Registration Dossier
Registration Dossier
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EC number: 902-882-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD Guideline acute toxicity study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- Batch No. S-122009-311853
Purity: 100%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age: 8-12 weeks
Acclimatisation period: 5 days
Housing: up to 4/cage
Temperature: 19 - 25 degrees C
Humidity: between 30-70 % RH
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Once by gavage using metal cannula attached to a graduated syringe. Volume was calculated based on body weight at the time of dosing.
- Doses:
- 300 or 2000 mg/kg
- No. of animals per sex per dose:
- 300 mg/kg: 1 rat
2000 mg/kg: 5 rats - Control animals:
- no
Results and discussion
- Preliminary study:
- A single animal was dosed with 300 mg/kg and survived with hunched posture observed on the day of dosing. The following day the animal appeared normal. Based on this result, a dose level of 2000 mg/kg was investigated.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal out of five was killed for humane reasons due to pronounced clinical signs.
- Clinical signs:
- Hunched posture (4 animals); decreased respiratory rate and laboured respiration (1 animal).
- Body weight:
- One animal showed body weight loss during the first week.
- Gross pathology:
- In the animal that was sacrificed for humane reasons, abnormally red lungs, dark liver and kidneys, and gaseous stomach and intestines were observed.
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Fuel-A presents a low acute toxicity hazard by the oral route.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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