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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:
1980
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

Constituent 1
Chemical structure
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)

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:
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.
Body weight:
Dose group: Increase of body weight was affected by the treatment in the first week.
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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