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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2-[4-[[2-cyano-3-[4-[methyl(2-sulphonatoethyl)amino]phenyl]-1-oxoallyl]amino]phenyl]-6-methylbenzothiazole-7-sulphonate
EC Number:
219-694-3
EC Name:
Disodium 2-[4-[[2-cyano-3-[4-[methyl(2-sulphonatoethyl)amino]phenyl]-1-oxoallyl]amino]phenyl]-6-methylbenzothiazole-7-sulphonate
Cas Number:
2498-95-5
Molecular formula:
C27H24N4O7S3.2Na
IUPAC Name:
disodium 2-{4-[(2-cyano-3-{4-[methyl(2-sulfonatoethyl)amino]phenyl}acryloyl)amino]phenyl}-6-methyl-1,3-benzothiazole-7-sulfonate
Test material form:
other: solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight), mean weight: administration 1: 183.3 g, administration 2: 184.0 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: single housing in Makrolon cages, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany; adlibitum (except during fasting period)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs light / hrs dark): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
FORM OF ADMINITRATION: Suspension

VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Justification for choice of vehicle: a good homogeneity in water could not be guaranteed, because the test item preparation was a suspension

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test item was prepared for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally, the homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.

CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw were administered to another group of 3 female animals in the second step.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 x 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: A check for any dead or moribund animals was made at least once each workday
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter
- Necropsy of survivors performed: yes; necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations
- Other examinations performed: clinical signs, body weight
Statistics:
Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
No mortality occurred in both test groups.
Clinical signs:
other: In the first administration group impaired general state and piloerection were observed from hour 1 until hour 3 or 4 in all animals. In the second administration group no clinical signs were observed in all animals during clinical examination.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this study the median lethal dose of the test item after oral administration was found to be greater than 2000 mg/kg bw in rats.
Executive summary:

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the test item (preparations in 0.5% CMC-solution) were administered by gavage to two test groups of three fasted female Wistar rats each.

The following test substance-related clinical observations were recorded, clinical signs occurred within the first 4 hours after administration:

2000 mg/kg (first test group):

- No mortality occurred

- Impaired general state in all animals

- Piloerection in all animals

2000 mg/kg (second test group):

- No mortality occurred

- No clinical signs were observed.

The body weights of both test groups increased within the normal range throughout the study period. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be greater than 2000 mg/kg bw.