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Diss Factsheets

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
Study period:
1984-08-1 to 1984-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Silicophosphonat
IUPAC Name:
Silicophosphonat
Details on test material:
- Name of test material (as cited in study report): Silicophosphonat
- Substance type: Solution
- Composition: 39% in water/NHaOH
- Lot-Nr.: W760/84
- Stability: A contentration control analysis was carried out. The results of these analyses were acceptable.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae GMBH Bieberach
- Weight at study initiation: mean 179 g
- Fasting period before study: 16 hours
- Housing: stainless steel wire mesh cages
- Diet (e.g. ad libitum): not given
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70%
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
conc. (W/V) 50
administered volume 10 mL/kg
application in the morning
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period: 14 days
Recording of signs and symptoms sveral times the day of administration. At least once each workday. Check for moribund and dead animals twice each workday and once on holidays.

Results and discussion

Preliminary study:
In pretests the following doses have been testet: 3160 mg/kg and 1000 mg/kg body weight. No mortality occured.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
none
Clinical signs:
other: no abnormalities
Gross pathology:
no abnormalities
Other findings:
Piloerection on day two

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The LD50 is greater than 5000 mg/kg bodyweight. Silicophosphonate is not toxic under the conditions of this test.
Executive summary:

Silicophosphonat was testet for oral toxicity in 5 male and 5 female rats with a dose of 5000 mg/kg bodyweight . No mortality or other relevant signs of toxicity were noted. The LD50 thus is grater 5000 mg/kg and the substance is practically nontoxic.