Registration Dossier
Registration Dossier
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EC number: 209-077-7 | CAS number: 554-95-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October to November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Limit Test: Test animals were administered a single dose of 16000 mg/kg bw of test substance.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Benzene-1,3,5-tricarboxylic acid
- EC Number:
- 209-077-7
- EC Name:
- Benzene-1,3,5-tricarboxylic acid
- Cas Number:
- 554-95-0
- Molecular formula:
- C9H6O6
- IUPAC Name:
- benzene-1,3,5-tricarboxylic acid
- Test material form:
- solid
- Details on test material:
- Benzene-1,3,5-tricarboxylic acid manufactured by Chemische Werke Hüls AG Marl (1980)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Sprague-Dawley, SPF
- Source: W. Gassner, Sulzfeld (Germany)
- Weight at study initiation: females 110-125 g, males 110-135 g (mean) Environmental conditions:
- Feed: R 10 complete feed for rats (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Illumination: 12 hour light/dark rhythm
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 %
- Details on oral exposure:
- - Single dose after 16 h of fasting, feeding 4 hours after administration
- Volume: 40 ml/kg b.w. (CMC 0.5%)
- Dosage Preparation: 40% suspension in 0.5% CMC
- Concentration: 16 g/kg Kgw - Doses:
- 16 000 mg/kg b.w. (gavage),
- No. of animals per sex per dose:
- control group: 5 male and 5 female
dose group: 5 male and 5 female - Control animals:
- yes
- Details on study design:
- - Post dose observation period: 14 days
EXAMINATIONS:
- body weight: before and on days 1, 7, 14 after treatment
- clinical signs: up to 6 hours after treatment, then daily
- gross pathology at the end of investigation - Statistics:
- not neccessary
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 female rat of dose group died between 24h and 48h after administration
- Clinical signs:
- other: Control group: Piloerection up to 5 hours after adminstration Dose group: Piloerection up to 72 hours after adminstration Signs of toxicity had disappeared after 72 hours.
- Gross pathology:
- no findings
- Other findings:
- no further information
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Conclusions:
- In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item is greater than 16000 mg/kg body weight.
- Executive summary:
The test item was given to rats by oral administration (40 ml/kg b.w) to obtain information on the toxicity, in particular lethality, of the test item.
The vehicle was administrated to 5 male and 5 female Spague-Dawley rats. Test item was administrated as 40% suspension in CMC (0.5%) oral to 5 male and 5 female Spague-Dawley rats. Dose level of 16000 mg/kg b.w. was employed.
One female rat of dose group died between 24h and 48h after administration.
Animals of control group showed Piloerection up to 5 hours after adminstration, animals of dose group showed Piloerection up to 72 hours after adminstration. There were no signs of toxicity after 72 hours.
The increase of body weight of dose group animals was affected by the treatment in the first week.
Dissection at the end of the experiment showed no findings.
Under the conditions of this study the acute toxicity after oral application is greater than 16000 mg/kg bw.
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