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EC number: 230-237-7 | CAS number: 6976-37-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol
- EC Number:
- 230-237-7
- EC Name:
- 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol
- Cas Number:
- 6976-37-0
- Molecular formula:
- C8H19NO5
- IUPAC Name:
- 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 199 - 201 g
- Fasting period before study: 1 day
- Housing: group caging (3 rats/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10mL/kg bw
- Justification for choice of vehicle: standard vehicle
- Lot/batch no. (if required):
- Purity: aqua purificata Ph.Hg. VIII. from Parma Produkt Kft.
MAXIMUM DOSE VOLUME APPLIED: 2 mL
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Selection was based on the basis of the available information about the test item and similar substances - 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: rats were observed at least twice daily and weighted on days 0, 7 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, appearance of tissue and organs - Statistics:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg bw: 0 of 6
- Clinical signs:
- other: none
- Gross pathology:
- no changes found
- Other findings:
- none
Any other information on results incl. tables
In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423.
All six female rats treated with 2000 mg/kg bw by oral gavage survived the observation period of 14 days, showing no clinical signs, no pathological changes and normal body weight development.
According to the results of this study the substance is not classified for acute toxicity according to CLP-Regulation (EC) No 1272/2008.
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