Registration Dossier
Registration Dossier
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EC number: 202-723-9 | CAS number: 99-04-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- m-toluic acid
- EC Number:
- 202-723-9
- EC Name:
- m-toluic acid
- Cas Number:
- 99-04-7
- Molecular formula:
- C8H8O2
- IUPAC Name:
- m-toluic acid
- Test material form:
- solid: granular
- Details on test material:
- -Appearance: colorless to pale yellow
-Molecular weight: 136.15
-Melting point: 111.7 °C
-Boiling point: 263 °C
- soluble in organic solvents, almost insoluble in vegetable oils, sparingly water soluble
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: sealed at a cool (4 °C) and dark place
- Stability under test conditions: stable during use period
- Solubility and stability of the test substance in the solvent/vehicle: uniform administration solution in 1 % methylcellulose in water
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dissolved in 1 % methylcellulose in water
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5 weeks
- Weight at study initiation:
males:
mean body weight at time of administration: 134 g (range: 127 - 138 g)
females:
mean body weight at time of administration: 116 g (range: 110 - 120 g)
- Fasting period before study: approximately 12.5 hours
- Housing: in stainless steel wire mesh cages, separated by sex
acclimation period: three rats were co-housed,
after administration: two to three rats were co-housed
- Diet ad libitum: obtained from Nosan Kako Co., Ltd., Japan, national type feed laboratory MR stock, Lot No. 97.12.61 (assumed)
- Water ad libitum: sterile tap water irradiated with ultraviolet rays
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22 °C
- Humidity (%): 52 - 59 %
- Air changes (per hr): 10 times or more per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1 % in aqueous solution
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1 mL/kg bw
- Doses:
- 0, 1000 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 males/ 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations were carried out 1, 3 and 6 hours after administration and daily thereafter until day 14.
Weighing was carried out shortly before administration and on days 1,3,7 and 14 after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights - Statistics:
- The LD50 could not be calculated because no lethality occurred.
Results and discussion
- Preliminary study:
- 3 males and 3 females per group were exposed to doses of 1000, 2000 and 4000 mg/ kg bw. One male of the 4000 mg/ kg bw dose group displayed weak acute toxicity.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- no effects observed
- Body weight:
- no effects observed
- Gross pathology:
- no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male and females rats) > 2000 mg/kg bw
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via 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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