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EC number: 464-700-1 | CAS number: 607724-42-5
- 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 test substance is not considered to be irritating to skin and 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 Mar. 22, 2005 to Apr. 29, 2005
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 2.2–2.9 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff® K-H (V2333), ad libitum and hay (approximately 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week under study conditions
- Temperature: 18±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From Mar. 22, 2005 to Apr. 29, 2005 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg
VEHICLE
- Amount applied: 0.3 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 h after removal of the patches. Because of persistent irritations 72 h after removal of the patches, additional readings were performed after 7 d with one animal. First animal exposed which had servere test item related skin discoloration was observed until the discoloration had disappeared (Day 15) to assess reversibility of discoloration.
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Preparaton of test site: About 24 h before the start of the study the hair in the dorsal region of the body of the 4 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: Warm tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Overall study design:
An initial test was performed using one animal. As no corrosive effects were observed in the initial test a confirmatory test with two further animals was conducted at first. A 4th animal had to be used for valid assessment because one animal was not assessable for erythema in the first study week due to test substance related discolorations. About 24 h before the start of the study the hair in the dorsal region of the body of the 4 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 0.5 g of test substance formed into a paste-like consistency with 0.3 mL of deionized water.The test substance was evenly distributed over the whole surface of a 2.5x2.5 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. Because of persistent irritations 72 h after removal of the patches, additional readings were performed after 7 d with one animal. First animal which showed severe test substance related skin discoloration was observed until the discoloration had disappeared (Day 15) to assess reversibility of discoloration. Erythema, eschar formation and edema were evaluated numerically according to the score of Draize. All other changes of the skin were recorded. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was found to be non-irritating to skin.
- Executive summary:
A study was conducted to assess the skin irritation potential of the test substance in New Zealand White rabbits according to EU Method B.4 and OECD Guideline 404, in compliance with GLP.
0.5 g of test substance was mixed with 0.3 mL of deionized water to form a paste-like consistency and applied as a single dose on the clipped dorsal surface of the test animals. As no corrosive effects were observed in the initial test, a confirmatory study with two further animals was conducted. A 4thanimal had to be added because one animal was not assessable for erythema in the first study week due test substance-related discoloration. The substance was evenly distributed over a surface of 2.5 x 2.5 cm using a semi-occlusive patch. The substance was washed with warm water after a 4 h exposure period. Examinations of the skin took place 30-60 minutes as well as 24, 48 and 72 h after removal of the patches. Because of persistent irritation 72 h after patch removal, additional readings were performed after 7 d with one animal. The animal which showed severe skin discoloration was observed until this had disappeared (Day 15). Erythema, eschar formation and edema were evaluated according to the score of Draize.
No clinical signs of systemic toxicity were observed. From 30-60 minutes up to 24 or 72 h after washing, two animals showed sporadically very slight up to well-defined erythema. Additionally, the skin surface was dry, rough and scaled. 7 d after washing, the irritation was reversed. A third animal showed no irritation.
Under the conditions of the study, the test substance was found to be non-irritating to skin.
Reference
One (1st) animal was not assessable for erythema in the first study week because of test substance related skin discoloration. Therefore, a 4thanimal was treated in addition to the remaining animals. 1st animal was not included in overall assessment.
30-60 minutes up to 24 or 72 h after decontamination the animals 2ndand 4thshowed sporadically very slight up to well-defined erythema. In case of 2ndanimal, erythema was not assessable due to the discoloration caused by the test item 30-60 minutes after decontamination.
Very slight up to slight edema were observed 24 h up to 72 h after decontamination in second animal. Additionally, the skin surface of the 2ndanimal was dry, rough and scaled. 7 d after decontamination the irritations were reversed. 3rd animal showed no irritations.
