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EC number: 700-945-5 | 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
The substance is not irritating to the skin or 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:
- Between 15 January 1985 and 5 February 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted using a method similar to an existing guideline but not complying will aspects of currrent guidelines.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. 40 CFR Section 163.81-5 Federal Register August 22., 1978
- Deviations:
- not specified
- Principles of method if other than guideline:
- A group of six rabbits was clipped over a wide area of their backs approximately 24 hours prior to application. The skin remained intact. A dose of 0.5 ml of liquid was applied to the test site. Adjactent areas served as the control. A guaze patch was placed over the treated area and was held in place by a non-irritating tape and then covered by a semi-occullllsive dressing. The wrapping and tape were removed after 4 hours follwed by washing of the site with water. The treated areas were examined for signs of erythema and edema using the Draize method within 30-60 minutes of removal and at 24, 48, and 72 hours.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent site used as control
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes and 24, 48, and 72 hours
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 Hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 Hours
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 Hours
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 Hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 Hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 Hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.
- Executive summary:
A dose of 0.5 ml was applied to the intact skin of six rabbits; the adjacent skin was used as a control. After 4 hours exposure the guaze, tape, and semi-occulsive bandage were removed. The skin of each animal was evaluated according to the method of Draize within 30 -60 minutes of removal of the bandages and test material with water and at 24, 48, and 72 hours. The mean 24, 48, and 72 hour erythema and edema scores were 0.84 and 0.11, respectively. Erythema showed some evidence of reversibility but was not fully reversible at 72 hours. Edema was fully reversible by 48 hours. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.
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
- Study period:
- Between 28 January 1985 and 5 February 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in a manner similar to an existing guideline but does not meet all of the current guideline requirements.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U.S. 40 CFR Section 163.81-4 Federal Register August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of November 1982
- Deviations:
- not specified
- Principles of method if other than guideline:
- A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the othere eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye served as the untreated control.
- Amount / concentration applied:
- 0.1 ml of the test material
- Duration of treatment / exposure:
- Single dose without washing through 7 day observation period
- Observation period (in vivo):
- 1 hour and the 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 2 day ( 48 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 3 day (72 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 2 day (48 hour)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 3 day (72 hours)
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Reversibility:
- other: No irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 2 day (48 hours)
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3 day(72 hours)
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0.33
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0.5
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 day (24 hours)
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 2 day (48 hours)
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 3 day (72 hours)
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 4 day
- Score:
- 0.67
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0.5
- Reversibility:
- not fully reversible within: 7 days
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.
- Executive summary:
A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the other eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed. The mean 24, 48, and 72 hour mean cornea, iris, conjuctival erythema and chemosis were 0.0, 0.0, 0.78, and 0.89, respectively. Conjunctival erythema and chemosis showed some evidence of reversibility but was not fully reversible by day 7 when the study was terminated. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
A dose of 0.5 ml was applied to the intact skin of six rabbits; tha adjacent skin was used as a control. After 4 hours exposure the gauze, tape, and semi-occulsive bandage were removed. The skin of each animal was evaluated according to the method of Draize within 30 -60 minutes of removal of the bandages and test material with water and at 24, 48, and 72 hours. The mean 24, 48, and 72 hour erythema and edema scores were 0.84 and 0.11, respectively. Erythema showed some evidence of reversibility but was not fully reversible at 72 hours. Edema was fully reversible by 48 hours. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.
Eye
A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the othere eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed. The mean 24, 48, and 72 hour mean cornea, iris, conjuctival erythema and chemosis were 0.0, 0.0, 0.78, and 0.89, respectively. Conjunctival erythema and chemosis showed some evidence of reversibility but was not fully reversible by day 7 when the study was terminated. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.
Justification for classification or non-classification
Under the conditions of the studies, the test material is not irritating to the skin or the eye of rabbits. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for irritation effects
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