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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-02-06 to 1991-02-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
EEC Directive 84/449 EEC, EEC Publication No. L251, September 1984
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide
EC Number:
915-069-0
Molecular formula:
not applicable
IUPAC Name:
Reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: males 186-208 g, females 152-166 g
- Fasting period before study: Feed was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 5 animals per sex per cage in polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by Broekman Institute, Someren, The Netherlands).
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55 %
- Air changes (per hr): 15
- Photoperiod: Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
DOSE VOLUME APPLIED: 20 mL/kg body weight
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
-- Mortality/Viability: At periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
-- Body weights: Days 1 (pre-administration), 8 and 15
-- Symptoms: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin, fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: mortality: 0/10
Mortality:
No animal died during the study period.
Clinical signs:
No clinical signs of ill health or behavioural changes were seen during the study.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities that were considered to have arisen as an effect of treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: Regulation (EC) No 1272/2008 (EU GHS)
Conclusions:
According to CLP Regulation (EC) No 1272/2008, a classification for acute oral toxicity of substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is not required and labelling is not necessary.
Executive summary:

In an acute oral toxicity study according to OECD Guideline No. 401, adopted February 1987 and EEC Directive 84/449/EEC, Part B.1, September 1984, groups of fasted, approximately 8 weeks old male and female Wistar rats were given a oral single dose of substance " reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) in polyethylene glycol at a dose of 5000 mg/kg bw (limit test) by gavage and observed for 14 days.

Oral LD50 Males and Females > 5000 mg/kg bw.

No animal died during the study period. No clinical signs of ill health or behavioural changes were seen during the study. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities that were considered to have arisen as an effect of treatment.

Substance " reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" (90 % a.i.) is of low toxicity based on the oral LD50> 5000 mg/kg bw in male and female rats.