table below
- Fasting period before study: Food was withdrawn the evening before application and was offered again about 3 hours after application.
- Housing: Single caging in Makrolon cages type II (16.5 cm x 22 cm x 14 cm). Wire mesh lids. Grid floors till 7d p.a.
- Diet (e.g. ad libitum): Altomin 1314 ff, gamma irradiated with 10kGy 60 Co, ad libitum. Exception: Food was withdrawn the evening before applica tion and was offered again about 3 hours after application. Random samples of the food are analysed for contaminants by Altromin, D-4937 Lage.
- Water (e.g. ad libitum): tap water, UV-sterilised, ad libitum, offered in Makrolon bottles with stainless steel canules.
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 23 degrees
- Humidity (%): average of 55%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): artificial light from 6AM to 6 PM


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% Na-Carboxymethylcellulose aqueous swelling.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test substance was suspended in a 1% Na-Carboxymethylcellulose aqueous swelling.

Doses:

5000 mg/kg b.w.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Behavior, reactions and physical signs of the animals were observed approximately 1, 10, 30 min, 1, 2, 4 and 6 hours after administration (p.a.) and then at least once a day for 2 weeks.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Changes were recorded. Body weight was determi ned before administration, 7 days p.a. and 14 days p.a. All animals were sacrificed by C02 14 days p.a. and examined macroscopically in an attempt to identify the target organs.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No animal died spontaneously during the study. The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight.

Clinical signs:

other: All animals showed raised fur and slightly decreased motor activities from about 4 hours p.a. to 9 days p.a. at the longest. Arched back was observedin animal No. 6 f between one and 4 days p.a. No other adverse effects were noted during observation time.

Gross pathology:

No abnormal findings were noted at post mortem examination.

Any other information on results incl. tables

This report was reviewed by the Quality Assurance Unit. The reported methods and procedures were found to describe those used and the results to constitute an accurate representation of the data recorded.

Acute oral toxicity of Austrostab 133 in rats. Limit-test. Synopsis of the results.

sex	dose (mg/kg)	number of dead/affected/exposed animals
male	5000	0/5/5
female	5000	0/5/5

Acute oral Toxicity of Austrostab 133 in rats. Observations in Life

Finding	No. of the animal affected	observation time p.a. first	observation time p.a. last
motor activities slightly decreased	1m	6h	1d
	2m	4h	1d
	3m	4h	1d
	4m	4h	1d
	5m	4h	1d
	6f	4h	4d
	7f	4h	1d
	8f	4h	1d
	9f	4h	1d
	10f	6h	1d
arched back	6f	1d	4d
raised fur	1m	6h	8d
	2m	4h	4d
	3m	4h	4d
	4m	4h	4d
	5m	1d	1d
	6f	1d	3d
	7f	1d	4d
	8f	4h	4d
	9f	6h	4d
	10f	4h	4d

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight Criteria used for interpretation of results: other: OECD-Guideline 401

Conclusions:

The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight.

Executive summary:

It was the aim of this study to reveal acute toxic effects of AUSTROSTAB 133 after a single oral administration of 5000 mg test substance per kg body weight. AUSTROSTAB 133 is a stabilizer.

Austrostab 133 was administered perorally to 5 male and 5 female Sprague Dawley rats once at a dose of 5000 mg test substance per kg body weight. The test substance was suspended in a 1 % Na-Carboxymethylcellulose aqueous swelling. Methods and investigations performed were in conformance with OECD-Guideline 401.

Results:

Toxic signs in life: Signs of reduced well-being in all animals were slightly decreased motor activities and raised fur. Onset of signs was approximately 4 hours p.a. No other toxic effects were noted during in life observations.

Mortality: All animals survived till the end of the study.

Post Mortem Examination:

At post mortem examination 14 days after administration no lesions were detected.

LD50 (oral):

The LD50 (oral) is higher than 5000 mg Austrostab 133 per kg body weight.