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EC number: 205-055-6 | CAS number: 132-27-4
- 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
Skin irritation / corrosion (OECD 404): corrosive
Eye irritation / corrosion (OECD 405): serious eye damage
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:
- 08 - 15 Mar 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd. (breeder)
- Weight at study initiation: 3.1, 3.2 and 3.3 kg, respectively
- Housing: The rabbits were individually housed in single cages (wire cages type III-high). Below the cages excrement trays with low-dust wood granulate type S 8/15 (Ssniff, Soest, Germany) were located.
- Diet: Standard diet "Ssniff K 4" (supplied by Versuchstierdiäten GmbH, Soest, Germany), approximately 100 - 120 g per animal and day
- Water: Tap water, ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): Approximately 50
- Air changes (per hr): Approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08 Mar 1988 To: 15 Mar 1988 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: The test substance was made into a paste with water. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm² on the dorsal area of the trunk
- Type of wrap: The treated skin was covered with Hansamed plaster and fixed with an elastic adhesive bandage (Fixomull-Strech adhesive non-woven material, Beiersdorf No. 1524).
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritant / corrosive response data:
- All 3 animals showed edema and erythema scores of 3 at the 1-h reading time point, which resulted in an edema and erythema score of 4 at the 24-, 48- and 72-h and at the 7-day reading time point. In addition, the skin of all 3 rabbits displayed necrotic changes after 24 h.
- Interpretation of results:
- other: Skin Corr 1A, H314 according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: Skin Corr 1A, H314
Reference
Table 1: Summary of results
Observation time | Rabbit no. | |||||
1 | 2 | 3 | ||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | |
1 h | 3 | 3 | 3 | 3 | 3 | 3 |
24 h | 4 | 4 | 4 | 4 | 4 | 4 |
48 h | 4 | 4 | 4 | 4 | 4 | 4 |
72 h | 4 | 4 | 4 | 4 | 4 | 4 |
Mean value 24 + 48 + 72 h | 4,00 | 4,00 | 4,00 | 4,00 | 4,00 | 4,00 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd. (breeder)
- Weight at study initiation: 3.0, 3.1 and 3.6 kg, respectively
- Housing: The rabbits were individually housed in single cages (wire cages type III-high). Below the cages excrement trays with low-dust wood granulate type S 8/15 (Ssniff, Soest, Germany) were located.
- Diet: Standard diet "Ssniff K 4" (supplied by Versuchstierdiäten GmbH, Soest, Germany), approximately 100 - 120 g per animal and day
- Water: Tap water, ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): Approximately 50
- Air changes (per hr): Approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08 Mar 1988 To: 15 Mar 1988 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with pysiological sodium chloride solution.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 1% fluorescein solution and ultraviolet light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritant / corrosive response data:
- Animal #1 and #2 showed a cornea opacity score of 2 at the 1-, 24-, 48- and 72-h reading time point, which increased at the 7-day reading time point (score of 3). Animal #3 showed a cornea opacity score of 1 at all reading time points. The iris score was 1 and the conjunctivae score was 2 for all 3 rabbits at all reading time points. A slight swelling (chemosis score of 1) was determined in rabbit #1 at the 1-h and 7-day reading time point, which enhanced to a distinct swelling (score of 2) at the 24-, 48- and 72-h reading time point. A slight swelling was also observed at the 1-h reading time point in rabbit #2, which resulted in a distinct swelling (score of 2) at the 24- and 48-h reading time point in a score of 3 at the 72-h reading time point. This effect was not reversible within 7 days (score 2). Rabbit #3 showed a chemosis score of 1 at all reading time points.
The mucous membrane of the third eyelid of the animals was necrotized from the first evaluation. At the 7-day reading time point, 1/3 rabbits had a corneal pannus and hair loss at the upper and lower margin of the eyelid, respectively. - Interpretation of results:
- other: Eye Dam. 1, H318 according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
Reference
Table 1: Summary of Results
Rabbit # | Time [h] | conjunctivae | iris | cornea | |
redness | swelling | ||||
1 | 1 | 2 | 1 | 1 | 2 |
24 | 2 | 2 | 1 | 2 | |
48 | 2 | 2 | 1 | 2 | |
72 | 2 | 2 | 1 | 2 | |
average | 2,0 | 2,0 | 1,0 | 2,0 | |
2 | 1 | 2 | 1 | 1 | 2 |
24 | 2 | 2 | 1 | 2 | |
48 | 2 | 2 | 1 | 2 | |
72 | 2 | 3 | 1 | 2 | |
average | 2,0 | 2,3 | 1,0 | 2,0 | |
3 | 1 | 2 | 1 | 1 | 1 |
24 | 2 | 1 | 1 | 1 | |
48 | 2 | 1 | 1 | 1 | |
72 | 2 | 1 | 1 | 1 | |
average | 2,0 | 1,0 | 1,0 | 1,0 | |
Time [h] | conjunctivae | iris | cornea | ||
redness | swelling | ||||
average score |
1 | 2,00 | 1,00 | 1,00 | 1,67 |
24 | 2,00 | 1,67 | 1,00 | 1,67 | |
48 | 2,00 | 1,67 | 1,00 | 1,67 | |
72 | 2,00 | 2,00 | 1,00 | 1,67 | |
24+48+72 | 2,00 | 1,78 | 1,00 | 1,67 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are in vivo data available regarding skin and eye irritation / corrosion for sodium 2-biphenylate (CAS 132-27-4) in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.1 and 8.2.
