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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-781-7 | CAS number: 38103-06-9
- 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
A skin irritation study conducted on rabbits performed according to US EPA TSCA Health Effects Test Guidelines elicited no dermal irritation.
EYE
An eye irritation study conducted on rabbits performed according to US EPA TSCA Health Effects Test Guidelines indicated that the material is not irritating.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Male and female New Zealand White rabbits, approximately 12 to 18 weeks of age, weighing 2.0 to 3.0 kg were obtained from Hazleton-Dutchland, Inc. The animals were acclimated for at least five days and individually housed in cages with wire floors. They were maintained on rabbit diet and provided water (municipal) ad libitum. Room temperature ranged from 67 °F to 70 °F and the relative humidity ranged between 48-56%. Room lights were on a 12-hour cycle.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Six rabbits were dosed with 0.5 g of test material moistened with distilled water on the shaved dorsal area of the trunk. A one-inch square gauze patch was placed over the dose site and secured with adhesive tape. Plastic sheeting was secured loosely around the trunk of each animal.
- Duration of treatment / exposure:
- The exposure time was four hours.
- Observation period:
- Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema/edema was observed for any animal at any time period.
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the test material is considered to be a non-irritant.
- Executive summary:
The skin irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).
Six New Zealand White rabbits were dosed with the test material in a semi-occlusive fashion for four hours. Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.
No erythema/oedema was observed for any animal at any time period.
Under the conditions of this study, the test material is considered to be a non-irritant.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male and female New Zealand White rabbits, approximately 12 to 18 weeks of age, weighing 2.0 to 3.0 kg were obtained from Hazleton-Dutchland, Inc. The animals were acclimated for at least five days and individually housed in cages with wire floors. They were maintained on rabbit diet and provided water (municipal) ad libitum. Room temperature ranged from 67 °F to 70 °F and the relative humidity ranged between 48-56%. Room lights were on a 12-hour cycle.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Six rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. The test material was placed in the conjunctival sac of the eye and the lids were held together for one second. One eye was dosed, per rabbit, with test material, while the other eye served as a control.
- Observation period (in vivo):
- Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose. Fluorescein staining was included at one day and subsequent days.
- Number of animals or in vitro replicates:
- Six
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Treatment with BPA-DA resulted in no corneal injury in any of the 6 rabbit eyes. Two rabbits developed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.
- Other effects:
- One animal was found dead on Day 6, this was not considered to be treatment-related.
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the test material caused minor ocular irritancy overall and requires no classification in accordance with EU criteria.
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).
Six New Zealand White rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose.
Treatment resulted in no corneal injury in any of the 6 rabbit eyes. At the 1 hour observation two rabbits displayed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.
Under the conditions of this study, the test material is considered to be a non-irritant.
Reference
Rabbit No. |
87-33761 |
87-33762 |
87-33763 |
87-33780 |
87-33781 |
87-33782 |
Mean |
|
Score/Effects at 1 Hour |
||||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
1 |
0 |
0 |
1 |
0 |
0.3 |
Conjunct: |
Redness |
1 |
1 |
1 |
1 |
1 |
1 |
1.0 |
Chemosis |
1 |
1 |
1 |
1 |
1 |
0 |
0.8 |
|
Discharge |
3 |
2 |
2 |
1 |
1 |
1 |
1.7 |
|
Score/Effects at 24 Hours |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Score/Effects at 48 Hours |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Score/Effects at 72 Hours |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Score/Effects at 7 Days |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Other Effects: Rabbit 33780 found dead on Day 6 from unknown causes (probably not dose-related). |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988). The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Six New Zealand White rabbits were dosed with the test material in a semi-occlusive fashion for four hours. Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.
No erythema/oedema was observed for any animal at any time period.
Under the conditions of this study, the test material is considered to be a non-irritant.
Eye
The eye irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Six New Zealand White rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose.
Treatment resulted in no corneal injury in any of the 6 rabbit eyes. At the 1 hour observation two rabbits displayed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.
Under the conditions of this study, the test material is considered to be a non-irritant.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin or eye irritation.
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.