Registration Dossier
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: 248-778-2 | CAS number: 28016-00-4
- 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
Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant to the rabbit's skin.
Six rabbits were exposed to the test material for 4 hours. No full destruction of the skin was observed. Therefore it can be concluded that the test material is not corrosive.
Eye irritation
The test substance was installed in the eye of 6 rabbits. During the 14 day observation period severe eye irritation is observed. The test substance is considered to be an eye irritant category 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- limited report, non-GLP, test with formulation. limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA, CFR Title 21, para. 191.11
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Bodyweight: 2.3 to 3.0 kg
No further details - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% in diluent oil - Duration of treatment / exposure:
- 24 hours
- Observation period:
- scored 24 and 72 hours after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- Abrasions made over 2-3 cm2
- Type of wrap if used: plastic trunk band to prevent evaporation
REMOVAL OF TEST SUBSTANCE
- Washing (if done):none
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- ca. 3.66
- Reversibility:
- not reversible
- Remarks on result:
- other: score for non-abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- ca. 0.16
- Reversibility:
- not reversible
- Remarks on result:
- other: score for non-abraded skin
- Irritant / corrosive response data:
- The results are presented for the abraded and non-abraded skin.
- Other effects:
- none reported
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material is irritating to the rabbit's skin.
- Executive summary:
Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited report, non GLP. The information in the report is limited to the information in the summary.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA, CFR, TitIe 21. para . 191. 12.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no details reported
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 40% - Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- 14 days, scored at 24, 48 and 72 hours and 4, 7 and 14 days after installation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: not reported - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1.5
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1.1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 2.9
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 3.1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- irritant
- Other effects:
- Not reported
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is a severe eye irritant
- Executive summary:
The test substance was installed in the eye of 6 rabbits. During the 14 day observation period severe eye irritation is observed. The test substance is considered to be an eye irritant category 1.
Reference
Animal no | 1 | 2 | 3 | |||||||||||||||
time | 24 | 48 | 72 | 4 | 7 | 14 | 24 | 48 | 72 | 4 | 7 | 14 | 24 | 48 | 72 | 4 | 7 | 14 |
cornea | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 1 | 1 | 1 |
iris | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 3 | 3 |
chemosis | 3 | 3 | 2 | 2 | 3 | 2 | 4 | 3 | 2 | 2 | 2 | 2 | 4 | 3 | 2 | 2 | 2 | 1 |
discharge | 3 | 3 | 3 | 2 | 2 | 2 | 3 | 3 | 2 | 2 | 2 | 2 | 3 | 3 | 3 | 2 | 2 | 2 |
Animal no | 4 |
|
|
|
|
| 5 |
|
|
|
|
| 6 |
|
|
|
|
|
time | 24 | 48 | 72 | 4 | 7 | 14 | 24 | 48 | 72 | 4 | 7 | 14 | 24 | 48 | 72 | 4 | 7 | 14 |
cornea | 2 | 2 | 2 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 |
iris | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness | 3 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
chemosis | 4 | 3 | 3 | 2 | 2 | 2 | 4 | 3 | 3 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 2 | 2 |
discharge | 3 | 3 | 3 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 2 | 2 | 3 | 3 | 3 | 2 | 2 | 2 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The available studies contain sufficient information to be used for risk assessment and classification and labelling. All tests are performed on a 40% formulation. It is not expected that the diluent used has contributed to the effects if any.
Justification for selection of skin irritation / corrosion endpoint:
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Exposure duration in both the irritation as well as the corrosion test represent a worst case situation.
Justification for selection of eye irritation endpoint:
Study was conducted prior to GLP regulations but used a method similar to OECD 405
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on the outcome of the available tests, the test substance needs to classified as skin irritant (CLP category 2, H315: Causes skin
irritation) and severe eye irritant (CLP category 1, H318: Causes serious eye damage).
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.

Route: .live1