Registration Dossier
Registration Dossier
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EC number: 231-203-4 | CAS number: 7446-26-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Jan 2017-07 Feb 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted 08 February 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Gesundheit und Soziales, Mecklenburg-Vorpommern, Germany
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Dizinc pyrophosphate
- EC Number:
- 231-203-4
- EC Name:
- Dizinc pyrophosphate
- Cas Number:
- 7446-26-6
- Molecular formula:
- H4O7P2.2Zn
- IUPAC Name:
- dizinc(2+) (phosphonooxy)phosphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Other: white, odourless
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories GmbH, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks (test group 1), 10 weeks (test group 2)
- Weight at study initiation: 204.7 - 242.0 g
- Fasting period before study: overnight prior to dosing
- Housing: group housed by dose, not further specified
- Diet: conventional laboratory diet pellets, ssniff Spezialdiaten GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 January 2017 To: 07 February 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 1 mL/100 g bw
- Justification for choice of vehicle: suspension was formed in the vehicle
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Information about toxicity provided by the Sponsor indicated that the test material was likely non-toxic at this dose level. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours and daily thereafter for a total of 14 days. Individual weights of animals were determined shortly before the test substance was administered, and weekly thereafter.
- Necropsy of survivors performed: yes - Statistics:
- BW changes and LD50 values were calculated.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: According to this study, an LD50 cut-off of 5000 mg/kg was used.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- No clinical signs of toxicity were observed at dosing or up to the end of the 14-day observation period.
- Body weight:
- No animals showed any adverse effect on body weight gain.
- Gross pathology:
- Necropsy examination revealed no substance-related or abnormal findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The LD50 of dizinc pyrophosphate is >2000 mg/kg bw by the oral route of exposure in female Wistar rats, and therefore the material is not classified.
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