Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 248-502-0 | CAS number: 27503-81-7
- 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 substance is neiter classifiable for acute oral toxicity nor for acute dermal toxicity. An inhalative study is not available and not required considering the low vapour pressure of the substance and its use in cosmetic skin formulations.
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:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- study was performed prior to OECD guideline availability but followed in principle the method as described there. The toxicity of the test material after oral administration was studies in Wistar rats. A 16.5% solution of the test item was administered orally (gavage) to 10 animals at a volume of 40 mL/kg body weight (bw) resulting in a dose of 6600 mg/kg. After an observation period of 14 days the animals were killed and investigated for macroscopic signs of pathological changes.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- other: mouse and rat
- Strain:
- other: mouse--CF-1; rat--Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Experimental animals and housing conditions
Animals employed in this study were male SPF-bred mice of the strain CF1 with a mean weight of about 20 g and male SPF-bred Wistar rats with a mean weight of 220 g.
The mice had been supplied by Winkelmann - Kirchborchen, the rats by Mus Rattus AG, Brunnthal near Munich. Mice and rats were housed in groups of 5 animals each in Makrolon Type I and Type III cages, respectively, at a room temperature of about 22 °C and natural light.They received pellets of dry feed (supplier, Altromin GmbH, Lage/Lippe) and water ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Test article-Na solution was administered in its present form as a 16.5% concentration with an application volume of 40 ml/kg body weight, which is, for technical reasons, the maximum volume to be applied. Administration to mice and rats was performed using a gavage. Prior to application the animals were kept non-fasted.
- Doses:
- 6600 mg were administered as a 16,5% Novantisol-Na solution at a volume of 40 ml/kg body weight.
- No. of animals per sex per dose:
- 10 mice; 10 rats
- Control animals:
- not specified
- Details on study design:
- Signs and deaths occurring during a 14-day observation period were recorded in the study records. After the observation period the animals were sacrificed and necropsied.
- Statistics:
- Calculation of the LD50 on the confidence level of p=0.5 is usually performed with the program-controlled probit analysis according to FINK and HUND.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 6 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 6,600 mg test article-Na was tolerated by the animals investigated without signs.
- Mortality:
- No mortality was observed throughout the observation period (14 days).
- Clinical signs:
- other: Acute toxicity of test article-Na in mice after oral administration: 6,600 mg test article-Na was tolerated by the mice investigated without signs. As the 6,600 mg were administered as a 16.5 % Test article-Na solution at a volume of 40 ml/kg body weight
- Gross pathology:
- Necropsy of the mice sacrificed after a 14-day observation period gave no indication of macroscopically noticeable pathological changes.
Neither did necropsies of rats after 14 days of observation give any indication of pathological organ changes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (oral, rat/mouse): >6600 mg/kg body weight
- Executive summary:
This acute toxicity of test article was performed with mice and rats at a single concentration of 6600 mg/kg body weight by oral gavage. As the 6,600 mg were administered as a 16.5 % Test article-Na solution at a volume of 40 ml/kg body weight and administration of a higher dose was not possible for technical reasons, no lethal dose could be established. Necropsy of the animals sacrificed after a 14-day observation period gave no indication of macroscopically noticeable pathological changes.
In conclusion, LD50 of sodium salt of test article is considered to be greater than 6600 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 600 mg/kg bw
- Quality of whole database:
- Besides the key study performed with sodium salt of test substance also two supportive studies are available, one performed with the sodium salt of test substance (LD50 >16000 mg/kg bw) and one with the substance itself (LD50 >5000 mg/kg bw). Thus, there is a solid basis for considering this substance practically non toxic.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- occlusive patch was used
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: EMD SPF
- Weight at study initiation: 148 (121 - 176) g
- Housing: separately in Macrolon Type III cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 26 °C
- Humidity (%): 42 - 47 %
IN-LIFE DATES: From: day 1 To: day 14 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10
- Type of wrap if used: tin foil fixed and sealed with rubber sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL / 100 g bw
- Concentration (if solution): 30 % in water
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 3000 mg/kg bw
- No. of animals per sex per dose:
- 10 (5m, 5f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 2 weeks
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- no statistics
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed. All animals survived the observation period (14 days).
