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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 not irritating to skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 10 - 17, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 38 to 41 weeks
- Weight at study initiation: 4,05 (3,30 - 4,56) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm^2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20 °C
- Humidity (%): 53 to 89 %
IN-LIFE DATES: From: day 1 To: day 8 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of undiluted or diluted (16 % aqueous solution) test item was applied
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 6 (3m, 3f)
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm2
- % coverage: 100 %
- Type of wrap if used: polyethylene foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 5 days
- Remarks on result:
- other: with undiluted test item
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: with undiluted test item
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: with diluted test item
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: with diluted test item
- Other effects:
- No signs of systemic toxicity were detected. The body weight development was not different from that of untreated rabbits of the same age. All animals survived the 8-day observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test material is evaluated as not irritating to the skin.
- Executive summary:
The test material was tested for primary skin irritation in New Zealand White rabbits (Iva: NZW) in a GLP Study according to test guideline OECD 404. The test item was tested undiluted and as a 16 % aqueous solution. Six animals (3 males and 3 females) were used for this study. Aliquots of 0.5 mL of either the undiluted or diluted test item were given onto 4 cm2 patches and applied onto the left side of the shaved backs of each animal. The diluted test item was applied to the right side of each animal. The patches were wrapped by polyethylene foil under occlusive conditions. After 4 hours of occlusive exposure the patches were removed and any test item left was wiped off. The animals were investigated for skin alterations, clinivcal symptoms and body weight for a period of 8 days. Skin changes at the application sites were evaluated according to Draize (1959). The application of the undiluted test item to the intact dorsal skin of rabbits for 4 hours under occlusive conditions resulted in very slight skin irritation: The 24/48/72 hours values for erythema in the 6 animals were 0.0 in 5 animals and 1.0 in one animal (mean 0.17). The effects observed in the one animal were reversible and vanished on day 5. The 24/48/72 hours mean value for edema were 0.0 in all animals. Treatment with the 16 % aqueous solution of the test item did not result in any effect, i.e. the 24/48/72 mean values for erythema and edema in all 6 animals were 0.0. Based on the results of this study, the test material is evaluated as not irritating to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 18 to May 25, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.69 (:,43 - 2.91) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm^2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24 °C
- Humidity (%): 44 to 67 % - Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml Test item liquid (containing 40 % Eusolex 232 in water)
- Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3 (2m, 1f)
- Details on study design:
- To ensure that only rabbits without ocular abnormalities were included in the study, 24 hours before treatment ophthalmological examinations were performed after instillation of 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope after Eisenhut (Basel).
SCORING SYSTEM: DRAIZE, J.H.: "Dermal toxicity", In.: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Association of Food and Drug Officials of the USA (eds.), Baltimore (1959)
TOOL USED TO ASSESS SCORE: ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 and CLP.
- Executive summary:
The primary eye irritation potential of Phenylbenzimidazole sulfonic acid was tested in 3 New Zealand White rabbits according to test guideline OECD 405. Aliquots of 0.1 mL of a liquid formulation consisting of 40 % active substance was instilled into the conjunctival sac of the left eye of each of 3 rabbits. The right eyes remained untreated and served as controls. The rabbits were investigated for eye irritation 1 hour after treatment and then daily for a period of 8 days. Effects on the cornea, iris and conjunctivae were evaluated according to the Draize scale (1959). After single instillation of 0.1 mL of a formulation consisting of 40 % Phenylbenzimidazole sulfonic acid into the conjunctival sac of the left eye, without rinsing, a very slight irritation (slight reddening) of the conjunctivae was observed in one rabbit only on day 1 of the study. Afterwards no irritation could be detected. No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 and CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance was tested for skin and eye irritation/corrosion by applying the neutralized form (with triethanolamine or sodium hydroxide) to skin respectively eyes of rabbits in concentrations of 72 % and 10 % respectively. In none of the studies eye or skin irritation was observed.
Justification for classification or non-classification
In both in vivo tests on skin irritation and in an in vivo test on eye irritation no effects were observed on skin and eyes and thus the substance is not considered for skin or eye irritation/corrosion classification according to CLP (Regulation EC No 1272/2008).
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