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EC number: 944-574-9 | CAS number: -
- 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 - Not irritation to the skin of rabbits
Eye - Not irritating in vivo to the eye of rabbits.
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:
- 02 March 1974 to 18 April 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US Federal Hazardous Substances Labelling Act
- Principles of method if other than guideline:
- The method employed in the testing was similar to that described in Section 1500.41 - Hazardous Substances and Articles. Administration and Enforcement Regulations, Federal Register, Vol 38 No 187 P.27019, 27 September 1973. Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used
- GLP compliance:
- no
- Remarks:
- Prior to GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No details on test animals and environment provided
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Clipped with abraded and intact sites on each animal
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 24 hour occlusive exposure. The sites were not washed after the patches were removed.
- Observation period:
- 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 & 72 houts
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Intact skin only
The test item elicited a well defined erythema response in all animals at the 24 and 72 hour observation. No other irritation response were noted. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.
- Executive summary:
Introduction
The study was performed in accordance with the US Federal Hazardous Substances Labelling Act to assess the irritancy potential of the test item to the skin of rabbits.
Method and materials
The intact and abraded skin of 6 rabbits was used. The hair was clipped from the backs of the rabbits. One side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. GauzE patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used.
Results
A single 24-Hour, occluded application of the test item to the intact skin of six rabbits produced a well defined erythema response in all six animals at the 24 & 72 -hour observation No other irritation responses were noted.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.
Reference
Irritation effects on the intact skin only are considered for classification purposes.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Hazardous Substances Labeling Act
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Six rabbits were used in this study, 0.1g of the test material was instilled into the right eyes of the animals, the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1,2 and 3 days following instillation.
- GLP compliance:
- no
- Remarks:
- Prior to GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No details on test animals and environment provided
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Days 1, 2, 3
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Illustrated Guide for Grading Eye Irritation by Hazardous Substances - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, & 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effect observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effect observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: No effect observed
- Irritant / corrosive response data:
- No effects shown
- Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not an irritant to the eyes of rabbit under the conditions of the study. The test item is not classifiable under CLP.
- Executive summary:
Introduction
The study was performed in accordance with the US Federal Hazardous Substances Labelling Act.
Method
A volume of 0.1g of the test item was placed into one eye of six rabbits. The eyes were left unwashed and observations were perfomed on day 1 and then daily for a period of 3 days. Assessment of ocular damage/irritation was made according to the Illustrated gide for Grading Eye Irritation by Hazardous Substances
Results
A single application of the test item to the non-irrigated eye of six rabbits produced no effects.
Conclusion
The test material is not an irritant in the eye of rabbits. The test item is not classifiable under CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
SKIN
The study was performed in accordance with the US Federal Hazardous Substances Labelling Act to assess the irritancy potential of the test item to the skin of rabbits. The intact and abraded skin of 6 rabbits was used. The hair was clipped from the backs of the rabbits. One side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used
A single 24-Hour, occluded application of the test item to the intact skin of six rabbits produced a well defined erythema response in all six animals at the 24 & 72 -hour observation No other irritation responses were noted.
Supporting date for the Acute Dermal Toxicity Study, showed individual dermal reactions for up to 14 days and there were no effects seen.
In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.
EYE
The study was performed in accordance with the US Federal Hazardous Substances Labelling Act. A volume of 0.1g of the test item was placed into one eye of six rabbits. The eyes were left unwashed and observations were perfomed on day 1 and then daily for a period of 3 days. Assessment of ocular damage/irritation was made according to the Illustrated gide for Grading Eye Irritation by Hazardous Substances
A single application of the test item to the non-irrigated eye of six rabbits produced no effects. The test material is not an irritant in the eye of rabbits. The test item is not classifiable under CLP.
Justification for selection of skin irritation / corrosion endpoint:
Pre-GLP study providing adequate description of experimental methods.
Justification for selection of eye irritation endpoint:
Pre-GLP study providing adequate description of experimental methods.
Justification for classification or non-classification
SKIN
In the dermal irritation study, treatment with the test item resulted in erythema scores of 2 and edema scores of 0 in six animals at 24 and 72 hours, which is not sufficient for the substance to be classified under the terms of EU CLP Regulation (EC) No. 1272/2008.
EYE
Treatment with the test item caused no effects (cornea, iris and conjunctivae scores 0 at 24, 48 and 72 hours), which is not sufficient for the substance to be classified under the terms of EU CLP Regulation (EC) No. 1272/2008.
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