Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May 1998 to 10 June 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed in accordance with valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate
EC Number:
428-480-0
EC Name:
Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate
Cas Number:
214559-61-2
Molecular formula:
C26H24N6O13S6Na4
IUPAC Name:
tetrasodium 7-{2-[4-({4,6-bis[(3-sulfopropyl)sulfanyl]-1,3,5-triazin-2-yl}amino)-3-methoxyphenyl]diazen-1-yl}naphthalene-1,3-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: solid
- Appearance: orange coloured granulous powder
- Storage condition of test material: room temperature and protected from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 6 weeks
- Weight at study initiation (mean ± standard deviation): 186 ± 4 g (males); 139 ± 10 g (females)
- Fasting period before study: overnight (approximately 18 hours before dosing). Food was returned to cages 4 hours after dose administration.
- Housing: polycarbonate cages covered with a stainless steel lid. Each cage contained 4 - 7 animals of the same sex during acclimatisation period and 5 animals of the same sex during the treatment period.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 27 May 1998 to 10 June 1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
(purified)
Details on oral exposure:
The test material was prepared in the vehicle at a concentration of 2000 mg/kg bw. It was administered to the animals under a volume of 10 mL/kg. The administration was performed in a single dose by oral route using a metal gavage tube fitted to a 2 mL glass syringe. The volume administered to each animal was adjusted according to body weight determined on the day of treatment.
Doses:
2000 mg/kg bw
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: animals were observed frequently during the hours following administration and then at least once daily thereafter
- Frequency of weighing: bodyweight measurements were taken on the day of administration (day 1) and on days 8 and 15
- Necropsy of survivors performed: yes, by CO2 asphyxiation
- Other examinations performed: macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. In case of macroscopic lesions, organ samples were taken and preserved in 10 % buffered formalin.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
The body weight gain of the animals was not influenced by treatment.
Gross pathology:
Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Any other information on results incl. tables

Test animals

- Source: Iffa Crédo, 69210 L'Arbresle, France

- Diet: A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was therefore determined to be in excess of 2000 mg/kg bw. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The acute oral toxicity of the test material was determined in accordance with standardised guidelines EU Method B.1 and OECD 401. During the study rats received a sinlge oral dose of 2000 mg/kg under a volume of 10 mL/kg. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days following administration of the test material. A necropsy was performed on each animal at study termination. Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was therefore determined to be in excess of 2000 mg/kg bw.