Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 5th to December 25th, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test conducted according to internationally accepted testing guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)

EC Number:

289-142-4

EC Name:

Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)

Cas Number:

86024-59-1

Molecular formula:

C33H24ClCuN9O15S4.3Na

IUPAC Name:

Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[4-[[2(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo] -4-sulphobenzoato(6-)]cuprate(4-)

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Inc. (Hino Breeding Center, Shiga, Japan).
- Age at study initiation: six-week old.
- Weight at study initiation: 221 -239 g for males; 164 - 183 g for females.
- Fasting period before study: fasting period about 20 hours before the dosing and 4 hours after the dosing.
- Housing: two or three animals of the same sex were placed in a suspended aluminium cage with wire-mesh floor (floor 22.4 cm x 41.9 cm, height 20.0 cm; YAMATO Scientific Co., Ltd., Tokyo, Japan). The cage and tray were changed at least once and twice weekly, respectively.
- Diet: rats were fed laboratory animal chows (CRF-1 sterilized by 60Co at 30 kGy, pellet type, Oriental Yeast Co., Ltd., Tokyo, Japan), ad libitum.
- Water: tap water passed through a filter apparatus, ad libitum except for the 4 hours after dosing.
- Acclimation period: quarantine and acclimatization period of 11 days.

ENVIRONMENTAL CONDITIONS
- Temperature:24 ± 2 °C
- Humidity: 55 ± 15 %
- Air changes: more than 10 times per hour.
- Photoperiod: 12 hours light/dark cycle by fluorescent lighting system.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Dosing volume: 10.0 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: observation of clinical signs and mortality was carried out at 10 and 30 minutes, 1, 2 and 4 hours after administration and once daily for 2 weeks thereafter. Each animal was weighed on Days 0, 7 and 14 during the observation period.
- Necropsy of survivors performed: yes. At the end of observation period, all animals were exsanguinated from the abdominal aorta under pentobarbital anaesthesia, and were necropsied for gross pathological examination.

Statistics:

Analysis of variance in one way classifications was performed for mean body weight and mean body weight gain. With regard to the parameters in which a significant difference was found at the 5 % level, the least significant difference (LSD) method was used as a test for significant difference compared with the control group.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No dead animals were found in any groups.

Clinical signs:

other: Fecal excretion of blue substance was observed in males and females at 2000 mg/kg. This clinical sign appeared 4 hours after dosing and disappeared within 3 days.

Gross pathology:

Retention of white substance in the urinary bladder was found in both control and treated groups. There was no treatment-related finding in the gross pathological examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

LD50 (rat) (males/females) > 2000 mg/kg bw

Executive summary:

Acute oral toxicity of the test substance was examined in rats at the dosage of 2000 mg/kg in both sexes. The test material was suspended in distilled water at the concentration of 200 mg/ml, and orally administrated at 10.0 ml/kg body weight. None of the animals employed in the experiment died. Fecal excretion of blue substance was observed in both sexes at 2000 mg/kg. The mean body weight gain on day 0 to day 7 at 2000 mg/kg males V was lower than that of control. No treatment-related findings were observed by gross pathological examination.

Conclusion

LD50 (rat) (males/females) > 2000 mg/kg bw