- Clinical signs:
- other: On the day of treatment the mobility and well-being of the rats were necessarily limited by the rubber sleeve applied. After 24 hours all rats were free from symptoms. No local effects were observed at the treated skin sites.
- Gross pathology:
- No pathologicol-anatomical changes were observed in any of the rats.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the dermal LD50 of Phenylbenzimidazole sulfonic acid (Na-salt) in rats is > 3.000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the test material was investigated in Wistar-AF rats.
A 30 % aqueous solution of the test item corresponding to a dose of 3000 mg/kg bw was applied on the shaved skin of 5 male and 5 female rats for 24 hours under occlusive conditions (tin foil fixed and sealed with rubber sleeve). After 24 hours the tin foil was removed and residual test item was washed off with water. The rats were observed and weighed daily for 14 days.
Changes at the application site were rated according to Draize (FDA Appraisal, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics by FDA, Baltimore Md. 1959, page 51).
No mortalities were observed during the observation period of 14 days. No local effects were observed at the treated skin sites. At necropsy no pathological changes were observed in any of the rats.
Based on the results of this study the dermal LD50 of Phenylbenzimidazole sulfonic acid (Na-salt) in rats is > 3.000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
- Quality of whole database:
- Two studies are available providing very consistent results, although neutralized with different alkali.
Additional information
Oral
Besides the key study performed with sodium salt of test substance (LD50 >6600 mg/kg bw) also two supportive studies are available, one performed with the sodium salt of test substance (LD50 >16000 mg/kg bw) and one with the substance itself (LD50 >5000 mg/kg bw). Thus, there is a solid basis for considering this substance practically non toxic.
Dermal
Two studies are available for acute dermal toxicity, one applying a 30 % solution of sodium hydroxide neutralized test substance and one using triethanolamine neutralized test substance in aqueous solution to the back skin of rats. In both tests 3000 mg/kg bw were dermally applied and the LD50 (dermal rat) was established at >3000 mg/kg in both. Thus, in a weight of evidence approach the substance is considered not classifiable for acute dermal toxicity.
Inhalative
An inhalative study is not available and not
required considering the low vapour pressure, the particle size
distribution of the substance and its use in cosmetic skin formulations.
Justification for classification or non-classification
Based on the acute oral toxicity results (LD50 >6600 mg/kg bw) and the acute dermal toxicity results (LD50 >3000 mg/kg bw) the substance does not require classification according to CLP (Regulation EC No 1272/2008).
As the substance is solid and not of hydrocarbon nature, aspiration hazard classification is not appropriate.
According to regulation (EC) 1907/2006 Annex XI (weight of evidence), testing for acute inhalation toxicity is not considered to be required, for the following reasons:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid has a negligible vapour pressure. Thus an acute 4-hour inhalation study would be carried out at the limit dose of 5 mg/L aerosol. Assuming a very conservative value of 100 % bioavailability, a rat would receive a systemic dose of 0.8 L/min/kg x 240 min x 5 mg/L aerosol = 960 mg/kg.
- Since the acute oral LD50 was higher than this value, it is considered unlikely that mortality would be observed in an acute inhalation study.
- With regard to possible local respiratory effects, 2-phenyl-1H-benzimidazole-5-sulphonic acid is not classified for skin or eye irritation and showed no irritation effects on skin or on the mucosal membranes of the eyes. Therefore, 2-phenyl-1H-benzimidazole-5-sulphonic acid is considered unlikely to exert a relevant local irritative effect on respiratory mucosal membranes.
Therefore, performance of an acute inhalation study is considered not necessary for scientific reasons and 2-phenyl-1H-benzimidazole-5-sulphonic acid is considered unlikely to exert effects upon inhalation that would require classification according to CLP (Regulation (EC) No. 1272/2008.
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.