Skin
The skin irritation potential of the registered substance was examined in an in vivo skin irritation test with 3 male NZW rabbits performed according to OECD Guideline 404 and in compliance with GLP (Bayer AG, 1988). A dose of 0.5 g of the test substance was applied on the dorsal area of the trunk under semiocclusive conditions for 4 h. Thereafter the test substance was removed with water. Skin reactions were assessed 1, 24, 48 and 72 hours, and 7 days after exposure according to the Draize scoring system. All 3 animals showed edema and erythema scores of 3 at the 1-h reading time point, which respectively increased up to 4 at the 24-, 48- and 72-h and at the 7-day reading time point. In addition, the skin of all 3 rabbits displayed necrotic changes after 24 h. Based on these results the test substance is considered to be corrosive.
A non-GLP conform in vivo skin irritation test according to Draize with the test substance was used as supporting information (Bayer AG, 1983). In this study, 0.5 g of the test substance was applied on the inner surface of one ear each of 2 NZW rabbits for 24 h under occlusive dressings. The untreated ear served as control. Skin reactions were assessed 24 and 72 hours, and 7 days after exposure according to Draize scoring system. Reddening of the skin was observed at the 24-h and 72-h reading time point in both animals with a score of 4, which persisted up to the end of the observation period of 7 days. Swelling of the skin with a score of 3 was determined in both rabbits at the 24-h and 72-h reading time point, which slightly decreased to a score of 2 at the end of the observation period. Based on these results the test substance is considered to be corrosive.
Information on skin irritation was available from a further study (Bayer AG, 1978). Due to methodical limitations, e. g. individual scores at different reading time points were not given, the study was taken into account for the evaluation but not included as separate record. In this study, the inner surface of one ear each of 2 NZW rabbits was treated with 500 mg test substance for 24 h. The test substance was removed with water and soap/vegetable oil and thereafter the animals were observed for 7 days. The test substance was reported to be highly irritant.
Overall, sodium 2-biphenylate (CAS 132-27-4) is considered to exhibit corrosive properties towards the skin.
Eye
The eye irritation/corrosion potential of the registered substance was examined in an in vivo eye irritation test in 3 male NZW rabbits according to OECD Guideline 405 and in compliance with GLP (Bayer AG, 1988). An amount of 0.1 mL of the test substance was instilled into the conjunctival sac of each rabbit, the untreated eye served as control. Observations were made 1, 24, 48 and 72 h, and 7 days after instillation according to Draize scoring system. 2/3 animals showed a cornea opacity score of 2 at the 1-, 24-, 48- and 72-h reading time point, which increased at the 7-day reading time point (score of 3). The other animal showed a cornea opacity score of 1 at all reading time points. The iris score was 1 and the conjunctivae score was 2 for all 3 rabbits at all reading time points. A slight swelling (chemosis score of 1) was determined in rabbit #1 at the 1-h and 7-day reading time point, which enhanced to a distinct swelling (score of 2) at the 24-, 48- and 72-h reading time point. A slight swelling was also observed at the 1-h reading time point in rabbit #2, which resulted in a distinct swelling (score of 2) at the 24- and 48-h reading time point in a score of 3 at the 72-h reading time point. This effect was not reversible within 7 days (score 2). Rabbit #3 showed a chemosis score of 1 at all reading time points. Moreover, the mucous membrane of the third eyelid of the animals was necrotized from the first evaluation. At the 7-day reading time point, 1/3 rabbits had a corneal pannus and hair loss at the upper and lower margin of the eyelid, respectively. Based on these results, the test substance is considered to result in severe eye damage.
A non-GLP in vivo eye irritation test performed in 2 NZW rabbits and according to Draize was used as supporting information (Bayer AG, 1983). In this study, 0.1 g of the test substance was instilled into the conjunctival sac of each rabbit for 4 h. Observations were made 1, 24, 48 and 72 hours, and 7 days after instillation. In animal #1 a cornea opacity score and an iris score of 1 was noted at all reading time points, only the effects on the iris were fully reversible at the 7-day reading time point. In animal #2 opacity of the cornea and effects on the iris were observed at the 1-h reading time point (score 1), which increased to a score of 2 at the 24-, 48-, 72-h reading time point. Both effects were not fully reversible up to the end of the observation period. Redness (scores 3) and swelling (score 2) were noted in both animals at the 1-, 24-, 48-, 72-h reading time point without being fully reversible at the 7-day reading time point. Based on these results, the test substance is considered to result in severe eye damage.
Information on eye irritation was available and taken into account from a further study (Bayer AG, 1978). Due to methodical limitations, the study was taken into account for the evaluation but not included as separate record. In this study, 50 mg test substance was instilled into the conjunctival sac each of 2 NZW rabbits. The animals were observed for 7 days (not further details given). The test substance was reported to be highly irritant and corrosive.
Overall, sodium 2-biphenylate (CAS 132-27-4) causes severe damages to the eye due to its corrosive properties.
Justification for classification or non-classification
The available data on skin and eye irritation / corrosion meet the criteria for classification according to Regulation (EC) No. 1272/2008, and therefore sodium 2-biphenylate (CAS 132-27-4) is classified as Skin Corr. 1, H314 and Eye Dam. 1, H318.
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