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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 04, 1994 - January 18, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1992
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium bis[(3'-nitro-5'-sulfonato-(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
EC Number:
418-220-4
EC Name:
Trisodium bis[(3'-nitro-5'-sulfonato-(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
Molecular formula:
C52H32CrN18Na3O20S4
IUPAC Name:
chromium(3+) trisodium bis(6-amino-2-{4-[2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]benzenesulfonamido}-5-[2-(3-nitro-2-oxido-5-sulfophenyl)diazen-1-yl]pyrimidin-4-olate)
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wñlferstrasse 4, CH-4414 Füllinsdorf/Switzerland
- Age at study initiation: males at 8 weeks; females at 10 weeks
- Weight at study initiation: males at 195.4 - 212.1 g; females at 166.1 - 177.6 g
- Fasting period before study: the animals were fasted for 16 to 22 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
- Diet: pelleted standard Kliba 343. Batch nos. 86/93 and 87/93 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for over-night fasting period prior to application).
- Water: community tap water from Fülllnsdorf, available ad libitum.
- Acclimation period: one week under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.
- Identification: by unique cage number and corresponding color-coded spots on the tail.
- Randomization: randomly selected at time of delivery Into groups of five

ENVIRONMENTAL CONDITIONS
- Temperature: continuously monitored environment with a temperature of 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 ACH
- Photoperiod: 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
TREATMENT
- Application volume/kg body weight: 10 ml/kg
- Rationale: oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article.
Doses:
2000 mg/kg bw, single dose
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: four times during test day 1 (according to the raw data the last check was conducted 5 hours after appilcation) andonce dally during days 2-15.
- Body weights frequency: en test day 1 (pre-adminlstration), 8 and 15.
- Other examinations performed: each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15.
- Necropsy: necropsies were performed by experienced prosectors. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight and sacrificed by exsanguination. The animals were examined macroscopically.
Statistics:
The LOGIT-model could not be applied as no deaths occurred.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Value not quantified since higher than tested concentrations
Mortality:
No deaths occured.
Clinical signs:
No clinical signs of toxicity.
Body weight:
The body weight was not affected.
Gross pathology:
The macroscopic examination of the animals at terminal necropsy revealed no organ abnormalities.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 (males and females) > 2000 mg/kg b.w.
Executive summary:

The test article was administered to a group of 5 male and 5 female rats by oral gavage, at the maximal single dose of 2000 mg test article/kg body weight.

- No deaths occurred during the study period.

- No clinical signs of toxicity were observed during the observation period.

- The body weight was not affected during the observation period.

- The macroscopic examination of the animals at terminal necropsy revealed no organ abnormalities.

In conclusion, the mean lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because no deaths occurred at the maximal dose of 2000 mg test article/kg body weight.