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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
EC Number:
701-238-4
Cas Number:
29329-71-3
Molecular formula:
HEDP-2Na C2H6Na2O7P2 HEDP-3Na C2H5Na3O7P2
IUPAC Name:
Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
Test material form:
solid - liquid: aqueous solution

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:
- Females nulliparous and non-pregnant: Not specified
- Rationale for use of males: N/a
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Fasting period before study: Not specified
- Housing: Animals were kept in 3 Makrolon cages, individually housed.
- Historical data: Not specified
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Not specified
- Microbiological status when known : Not specified
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): As recommended in the guideline
- Humidity (%): As recommended in the guideline
- Air changes (per hr): As recommended in the guideline
- Photoperiod (hrs dark / hrs light): As recommended in the guideline

IN-LIFE DATES: Not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2510, 3160, 3570, 3980 mg/kg at 20ml/kg
No. of animals per sex per dose:
10 females in total
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 550 mg/kg bw
Remarks on result:
other: equivalent to 2925 mg/kg bw/day active acid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study, conducted to a protocol similar to the now deleted OECD Test Guideline 401 and pre-GLP, HEDP (2-3Na) was administered by oral gavage to female rats. An LD50 of 3550mg/kg which is equivalent to 2925 mg/kg bw/day active acid was concluded.