Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Study conducted prior to the adoption of OECD test guidelines.
Deviations:
yes
Remarks:
Level of report detail does not meet current standards.
GLP compliance:
no
Remarks:
Study was conducted prior to GLP.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Etidronic acid
EC Number:
220-552-8
EC Name:
Etidronic acid
Cas Number:
2809-21-4
Molecular formula:
C2H8O7P2
IUPAC Name:
(1-hydroxyethane-1,1-diyl)bis(phosphonic acid)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not specified
- Females (if applicable) nulliparous and non-pregnant: Not specified
- Age at study initiation: Not specified
- Weight at study initiation: from 225 to 270 g
- Fasting period before study: Not specified
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: Not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
The test substance was administered by gavage (dosing volumes not stated, as a 50% aqueous solution).   No details about the range-finding study, test conditions or observation schedule are provided.  
Doses:
2000, 2510, 3160 and 3980 mg/kg bw
No. of animals per sex per dose:
3 females and 2 males at 2000 mg/kg bw
3 females and 2 males at 2510 mg/kg bw
2 females and 3 males at 3160 mg/kg bw
2 females and 3 males at 3980 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: Clinical signs of toxicity observed for, but duration not stated.
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of the viscera of animals that died.
Statistics:
LD50 calculated by a modification of the method of E.J. de Beer (no further details).  Calculation was not presented in study report.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 130 mg/kg bw
Based on:
test mat.
95% CL:
> 2 660 - < 3 665
Remarks on result:
other: presumed equivalent to 1878 mg active acid/kg bw
Mortality:
No death was observed at 2000 mg/kg bw. One female died at 2510 mg/kg bw. Two male and one female rats died at 3160 mg/kg bw. Two male and two female rats died at 3980 mg/kg bw. Survival time was one to eight hours with most deaths occurring in one to two hours.
Clinical signs:
Toxic symptoms included weakness followed by dyspnoea and collapse.
Body weight:
No data.
Gross pathology:
At autopsy there was inflammation of the gastric mucosa and haemorrhagic areas in the lungs.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In a well conducted acute oral study (reliability score 2), conducted using a protocol similar to the now deleted OECD 401, but not to GLP, an LD50 of 3130 mg/kg bw was determined for the test substance (60% HEDP-H) in the rat (reviewer of IUCLID comment: presumed equivalent to 1878 mg active acid/kg bw) .

Categories Display