Registration Dossier
Registration Dossier
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EC number: 218-427-8 | CAS number: 2150-46-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 2,5-dihydroxybenzoate
- EC Number:
- 218-427-8
- EC Name:
- Methyl 2,5-dihydroxybenzoate
- Cas Number:
- 2150-46-1
- Molecular formula:
- C8H8O4
- IUPAC Name:
- methyl 2,5-dihydroxybenzoate
- Test material form:
- solid: crystalline
- Details on test material:
- Almost white crystalline powder
Lot 17110801
Retesting date: 2020-11-07
Constituent 1
- Specific details on test material used for the study:
- White crystalline powder
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean 180g range 175 to 189 g
- Fasting period before study: 16h
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known: SPF
- Method of randomisation in assigning animals to test and control groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C;
- Humidity (%): 30-70%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Oct 19 2020 To: Nov 10 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No rat died during the observation period.
- Clinical signs:
- other: Clinical signs in the first 2000 mg/kg test group revealed in all animals impaired general state, dyspnoea and piloerection from hour 2 until hour 5 after administration. Cowering position was observed in two animals from hour 3 until hour 5, while diarrh
- Gross pathology:
- No adverse findings observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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