Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five male and five female Wistar rats received a single dose of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) per gavage. The animals were observed for mortality, clinical signs, weight gain for 14 days. A gross pathological examination of after sacrifice at the end of the study was performed.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animals species: Rat / wistar / Dr. Thomae
Animal breeder: Dr. Thomae GmbH
Acclimatisation: At least 1 week
No. animals per dose: 5 male animals and 5 female animals
Type of cage: Stainless steel wire mesh cages, Type DK III
No. animals per cage: 5
Room temperature/ The animals were housed in fully air-conditioned rooms (20 - 24°C; relative humidity 30 - 70°C).
relative humidity
Day/night rhythm: 12 hours / 12 hours
Drinking water: Tap water ad libitum
Diet: Kliba Labordiaet 343
Animals weight: Animals of comparable weight (+/- 20% of the mean weight).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% aqueous carboxymethyl cellulose
Details on oral exposure:
The animals were given no feed 16 hours before administration, but water was available ad libitum.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
no
Details on study design:
Signs and symptoms are recorded several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
Withdrawal of food 16 hours before sacrifice; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Remarks on result:
other: None of the animals died up to the end of the study
Mortality:
None
Clinical signs:
None
Body weight:
Males:
Begin of the test: 191 g
After 7 days: 262 g
After 13 days: 297 g
Females:
Begin of the test: 182 g
After 7 days: 211 g
After 13 days: 226 g
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A dose of 2000 mg/kg bw of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was tolerated without symptoms. None of the animals died.
The LD50 is greater than 2000 mg/kg bw.
Executive summary:

Five male and five female Wistar rats received a single dose of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) per gavage. the animals were observed for mortality, clinical signs, weight gain for 14 days. A gross pathological examination of after sacrifice at the end of the study was performed. None of the animals died during the observation period. No clinical signs and no abnormalities were detected. therefore the LD50 is greater than 2000 mg/kg bw (discriminating dose).