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EC number: 309-269-1 | CAS number: 100208-66-0
- 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
Endpoint summary
Administrative data
Description of key information
The LD50 of the test item in the rat was found to be >2000 mg a.i./kg bw (corresponding to > 3640 mg/kg bw test item).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 07, 2016-March 16, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17th December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008 May 30
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Storage conditions: room temperature, 20 ± 5 °C
Expiration date: 16.06.2020
Correction factor: 1.82 - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:WI rats
Source: TOXI COOP ZRT. Cserkesz u. 90.
1103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The Wistar rats as a rodent is one of the standard species of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8 weeks old in first and second step
Body weight range
at starting (first step): 211 - 214 g
Body weight range
at starting (second step): 208 - 213 g
Acclimatization time: 6 days in the first step and 7 days in the second step
Housing: Group caging (3 animals/cage)
Cage type: Type II polypropylene/polycarbonate.
Bedding: Laboratory bedding.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: above 10 air exchanges/hour by central air-condition system.
Animals received ssniff® SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany and tap water from municipal supply, as for human consumption from bottle ad libitum.
In life phase:January 11-27, 2017 - Route of administration:
- oral: gavage
- Vehicle:
- other: Aqua purificata Ph.Hg. VIII.
- Details on oral exposure:
- All doses were formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 mg/mL. The correction factor was taken into consideration in the course of the making of solution. Formulations were prepared just before the administration and were stirred continuously during the treatment.
Vehicle:
Name: Aqua purificata Ph.Hg. VIII.
Batch number: 1608-5511
Date of expiration: 11.02.2017
Produced by: Parma Produkt Kft.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. The dose refers to the dye content (55 %, correction factor of 1.82) and corresponds to 3640 mg product/kg bw. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 (presented in Appendix VII) was met. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg bw : 6 female animals
- Control animals:
- no
- Details on study design:
- Duration of observation period after the treatment: 14 days
Frequency of observations:
Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter.
Body weight measurement:
The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
Necropsy:
At the end of the observation period all surviving rats were necropsied.
No death occurred after the single 2000 mg/kg bw oral dose of Brown 3.
There were no toxic clinical signs or any treatment related effects of the test item found in body weights and body weight gains during the study. Autopsy revealed no treatment related pathological changes. - Statistics:
- No statistics was used in the study.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No death occurred at 2000 mg/kg bw single oral dose of Brown 3.
- Clinical signs:
- No treatment related symptoms were observed throughout the 14-day post-treatment period.
- Body weight:
- The mean body weight of animals treated with 2000 mg/kg bw dose corresponded to their species and age throughout the study.
- Gross pathology:
- No pathological changes were found related to the treatment with the test item during the macroscopic examination of animals treated with 2000 mg/kg bw dose.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test item after single oral application was found to be >2000 mg a.i./kg bw (corresponding to 3640 mg/kg bw test item).
- Executive summary:
To assess the acute oral toxicity of the test item in rats, the acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg a.i./kg bw (corresponding to 3640 mg/kg bw test item) as the starting dose in three female rats. No animal died in the first step at 2000 mg a.i./kg bw dose level, so treatment with 2000 mg a.i.kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. The animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on day 15 after the treatment. No mortality and no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of the experimental animals were normal. The body weight development was unaffected in all animals. All organs of the animals treated with 2000 mg a.i./kg bw proved to be free of treatment related gross pathological changes. The LD50 was found to be >2000 mg a.i./kg bw corresponding to >3640 mg test item/kg bw.
Reference
A single oral administration - followed by a fourteen-day observation period was performed by gavage. The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.
The starting dose was selected on the basis of the available information about the test item.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 were met.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral:
To assess the acute oral toxicity of the test item in rats, the acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg a.i./kg bw (corresponding to 3640 mg/kg bw test item)as the starting dose in three female rats. No animal died in the first step at 2000 mg a.i./kg bw dose level, so treatment with 2000 mg a.i.kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. The animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on day 15 after the treatment. No mortality and no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of the experimental animals were normal. The body weight development was unaffected in all animals. All organs of the animals treated with 2000 mg a.i./kg bw proved to be free of treatment related gross pathological changes. The LD50 was found to be >2000 mg a.i./kg bw correspinding to >3640 mg test item/kg bw.
Inhalation:
The study does not need to be conducted as exposure of humans via inhalation is not the appropriate route of exposure. Furthermore, physicochemical and toxicological properties do not suggest a potential for a significant rate of respiratory absorption.
Dermal:
No study was conducted as the physiochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin.
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Based on available data on acute toxicity,
the test item is not classified according to Regulation (EC) No
1272/2008 (CLP), as amended f
or the twelfth time in Regulation (EU) No 2019/521.
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