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EC number: 268-871-1 | CAS number: 68153-22-0
- 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
In a GLP compliant, dermal irritation, study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from 24, 48 and 72 hours, was scored according to the Draize (1977) scale as follows: erythema 0.33 and edema 0.11, all observed signs of irritation completely reversed within 48 hours. Under the conditions of the test, the observed dermal reaction was not severe enough to justify a classification according to Regulation (EC) 1272/2008
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13 - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Av. of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Av. of 24, 48 and 72 hour
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Other effects:
- - No abnormal physical signs were noted during the observation period.
- One animal lost body weight, all other weight changes were normal. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study concludes that the test material is a dermal irritant. However under the conditions of the test to severity of the dermal reaction observed was not enough to justify a classification according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified".
- Executive summary:
In a GLP compliant, dermal irritation, study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from 24, 48 and 72 hours, was scored according to the Draize (1977) scale as follows: erythema 0.33 and edema 0.11, all observed signs of irritation completely reversed within 48 hours. Under the conditions of the test, the observed dermal reaction was not severe enough to justify a classification according to Regulation (EC) 1272/2008.
Reference
Table 2. Results of Observed Dermal Reactions
Observation | Animal and Sex | Time after patch removal | Average Score of 24, 48 and 72 hrs. | ||||
60 (mins) | 24 (hrs) | 48 (hrs) | 72 (hrs) | ||||
Erythema Score | Female No. 1 | 2 | 1 | 0 | 0 | 0.33 | |
Female No. 2 | 1 | 1 | 0 | 0 | |||
Male No. 3 | 1 | 1 | 0 | 0 | |||
Edema Score | Female No. 1 | 0 | 0 | 0 | 0 | 0.11 | |
Female No. 2 | 0 | 0 | 0 | 0 | |||
Male No. 3 | 1 | 1 | 0 | 0 |
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13 - Reason / purpose for cross-reference:
- read-across source
- Controls:
- other: The contralateral eye served as a control.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No reaction observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No reaction observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No reaction observed
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared within 72 hours.
- Other effects:
- - No abnormal physical signs were noted during the observation period.
- Interpretation of results:
- not irritating
- Conclusions:
- Under the conditions of the test, the test material was determined to be non-irritating according to Regulation (EC) 1272/2008. The material tested in this study has a TAN range of 24-40. The observed ocular effects in the three animals were not severe enough to warrant classification. Initially animals displayed mild chemosis and discharge which completely cleared by 24 hours. Two of the three animals showed mild conjunctiva redness which was completely reversible within 72 hours.
- Executive summary:
In a GLP compliant study performed according to the standardised guideline EPA OPPTS 870.2440, the ocular irritation caused by exposure to the test material was assessed in three rabbits. They were exposed to 0.1 ml of the test material using their contralateral eye as a control. Initially some mild irritation (chemosis and discharge) was observed, however this did not persist past 1 hour. Conjunctiva redness was the parameter which persisted past 1 hour and was assigned an average score of 0.33 according to the Draize scale (1977), this was completely reversible within 72 hours. Under the conditions of this study the test material (which has a TAN range of 24 - 40) does not require classification as an eye irritant in line with Regulation (EC) 1272/2008.
Reference
Table 2. Results for Ocular Damage.
Animal No. | Tissue | Reading | 1 hr | 24 hrs | 48 hrs | 72 hrs | Mean Score from 24, 48 and 72 hours |
1 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 |
Area | 0 | 0 | 0 | 0 | |||
SubTotal | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | ||
SubTotal | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 2 | 0 | 0 | 0 | 0 | |
Chemosis | 2 | 0 | 0 | 0 | 0 | ||
Discharge | 2 | 0 | 0 | 0 | |||
SubTotal | 12 | 0 | 0 | 0 | |||
Total | 12 | 0 | 0 | 0 | |||
2 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 |
Area | 0 | 0 | 0 | 0 | |||
SubTotal | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | ||
SubTotal | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 2 | 1 | 0 | 0 | 0.33 | |
Chemosis | 2 | 0 | 0 | 0 | 0 | ||
Discharge | 2 | 0 | 0 | 0 | |||
SubTotal | 12 | 2 | 0 | 0 | |||
Total | 12 | 2 | 0 | 0 | |||
3 | Cornea | Opacity | 0 | 0 | 0 | 0 | 0 |
Area | 0 | 0 | 0 | 0 | |||
SubTotal | 0 | 0 | 0 | 0 | |||
Iris | 0 | 0 | 0 | 0 | 0 | ||
SubTotal | 0 | 0 | 0 | 0 | |||
Conjunctiva | Redness | 2 | 1 | 1 | 0 | 0.66 | |
Chemosis | 2 | 0 | 0 | 0 | 0 | ||
Discharge | 2 | 0 | 0 | 0 | |||
SubTotal | 12 | 2 | 2 | 0 | |||
Total | 12 | 2 | 2 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Classification criteria not met.
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