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 Apr. 19, 2005 to May 10, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 3.63 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Humidity: 50 ± 20 %
- Air changes:
IN-LIFE DATES: From: Apr. 19, 2005 To: May 10, 2005 - Vehicle:
- not specified
- Remarks:
- No vehicle used
- Controls:
- other: the untreated right eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 24 h after start of exposure with isotonic saline at approx. 37 °C
SCORING SYSTEM: as per OECD Guideline
TOOL USED TO ASSESS SCORE: fluorescein and UV light - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Irritant / corrosive response data:
- From 1 h up to 72 h after administration the conjunctiva showed definitely injected blood vessels up to a crimson red color and up to 24 h after treatment some swelling above normal up to obvious swelling with partial eversion of lids. 24 h after application the nictitating membrane of the animal was discolored by the test item up to the end of the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the substance caused discoloration of the nictitating membrane of rabbit eye until end of the study period. No other signs of irritation were observed.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in one NZW White rabbit according to OECD Guideline 405 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 the animal. The treated eye was washed out 24 h after administration. The untreated eye served as a control.
Overall mean scores for eye irritation were calculated to be 0.0 for iris and opacity of cornea, 1.33 for redness of conjunctiva and 0.33 for chemosis of conjunctiva. 24 h after the application, the nictitating membrane was discoloured by the test substance up to the end of the study. No clinical signs of systemic toxicity were seen. Body weight gain of the treated animal was not affected.
Due to the fact that a classification of R41 under DSD/DPD was warranted due to the non-reversible discolouration of the nictitating membrane, no further animals were tested due to animal welfare reasons. However, as only the conjunctivae of the rabbit eye were discoloured. And no other signs of eye irritation were found, following the criteria of Regulation (EU) 1272/2008, no classification applies in terms of serious eye irritation/eye damage.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A study was conducted to assess the skin irritation potential of the test substance in New Zealand White rabbits according to EU Method B.4 and OECD Guideline 404, in compliance with GLP. 0.5 g of test substance was mixed with 0.3 mL of deionized water to form a paste-like consistency and applied as a single dose on the clipped dorsal surface of the test animals. As no corrosive effects were observed in the initial test, a confirmatory study with two further animals was conducted. A 4thanimal had to be added because one animal was not assessable for erythema in the first study week due test substance-related discoloration. The substance was evenly distributed over a surface of 2.5 x 2.5 cm using a semi-occlusive patch. The substance was washed with warm water after a 4 h exposure period. Examinations of the skin took place 30-60 minutes as well as 24, 48 and 72 h after removal of the patches. Because of persistent irritation 72 h after patch removal, additional readings were performed after 7 d with one animal. The animal which showed severe skin discoloration was observed until this had disappeared (Day 15). Erythema, eschar formation and edema were evaluated according to the score of Draize. No clinical signs of systemic toxicity were observed. From 30-60 minutes up to 24 or 72 h after washing, two animals showed sporadically very slight up to well-defined erythema. Additionally, the skin surface was dry, rough and scaled. 7 d after washing, the irritation was reversed. A third animal showed no irritation. Under the conditions of the study, the test substance was found to be non-irritating to skin (Kauffmann, 2005d).
Eye irritation:
A study was conducted to assess the eye irritancy potential of the test substance in one New Zealand White rabbit according to OECD Guideline 405 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 the animal. The treated eye was washed out 24 h after administration. The untreated eye served as a control. Overall mean scores for eye irritation were calculated to be 0.0 for iris and opacity of cornea, 1.33 for redness of conjunctiva and 0.33 for chemosis of conjunctiva. 24 h after the application, the nictitating membrane was discolored by the test substance up to the end of the study. No clinical signs of systemic toxicity were seen. Body weight gain of the treated animal was not affected. Under the test conditions, the test substance was found to be non-irritating to the eyes (Kaufmann, 2005e).
Justification for classification or non-classification
Skin irritation:
Based on the results of a skin irritation study, the test substance does not need to be classified for this endpoint according to the EU CLP criteria (EC 1272/2008) as well as EU Directive 67/548/EEC.
Eye irritation:
Based on persistent staining of the nictitating membrane in one animal at the end of the observation period, the test substance is classified as R41 under EU Directive 67/548/EEC. However, as no discoloration of the cornea is observed in any of the rabbit eyes, the substance does not warrant classification according to EU CLP criteria (EC No 1272/2008).
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