Registration Dossier
Registration Dossier
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EC number: 277-288-1 | CAS number: 73138-39-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Aug 2004 - 16 Sep 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 1996
- Deviations:
- yes
- Remarks:
- , lack of details (test substance, animals, housing)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- , the study was conducted in 2004 following the guideline adopted in 1996, although the guideline had been updated in 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 1996
Directive N° 96/54/EC
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des produits chimiques, Paris, Republique Francaise
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, coco, esters with 1,3-butanediol
- EC Number:
- 277-288-1
- EC Name:
- Fatty acids, coco, esters with 1,3-butanediol
- Cas Number:
- 73138-39-3
- Molecular formula:
- not applicable, the substance is UVCB
- IUPAC Name:
- Fatty acids, coco, esters with 1,3-butanediol, UVCB
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: not stated
- Purity test date: not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: not stated
- Weight at study initiation: 181g to 196g (males) and 168g to 185g (females)
- Fasting period before study: not stated
- Housing:not stated
- Diet: A04 Rat and mouse maintenance diets
- Water: not stated
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 55-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
IN-LIFE DATES: From: 24 August 2004 To: 08 September 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: none
MAXIMUM DOSE VOLUME APPLIED: 2.19 mL/kg body weight
ROUTE OF ADMINISTRATION: oral gavage (using a suitable syringe graduated fitted with an oesophageal metal canula) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Remarks:
- Distilled water at 2 mL/kg bw
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily from day 1 to day 14
- Frequency of weighing: day 0, day 2, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs at 1, 3, and 5 hours after oral administration on day 0
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test product were observed.
- Gross pathology:
- The macroscopical examinations of the animals at the end of the study did not reveal treatment-related changes.
- Other findings:
- No abnormalities regarding spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lacrimation, righting reflex, back hair appearance assessed at 1, 3, and 5 hours after oral administration.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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