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EC number: 293-878-1 | CAS number: 91648-19-0
- 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
Studies of skin and eye irritation in vivo are available for the substance.
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:
- 25 May 1995 to 27 July 1995
- 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
- Specific details on test material used for the study:
- Betadet SHR
Lot number: 7049
pH 7.48
Appearance: viscous yellowish liquid
Storage: Room temperature protected from light - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Accredited supplier
Weight on receipt: 2.0-2.1 kg
Age on receipt: 9-10 weeks
Acclimatisation period: 7 days
Weight on dosing: 2.3-2.4 kg
Housing: Individually in stainless steel cages with grille floor
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour light/dark cycle
Food: Standard rabbit diet UAR 112, ad libitum
Water: Compañia de Aguas de Sabadell, S. A., ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of test substance
- Duration of treatment / exposure:
- Four hours and then removed by washing
- Observation period:
- 30-60 minutes and 24, 48 and 72 hours after the end of the exposure period.
- Number of animals:
- Three
- Details on study design:
- The animals were shaved approximately 24 hours before test substance administration using a razor leaving the back and sides from the scapula to the pelvis exposed. One square test zone of 6 cm2 was delimited on the shaved intact skin of one side of the animals. The test substance was applied in a single dose of 0.5 mL. The substance was placed on a 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. The animals were observed for a few moments and returned back to their cages. After 4 hours, the bandage and patches were removed and the remainder of the product eliminated with water.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in all animals approximately 60 minutes following removal of the patch; this persisted to 48 hours in one rabbit. No oedema was observed in any rabbit.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Betadet SHR was found to cause minimal transient skin irritation in this study and does not require classification as a skin irritant under CLP.
- Executive summary:
A skin irritation study was conducted with Betadet SHR according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. Very slight erythema (grade 1) was observed in all animals approximately 60 minutes following removal of the patch; this persisted to 48 hours in one rabbit. No oedema was observed in any rabbit. Betadet SHR was found to cause minimal transient skin irritation in this study and does not require classification as a skin irritant under CLP.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Irritation scores
|
60 minutes |
24 hours |
48 hours |
72 hours |
Mean (24-72 hours) |
Erythema |
1,1,1 |
0,0,1 |
0,0,1 |
0,0,0 |
0.22 |
Oedema |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
0.00 |
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:
- 25 May 1995 to 28 July 1995
- 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
- Specific details on test material used for the study:
- Betadet SHR
Lot number: 7049
pH 7.48
Appearance: viscous yellowish liquid
Storage: Room temperature protected from light - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand White male rabbits were used.
Weight on receipt: 2.0-2.2 kg
Age on receipt: approximately 9-10 weeks
Source: B and K Universal G.J., S.L.
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: seven days
Weight at administration of test substance: 2.2-2.4 kg
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days after treatment
- Duration of post- treatment incubation (in vitro):
- .
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Following administration of the test substance, the eyelids were held closed for approximately 10 seconds. The behaviour of the animals was observed following instillation of the test substance. The animals were then returned to their cages.
The degree of eye irritation as evaluated for each rabbit at 1, 24, 48 and 72 hours after treatment. Additional observations were made on Days 7, 14 and 21 after treatment to check the reversibility of the reactions.
Observations were made after applying 2% aqueous sodium fluorescein to test the area and washing with physiological saline, with the exception of the 1 hour observations. Corneal alterations were made with the aid of a transilluminator with a cobalt blue filter. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks:
- Reversible in two rabbits; findings persisted (grade 1) to 21 days in one rabbit
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Instillation of the submission substance into the eyes of three rabbits caused marked eye irritation (corneal opacity, iridial infllammation, conjunctival erythema and chemosis). Irritation was reversible in two rabbits but persisted (grade 1 conjunctival chemosis only) in one rabbit at 21 days.
- Executive summary:
The submission substance Betadet SHR was instilled (0.1 mL) into one eye of three New Zealand White rabbits in accordance with OECD TG 405. Ocular irritation was scored for up to 21 days after instillation, using the Draize scale. Signs of irritation included corneal opacity (Grade 1 in all animals, fully reversible by 21 days); iridial inflammation (Grade 1 in all animals, fully reversible by 14 days); conjunctival erythema (Grade 3 in all animals, fully reversible by Day 21); and conjunctival chemosis (Grade 2-3). Grade 1 conjunctival chemosis persisted in one rabbit at 21 days. The mean scores for corneal opacity (mean score ≥1), iridial inflammation (mean score ≥1) and conjunctival erythema (mean score ≥2) result in classification of the substance as a Category 2 eye irritant according to the CLP Regulation; however the lack of complete reversibility of conjunctival chemosis in one rabbit at 21 days triggers classification in Category 1.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Eye irritation scores
|
60 minutes |
24 hours |
48 hours |
72 hours |
Mean (24-72 hours) |
7 days |
14 days |
21 days |
Cornea |
0,0,0 |
1,1,1 |
1,1,1 |
1,1,1 |
1.00 |
1,0,0 |
1,0,0 |
0,0,0 |
Iris |
1,1,1 |
1,1,1 |
1,1,1 |
1,1,1 |
1.00 |
1,1,0 |
0,0,0 |
0,0,0 |
Erythema |
3,2,2 |
3,3,3 |
3,3,3 |
2,3,2 |
2.78 |
1,2,1 |
0,1,1 |
0,0,0 |
Chemosis |
2,3,2 |
2,3,2 |
1,2,2 |
1,2,2 |
1.89 |
1,1,1 |
1,0,1 |
0,0,1 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A skin irritation study was conducted with the substance Betadet SHR according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. Very slight erythema (grade 1) was observed in all animals approximately 60 minutes following removal of the patch; this persisted to 48 hours in one rabbit. No oedema was observed in any rabbit. Betadet SHR was found to cause minimal transient skin irritation in this study and does not require classification as a skin irritant under CLP.
Eye irritation
The substance Betadet SHR was instilled (0.1 mL) into one eye of three New Zealand White rabbits in accordance with OECD TG 405. Ocular irritation was scored for up to 21 days after instillation, using the Draize scale. Signs of irritation included corneal opacity (Grade 1 in all animals, fully reversible by 21 days); iridial inflammation (Grade 1 in all animals, fully reversible by 14 days); conjunctival erythema (Grade 3 in all animals, fully reversible by Day 21); and conjunctival chemosis (Grade 2-3). Grade 1 conjunctival chemosis persisted in one rabbit at 21 days. The mean scores for corneal opacity (mean score ≥1), iridial inflammation (mean score ≥1) and conjunctival erythema (mean score ≥2) result in classification of the substance as a Category 2 eye irritant according to the CLP Regulation; however the lack of complete reversibility of conjunctival chemosis in one rabbit at 21 days triggers classification in Category 1.
Justification for classification or non-classification
Based on the results of the skin irritation study, classification is not required. Based on the results of the eye irritation study, classification for eye irritation in Category 1 is required.
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