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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-901-0 | CAS number: 5538-94-3
- 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 an unreliable in vivo skin irritation study, rabbits were administered dermally with the substance (50% active) for 24 hours. The animals were then observed at 24 hours and 48 hours post-exposure for any adverse effects. All animals were affected by eschar and odema formation. The animals went into immediate physiological decline and were all dead within 96 hours. Resultantly, the substance is considered to be highly toxic and corrosive to the skin following 24 hours exposure.
In a reliable in vivo skin irritation study New Zealand White rabbits were administered dermally with a structurally similar substance (unchanged) for 3-minutes. The animals were then observed at 1 hour, 24 hours, 48 hours, 72 hours, 7 days and 14 days post-exposure for any adverse effects including signs of erythma and oedema. Very slight erythma was noted at one treated skin site at 1 hour post-exposure and at two sites at the 24 hours post-exposure. Well defined erythma was noted at one exposed skin site at the 24 hours observation and two exposed skin sites at the 48 and 72 hour observation points. Desquamation or crust formation was noted at the 7 day obervation point. Crust formation was noted at one exposed skin site at the 14 day observation period. Resultantly, the substance is considered to be a skin irritant following a 3 minute exposure period.
In an unreliable in vivo eye irritation study six rabbits were administered with the substance (50% active) in the eyes. The animals were then observed at 24 hours, 48 and 72 hours post-exposure for any adverse effects. The parameters monitored were cornea opacity, iris appearance, and redness, chemosis and discharge of the conjunctivae. The test facilitators considered the substance to be highly toxic and corrosive to the eyes following exposure based on the findings from the observations.
In a reliable study, a single rabbit was administered a structurally similar substance (0.1 mL) in one eye. The substance was found to be extremely corrosive and the study was terminated by 1 hour following administration. The results show that the test material is corrosive to the eye.
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:
- 5th january 1995 - 19th January 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)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.48 - 2.66 kg
- Housing: metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days (minimum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 19°C
- Humidity (%): 43 - 65%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL.
- Duration of treatment / exposure:
- 3 minutes.
- Observation period:
- 72 hours.
- Number of animals:
- 3 animals
- Irritation parameter:
- erythema score
- Basis:
- other: Total
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: Total
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Very slight erythma was noted at one treated skin site at 1 hour post-exposure and at two sites at the 24 hours post-exposure. Well defined erythma was noted at one exposed skin site at the 24 hours observation and two exposed skin sites at the 48 and 72 hour observation points. Desquamation or crust formation was noted at the 7 day obervation point. Crust formation was noted at one exposed skin site at the 14 day observation period.
- Other effects:
- Desquamation or crust formation was also noted at the 7-day observation point.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The substance is considered to be a skin irritant following a 3 minute exposure period.
- Executive summary:
In an in vivo skin irritation study New Zealand White rabbits were administered dermally with the unchanged substance for 3-minutes. The animals were then observed at 1 hour, 24 hours, 48 hours, 72 hours, 7 days and 14 days post-exposure for any adverse effects including signs of erythma and oedema. Very slight erythma was noted at one treated skin site at 1-hour post-exposure and at two sites at 24 hours post-exposure. Well defined erythma was noted at one exposed skin site at the 24-hour observation and two exposed skin sites at the 48 and 72 hour observation points. Desquamation or crust formation was noted at the 7-day observation point. Crust formation was noted at one exposed skin site at the 14-day observation period. Resultantly, the substance is considered to be a skin irritant following a 3-minute exposure period.
Reference
Individual Scores - Rabbit Number and Sex | |||||
Skin Reaction | Observation Time | 41 Female | 50 Male | 52 Female | Total |
Erythma/Eschar Formation | 1 Hour | 1 | 0 | 0 | 1 |
24 Hours | 2 | 1 | 1 | 4 | |
48 Hours | 2 | 2 | 0 | 4 | |
72 Hours | 2 | 2 | 0 | 4 | |
7 Days | 1Cf | 0Cf | 0D | 1 | |
14 Days | 0Cf | 0 | 0 | 0 | |
Oedema Formation | 1 Hour | 0 | 0 | 0 | 0 |
24 Hours | 1 | 1 | 0 | 2 | |
48 Hours | 1 | 1 | 0 | 2 | |
72 Hours | 2 | 2 | 0 | 4 | |
7 Days | 0 | 0 | 0 | 0 | |
14 Days | 0 | 0 | 0 | 0 |
Cf: = crust formation D = desquamation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3rd June 1991 - 18th June 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 1 animal was employed for testing and the animal was maintained for 1 hour only due to the severity of the reaction.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 1 second exposure followed by observations at 1, 24, 48 and 72 hours.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours.
- Number of animals or in vitro replicates:
- 1 animal.
- Other effects / acceptance of results:
- The substance was very corrosive and the animal was sacrificed after 1 hour.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 94
- Max. score:
- 94
- Reversibility:
- not reversible
- Remarks on result:
- not determinable
- Remarks:
- Due to excessive corrosivity.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance was corrosive as noted within an hour of substance administration to a single animal eye.
- Executive summary:
A single rabbit was administered the test substance (0.1 mL) in one eye. The substance was found to be extremely corrosive and the study was terminated by 1 hour following administration. The results shows that the test material is corrosive to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on reliable skin and eye irritation studies on a structurally similar substance, as well as unreliable studies on the substance itself, the substance is classified as corrosive to the skin (Skin Corr. 1B, H314).
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.