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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
11 July 2001 - 30 July 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and it was compliant with GLP. The study is read across from the calcium sodium salt of DTPMP (CAS 52871-36-0).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
52871-36-0
Cas Number:
52871-36-0
IUPAC Name:
52871-36-0
Constituent 2
Reference substance name:
DTPMP Ca Na
IUPAC Name:
DTPMP Ca Na
Details on test material:
- Name of test material (as cited in study report): SPE 9806

- Physical state: amber liquid

- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: ca 8 weeks
- Weight at study initiation: minimum of 200 g
- Fasting period before study: overnight and for ca. 3 hours after dosing
- Housing: individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 - 70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.61 ml/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily. Individual body weights were recorded prior to dosing on day 0 and on days 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The gross pathological examination consisted of an external examination and opening of the abdominal and thoracic cavities. The appearances of any macroscopic abnormalities were recorded. No tissues were retained.

Results and discussion

Preliminary study:
A range finding study was performed with 2000 mg/kg dose at 1.61 ml/kg dose volume, using 1 male and 1 female animal. The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2and 4 hours after dosing and subsequently once daily for 5 days. No necropsies were performed. Based on the results of the range finding study a further group of animals was treated.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
An acute oral toxicity LD50 value of >2000 mg/kg is reported in a guideline study which us conducted in compliance with GLP. The result is read across from the calcium/sodium salt of DTPMP (CAS 52871-36-0).