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EC number: 443-090-0 | 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 did not cause irritation to skin or eyes
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:
- From October 16, 2001 to October 19, 2001
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR (N.Zeal.White)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Body weight at start of study: 3.25–3.91 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet: ssniff K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Ear tags and cage numbering
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: October 16, 2001 to October 19, 2001 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg per patch
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 minutes as well as 24, 48 and 72 h after removal of the patches
- Number of animals:
- 3 females
- Details on study design:
- ROUTE OF ADMINISTRATION: Dermal
FREQUENCY OF ADMINISTRATIONS: single dose
PREPARATION OF THE TEST SUBSTANCE:
Each animal was treated with 500 mg of test substance pasted with 0.4 mL deionized water.
TEST PROCEDURE:
About 24 h before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used. Each animal was treated with 500 mg of test substance pasted with 0.4 mL deionized water. The test substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 h.
After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 h after removal of the patches.
Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.
SCORING SYSTEM:
Erythema and eschar formation
No erythema........................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................1
Well-defined erythema ......................................................................................................2
Moderate to severe erythema............................................................................................3
Severe erythema (beet redness) to eschar formation (injuries in depth) preventing
grading of erythema...........................................................................................................4
Not assessable.....................................................................................................................*
Edema
No edema..............................................................................................................................0
Very slight edema (barely perceptible).............................................................................1
Slight edema (edges of area well defined by definite raising).......................................2
Moderate edema (raised approximately 1 mm) ..............................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4
Not assessable......................................................................................................................* - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritations were observed during the study.
- Other effects:
- No abnormalities detected during clinical observations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritant to skin.
- Executive summary:
A study was performed to assess the skin irritation potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 404, EPA OPPTS 870.2500 and EU Method B.4, in compliance with GLP.
500 mg of test substance pasted with 0.4 mL deionized water was evenly distributed over the whole surface of a cellulose patch on a piece of surgical plaster of 2.5 x 2.5 cm. The plaster was fixed to the prepared skin area of about 25 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed from the skin with warm tap water. Animals were scored for irritation reactions after 30 - 60 minutes, and at 24, 48 and 72 h.
No skin irritation was observed in treated animals.
Under the test conditions, the test substance was considered to be non-irritating to skin.
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:
- From October 23, 2001 to November 06, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR (N.Zeal.White)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Body weight at start of study: 2.4–3.1 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet: ssniff K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Ear tags and cage numbering
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (except short lasting deviations due to disturbances of air condition)
- Humidity: 50±20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: October 23, 2001 to November 06, 2001 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 , 72 h and and after 7 d following administration of the test substance.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- ROUTE OF ADMINISTRATION: conjunctival
FREQUENCY OF ADMINISTRATIONS: single dose
PREPARATION OF THE TEST SUBSTANCE:
Each animal was treated with 100 mg of test substance
TEST PROCEDURE
About 24 h before the start of the study both eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
0.1 mg of test substance was administered once to the conjunctival sac of the left eye of three rabbits. In each case the untreated eye served as a control. 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approximately 37°C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7 d, the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded when apparent. Since effects were still present in the eyes after 72 h, further examinations were carried out after 7 d. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1 h up to 72 h after administration the conjunctivae of the animals showed definitely injected blood vessels up to crimson colour. 1 h up to 24 h after administration the conjunctivae of the animals showed slight up to obvious swelling. Furthermore, two animals showed bleedings of the nictitating membrane from 24 h up to 72 h after administration. In addition to these observations, serous eye discharge discolored by the substance was noted. 7 d after administration all signs of irritation had disappeared.
- Other effects:
- No clinical signs of systemic toxicity were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was considered to be not irritating to eyes.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP.
A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were washed out 24 h after the administration of the test substance. The untreated eyes served in each case as a control.
Except for conjunctivae redness and chemosis which were fully reversible within 7 d, no severe irritating effects were observed. Further, no clinical signs of systemic toxicity were seen.
Under the test conditions, the test substance was considered to be not irritating to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was performed to assess the skin irritation potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 404, EPA OPPTS 870.2500 and EU Method B.4, in compliance with GLP. 500 mg of test substance pasted with 0.4 mL deionized water was evenly distributed over the whole surface of a cellulose patch on a piece of surgical plaster of 2.5 x 2.5 cm. The plaster was fixed to the prepared skin area of about 25 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed from the skin with warm tap water. Animals were scored for irritation reactions after 30 - 60 minutes, and at 24, 48 and 72 h. No skin irritation was observed in treated animals. Under the test conditions, the test substance was considered to be non-irritating to skin.
A study was conducted to assess the eye irritancy potential of the test substance in Crl:KBL(NZW)BR female rabbits according to OECD Guideline 405, EPA OPPTS 870.2400 and EU Method B.5, in compliance with GLP. A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of each animal. The treated eyes were washed out 24 h after the administration of the test substance. The untreated eyes served in each case as a control. Except for conjunctivae redness and chemosis which were fully reversible within 7 d, no severe irritating effects were observed. Further, no clinical signs of systemic toxicity were seen. Under the test conditions, the test substance was considered to be not irritating to eyes.
Justification for classification or non-classification
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.
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