Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Sep 1998 to 13-Nov-1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Amendment to Protocol: location of the animals changed, additional "Study-Coordinator" was nominated and Tap water from Füllinsdorf and Itingen was presented to the animals
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/CEE, B.1
GLP compliance:
yes (incl. QA statement)
Remarks:
Switzerland GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
EC Number:
429-070-4
EC Name:
reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
Cas Number:
214362-06-8
Molecular formula:
C26H(25-y-x)KyN5NaxO16S5 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO22S7
IUPAC Name:
octapotassium octasodium 7-amino-4-hydroxy-3,8-bis(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3,8-bis(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
Test material form:
solid: particulate/powder
Details on test material:
Test item name: Reactive Brown 49
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TVR 50
- Expiration date of the lot/batch: September 01, 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature (approx. 20 °C) away from direct sunlight.
- Stability of the test substance in the vehicle: Stable in bi-distilled water for at least 24 h

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source : RCC Ltd, Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414 Füllinsdorf/ Switzerland
Number of animals per group : 3 males and 3 females
Age when treated : Males 8 weeks ; females 10 weeks.
Body weight range when treated : Males: 173.9 - 209.1 g ; Females : 168.4 - 175.9 g
Identification : By unique cage number and corresponding color-coded spots on the tail.
Acclimatization : One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study
Diet: Pelleted standard Kliba 3433, batch nos. 25/98 and 28/98 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to intubation). Results of analyses for contaminants are archived at RCC.
Water: Community tap water from Füllinsdorf (September 28 to October 23, 1998) and Itingen (October 23 to 29, 1998), available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 38 - 66
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12-h artificial fluorescent light, 12-h dark cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled water
Doses:
2000 mg/kg diluted in bi-distilled water at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The purpose of this study was to assess the acute oral toxicity of FAT 40'571/A when administered by single oral gavage to rats, followed by an observation period of 14 days. This study should provide a rational basis for risk assessment.
The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment.
The preparation was made shortly before each dosing.
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 17 to 21 h, but with free access to water. Food was provided again approximately 3 to 4 h after dosing.
Dose / kg body weight: 2000 mg
Application volume/kg body weight : 10 ml
Rationale Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article.
OBSERVATIONS
Mortality / Viability Four times during test day 1 and once daily during days 2 to 15.
Body weights On test day 1 (pre-administration), 8 and 15.
Clinical signs Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
Statistics:
No statistical analysis was used 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.
Mortality:
Male and female: 0
Clinical signs:
other: No clinical signs were observed during the observation period in females. In males excretion of red feces caused by test article was noted on days 2 and 3 only.
Gross pathology:
No effects on organs were seen.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose (LD50) of FAT 40'571/A after single oral administration to rats is greater than 2000 mg/kg body weight.
Executive summary:

An acute oral gavage toxicity study was carried out with FAT 40571/A according to OECD 401 guideline in Male and female Wistar rats at the dose level of 2000 mg/kg bw. There were no no clinical signs were observed during the observation period in females except in males, excretion of red feces caused by test article was noted on days 2 and 3 only. There waas no mortality and gross lesions found. There was no treatment related effects on body weight.

Based on the study results and absence of mortality, the median lethal dose (LD50) of FAT 40'571/A after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.