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reaction mass of Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2- hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, disodium salt and Benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[(2-hydroxyethyl)amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]ethenyl]-, disodium salt
EC number: 942-661-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From July 27th to August 19th, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted according to internationally accepted testing guidelines and performed in compliance with Good Laboratory Practice. Justification for read across approach is given in the endpoint summary and in the read across justification report attached to the Section 13 of this dossier.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17th December 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- April 29, 2004
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF))
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland.
- Age at study initiation: 11-13 weeks.
- Weight at study initiation: 174.2 - 199.7 g.
- Fasting period before study: the animals received a single dose of the test item after being fasted for approximately 18 to 19 hours (access to water was permitted). Food was provided again 3 hours after dosing.
- Housing: Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet: pelleted standard Provimi Kliba 3433 rat/mouse mainte-nance diet, batch no. 25/05 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water: community tap water from Füllinsdorf ad libitum.
- Acclimation period: under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: continuously monitored environment with ranges for room temperature 22 ± 3 °C.
- Humidity: between 30-70 % (values above 70 % during cleaning process possible).
- Air changes: 10-15 air changes per hour.
- Photoperiod: automatically controlled light cycle of 12 hours light and 12 hours dark.
- Other: music during the daytime light period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- purified
- Details on oral exposure:
- VEHICLE
Purified water was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the GLP statement of compliance.
DOSE FORMULATION
Dose levels are in terms of the test item. The dose formulations were made shortly before each dosing occasion using a magnetic stirrer, a spatula and an Ultra-Turrax (Janke & Kunkel, D-79219 Staufen) as homogenizers.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight : volume).
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
TREATMENT
- Application volume: 10 ml/kg body weight.
- Rationale: oral administration was considered to be an appropriate application method as it is a possible route of human exposure during manufacture, handling and use of the test item. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 2 goups of 3 female each one.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and viability were controlled daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: all animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 ml/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examinations were performed. No organs or tissues were retained.
- Other examinations performed: clinical signs were daily observed during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- 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 were observed during the course of the study.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Any other information on results incl. tables
MORTALITY / CLINICAL SIGNS
Dose mg/kg bw | Animal N. | Sex | Signs | Test days | |||||||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||||||||
0.5* | 1* | 2* | 3* | 5* | |||||||||||||||||
2000 | 1 | F | No clinical signs | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
2 | F | No clinical signs | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
3 | F | No clinical signs | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
2001 | 4 | F | No clinical signs | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
5 | F | No clinical signs | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
6 | F | No clinical signs | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Key: √ noted
* Examinations were performed approximately 0.5, 1, 2, 3 and 5 hours after treatment.
No clinical signs were evident in any animal during the acclimatization period.
BODY WEIGHTS
Dose mg/kg bw | Animal N. | Sex | Day 1 (treatment) | Day 8 | Day 15 |
2000 | 1 | F | 180.3 | 197.9 | 211.8 |
2 | F | 174.2 | 203.2 | 214.2 | |
3 | F | 199.7 | 222.8 | 233.2 | |
2001 | 4 | F | 176.1 | 199.7 | 212.3 |
5 | F | 176.1 | 204.1 | 218.0 | |
6 | F | 194.2 | 218.5 | 228.3 |
Body weights are presented in grams.
MACROSCOPIC FINDINGS
Dose mg/kg bw | Animal N. | Sex | Mode of death | Findings |
2000 | 1 | F | Scheduled necropsy | No macroscopic findings |
2 | F | Scheduled necropsy | No macroscopic findings | |
3 | F | Scheduled necropsy | No macroscopic findings | |
2001 | 4 | F | Scheduled necropsy | No macroscopic findings |
5 | F | Scheduled necropsy | No macroscopic findings | |
6 | F | Scheduled necropsy | No macroscopic findings |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (female rat) > 2000 mg/kg body weight
- Executive summary:
Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
Conclusion
LD50 (female rat): greater than 2000 mg/kg body weight
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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