Registration Dossier
Registration Dossier
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EC number: 939-526-9 | CAS number: 90506-73-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read across from GLP study, tested with the source substance Potassium hexadecyl hydrogen phosphate. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- as adopted December 17, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- as adopted April 29, 2004
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium hexadecyl hydrogen phosphate
- EC Number:
- 242-768-1
- EC Name:
- Potassium hexadecyl hydrogen phosphate
- Cas Number:
- 19035-79-1
- IUPAC Name:
- potassium hexadecyl hydrogen phosphate
- Reference substance name:
- 19035-79-1 (Potassium hexadecyl hydrogen phosphate)
- IUPAC Name:
- 19035-79-1 (Potassium hexadecyl hydrogen phosphate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Herlan Winkelmann GmbH
- Age at study initiation: 6lo 10 weeks
- Weight at study initiation: 183 g
- Fasting period before study: not given
- Housing: 3 animals per cage, transparent macrolon cages (type IV) on soft wood granulate
- Diet: ssniff R/M-H (V1534) ad libitum
- Water: tap water in plastic bottles ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 08.03.2005 to 22.03.2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:20 % suspension of test substance in sesame oil
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity: according to supplier 100 %
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: based on toxicity data of related compounds - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: symptoms recorded twice daily, weekly weighting
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- no
- Clinical signs:
- other: no
- Gross pathology:
- nomacroscopically vlslble changes
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- LD50 for female animals exceeds 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method), adopted 17 December 2001 and EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method), 6 female fasted, 6 to 10 weeks old Hsd Sprague Dawley (SD) rats were given a single oral dose of Potassium hexadecyl hydrogen phosphate (100% a.i.) in sesame oil at a limit dose of 2000 mg/kg bw and observed for 14 days. There were no deaths. No signs of systemic toxicity were noted. All animals showed expected gains in bodyweight over the observation period. No abnormalities were noted at necropsy. Oral LD50 females > 2000 mg/kg bw
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