Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 277-552-6 | CAS number: 73612-29-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 277-552-6
- EC Name:
- Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 73612-29-0
- Molecular formula:
- C18H14N2O6S.Sr
- IUPAC Name:
- strontium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Physical state: powwder, red
- Analytical purity: the test substance has not been fully characterized analytically.
- Lot/batch No.: CS-485
- Stability under test conditions: has not been determined analytically.
- Storage condition of test material: room temperature
- Name of test material (as cited in study report): LITHOL RUBIN D 4569-SR-LACK, Substance number 91/3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR . K . THOMAE GMBH, 7950 BIBERACH, BRD
- Age at study initiation: YOUNG ADULT ANIMALS
- Mean weight at study initiation: 150 - 300 g +- 20%
- Fasting period before study: AT LEAST 16 HOURS, WATER WAS AVAILABLE AD LIBITUM .
- Housing: SINGLE HOUSING.
- Diet (e.g. ad libitum): KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG 4303 KAISERAUGST, SWITZERLAND , AD LIBITUM .
- Water (e.g. ad libitum): TAP WATER AD LIBITUM PER DAY
- Acclimation period: AT LEAST 1 WEEK
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 H/12 H
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous tylose solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 22 g/100 mL, 0 .5% solution of Tylose CB 30.000 in Aqua Bidest.
- Justification for choice of vehicle: Aqueous formulation corresnponds to the physiological medium.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 2200 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Frequency of observations for signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once ach workday for the individual animals.
- Frequency of general observations and mortality: check was made twice each workday and once on mortality: Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.
- Frequency of weighing: individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: Yes, necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before euthanisation with CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 mg/kg bw
- Mortality:
- No mortality observed
- Clinical signs:
- other: No abnormalities observed
- Gross pathology:
- No pathologic findings noted
- Other findings:
- Skin coloured red, discoloured feces (red) at day 1, noted in all animals
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
