Registration Dossier
Registration Dossier
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EC number: 608-880-3 | CAS number: 335153-21-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(2-formyl-4-nitrophenoxy)hexanoic acid
- EC Number:
- 608-880-3
- Cas Number:
- 335153-21-4
- Molecular formula:
- C13H15NO6
- IUPAC Name:
- 2-(2-formyl-4-nitrophenoxy)hexanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 3 males and 3 females; females were nulliparous and non-pregnant. Group housing/maxi,um of 3 per cage of the same sex. Ambient temperature @20°C with 30-70% humidity. 10-15 air exchanges per hour. 12 hourlight/dark cycle, full spectrum fluorescent lights.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Doses:
- 500mg/kg and 2000mg/kg
- No. of animals per sex per dose:
- 3 male animals dosed at 500mg/kg and then 3 female animals dosed at 2000mg/kg.
- Control animals:
- no
- Details on study design:
- Animals dosed once only.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- discriminating dose
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died at the doses during the observation period of 14 days.
- Clinical signs:
- Piloerection observed folling the 500mg/kg dosing of the male rats. Recovery within 4 days.
Piloerection observed folling the 2000mg/kg dosing of the female rats. Recovery within 8 days. - Body weight:
- All animals gained body weight during the study. The males more so than the females.
- Gross pathology:
- No significant abnormalities were observed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is defined as non-toxic.
- Executive summary:
The test substance is defined as non-toxic based on the absence of mortality and the criteria of the study protocol.
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