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Diss Factsheets
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EC number: 296-120-8 | CAS number: 92257-31-3
- 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
One acute oral toxicity study of high reliability. one acute oral and one acute dermal toxicity study of low reliability.
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study methodology followed was equivalent or similar to OECD TG 401 and in accordance with the Principles of Good Laboratiory Practices (GLP).
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
-Source: Charles River Breeding Laboratories Inc., Wimington, Mass.
-Age at initiation: Young adult
-Identification Color coded cage tag
-Housing: Animals will be individually housed in wire mesh bottom cages when placed on study
-Food: NIH open formula 07, certified feed (Zeigler, Bro., Gardeners, PA), ad libitum. Food will be withheld the night prior to dosing.
-Water: Tap water, ad libitum.
-Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
-All environmental conditions controlled as per "Guide for the Care and Use of Laboratory Animals"
-Air Changes (per hour): 12-15 air changes/hour
-Photoperiod (hrs dark/hrs light): 12 hours light/dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Test Article Preparation Data
-Concentration Prepared: 50% w/v
-Diluent: Corn Oil
-Prepared Physical State: Slurry
Preperation Procedures:
-Weighted 20gm test article, Q.S. to 40ml with diluent (Corn oil) - Doses:
- Animals were fasted overnight (approximately 18 hours) prior to receiving a single oral dose of 5.0g/kg of the test article prepared as described previously. The test article was administered at a constant concentration.
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?): All animals were observed for at least 14 days or until all signs of reversible toxicity subsided wihichever occurred later. They were observed three times a day on the day of dosing and twice daily for the remainder of the study.
- Frequency of weighing: Body weights were recorded initially and on days 8 and 15 or at death.
- Necropsy of survivors performed: yes, All animals that died, and all survivors that were sacrificed at termination of the study were subjected to a gross necropsy. All abnormalities were recorded.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All gross or visible toxic or pharmacological effects were recorded. - Statistics:
- Mean initial, day 8 and day 15 body weights were calculated.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 0 - 27
- Mortality:
- No mortality was observed in any of the rats treated at the dose level of 5g Automate Red B Nonvolatile/kg body weight.
- Clinical signs:
- other: Decreased activity was observed in 5 males and 3 females. Soft stool was observed in 3 males. There were no other observations noted.
- Gross pathology:
- There were no noteworthy findings for males or females.
- Other findings:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of this study indicates that the LD50 is greater than 5.0g/kg of body weight in both male and female Sprague-Dawley rats.
- Executive summary:
The acute toxicity potential of of the test material was evaluated in both male and female Sprague Dawley rats, study methodology followed was equivalent to similar to OECD TG 401 and in accordance with the Principles of Good Laboratory practice (GLP) and under the conditions of the study, the LD50 in SD rats (combined sexes) was greater than 5.0 g/kg with 95% confidence limits ranging between 0 -27%.
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- acceptable for assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute Oral toxicity:
The acute toxicity potential of the test substance was evaluated in both male and female Sprague Dawley rats, study methodology followed was equivalent to similar to OECD TG 401 and in accordance with the Principles of Good Laboratory practice (GLP) and under the conditions of the study, the LD50 of the test substance in SD rats (combined sexes) was greater than 5.0 g/kg with 95% confidence limits ranging between 0 -27%.
Acute Dermal toxicity:
No reliable acute dermal toxicity studies are available for this substance. A study on a product containing the REACH substance as well as a solvent was performed at the Industrial Biotest laboratory prior to the introduction of GLP. Due to the concerns with data generated by that laboratory this study is consedered to be low reliability. However it does indicate that the substance has a low order of dermal toxicity and this is consistent with the acute oral toxicity data. Consequently it is justified to wiave the acute dermal toxicity study.
A summary of the acute dermal toxicity study is below:
The acute dermal toxicity potential of the test substance was evaluated in both male and female New Zealand White rabbits. 2 males and 2 females per dose group were dosed with either 6.8 or 10.2 g/kg of test material. There were no deaths in either dose groups. No untoward behavioral reactions were noted among any of the animals. Wrinkling of the skin at the application site was noted among animals in both groups by the seventh day of the l4-day observation period. By the end of the 14-day observation period escharosis was noted. The red color of the test material precluded evaluation of
the skin at the application site for erythema. No gross pathologic alterations were noted among any of the animals other than the dermal alterations previously described. The acute dermal LD50 of the test material in male and female New Zealand White Rabbits was determined to be > 10.2 g/kg
Justification for selection of acute toxicity – oral endpoint
Reliable study, equivalent to an OECD guideline study, conducted according to GLP
Justification for classification or non-classification
The Oral LD50 is greater than 2000 mg/kg bw and the available dermal toxicity data do not indicate any acute toxicity via this route. Based on these data this substance does not meet the criteria for classification for acute toxicity.
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.
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