Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-hydroxyethyl)ammonium 7-{4-[4-(2-cyanoamino-4-hydroxy-6-oxidopyrimidin-5-ylazo)benzamido]-2-ethoxy-phenylazo}naphthalene-1,3-disulfonate
EC Number:
421-440-3
EC Name:
Tris(2-hydroxyethyl)ammonium 7-{4-[4-(2-cyanoamino-4-hydroxy-6-oxidopyrimidin-5-ylazo)benzamido]-2-ethoxy-phenylazo}naphthalene-1,3-disulfonate
Cas Number:
778583-04-3
Molecular formula:
Hill formula: C47 H66 N12 O19 S2 CAS formula: C29 H21 N9 O10 S2 x 3 C6 H15 NO3
IUPAC Name:
tris(tris(2-hydroxyethyl)azanium) 2-(cyanoamino)-5-{2-[4-({4-[2-(6,8-disulfonaphthalen-2-yl)diazen-1-yl]-2-methoxyphenyl}carbamoyl)phenyl]diazen-1-yl}-6-hydroxypyrimidin-4-olate
Test material form:
solid: compact

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., Wölferstr. 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: females: 178-193g; males: 196-210g
- Fasting period before study: about 21h
- Housing: groups of 5 animals in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Kliba 343 rat maintainance diet ad libitum
- Water (e.g. ad libitum): Itingen community tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1996-07-24 To: 1996-08-07

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mg/kg bw
Doses:
limit dose of 2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: 4 times during day 1 and once daily during days 2-15
- Weighting: On days 1 (pre-administration), 8, and 15
- Necropsy of survivors performed: yes
Statistics:
The logit-model for LD50 determination could not be used as no deaths occured.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the physiological range of variability known for rats of this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean lethal dose of the substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. It can therefore be concluded that the LD50 is greater than 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the substance was determined according to OECD Guidelines for Testing of Chemicals, Section 4, Number 401 "Acute Oral Toxicity", adopted February 24, 1987 and Directive 92/69/EEC, B.1. "Acute Toxicity-Oral", July 31, 1992.

A group of five male and 5 female Wistar rats was treated with the substance at 2000 mg/kg bw by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg bw. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

There were no deaths as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the physiological range of variability known for rats of this strain and age. No macroscopic findings were observed at necropsy.

The mean lethal dose of the substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. It can therefore be concluded that the LD50 is greater than 2000 mg/kg bw.