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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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- Fasting period before study: Food was withdrawn the evening before application and was offered again about 3 hours after application.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 Exception: Food was withdrawn the evening before applica tion and was offered again about 3 hours after application.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:
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.
Body weight:
Body weight gain was inconspicuous and comparable to untreated animals.
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.

These results can be assigned to lead silicate since a read across based on a grouping of substances (Pb substances) is applied.