Registration Dossier
Registration Dossier
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EC number: 609-664-1 | CAS number: 393-85-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA: OPPTS 870.3050, Health effects test guidelines: repeated dose 28-day toxicity study in the rodents, July 2000
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 5-Fluoro-2-nitrobenzoic acid methyl ester
- EC Number:
- 609-664-1
- Cas Number:
- 393-85-1
- Molecular formula:
- C8H6FNO4
- IUPAC Name:
- 5-Fluoro-2-nitrobenzoic acid methyl ester
- Test material form:
- other: amber liquid
- Details on test material:
- purity: 96.6 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age of the animals: approximately 6 weeks, animal Identification: tattoo number on the tail, fur marking and cage marking, in transparent macrolon cages, room temperature: 22+/-3°C, relative humidity: 50+/-20 % , food: sniff R/M-H (V1534) ad libitum, acclimatisation: at least 5 days, tap water: in plastic bottles ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Duration of treatment / exposure:
- 29 days, 28 application
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 62.5, 250 or 1000 mg/ kg bw
Basis:
- No. of animals per sex per dose:
- 5 animals per sex and group
- Control animals:
- yes
Examinations
- Other examinations:
- Clinical observation performed and frequency: General health conditions: twice daily (weekend, puplic holiday once),clinical symptoms of toxicity: once daily
- Statistics:
- 1-way ANOVA with a two sided ordinal step down trend test.
Results and discussion
Results of examinations
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- but no statistically significant effect (weight gain in the high dose group was slightly lower)
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- but no statistically significant effect; alkaline phosphatase activity
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- slight but STATISTICALLY SIGNIFICANT decrease in PH value in the high dose group.
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- No statistically significant increase.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The relative liver weight is STATISTICALLY SIGNIFICANT increased in the intermediate and in the high dose group.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In conclusion, repeated administration of 5-Fluoro-2-nitrobenzoic acid methyl ester at a dose level of 62.5 mg/kg bw per day did not cause any substance related alterations. The dose level 250 mg/kg bw did not cause any adverse alterations, while there is a slight evidence that the dose level 1000 mg/kg bw might cause marginal adverse effects to the liver. Acute oral toxicity testing of 5-Fluoro-2-nitrobenzoic acid methyl ester at a dose of 2000 mg/kg in the rat (limit test) showed that the median lethal dose (LD50) is above 2000 mg/kg body weight in both male and female animals.
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