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EC number: 432-550-6 | CAS number: 243858-01-7
- 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 non-irritating to the skin or eye of rabbits. It caused discolouration of conjunctivae, nictitating membranes and sclera which were not completely reversed at the end of the observation period.
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 August 17, 1999 to August 20, 1999
- 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.
- Body weight range at treatment: 2.8-3.4 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (i.e., approximately 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Numbered ear tags
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: August 17, 1999 to August 20, 1999 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg (i.e., 0.5g)
- 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:
- 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 0.5 g test substance pasted with 0.5 mL deionized water. The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (i.e., 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
- Other effects:
- 30 - 60 min up to 1 d after removal of the plaster the animals showed orange discolored skin.
3 d after administration all discolorations were disappeared. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritating to skin.
- Executive summary:
A study was performed to assess the skin irritation potential of the test substance in femaleNew Zealand albino rabbit according to OECD Guideline 404 and EU Method B.4, in compliance with GLP.
500 mg of test substance pasted with 0.5 mL deionized water was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. 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 with warm tap water. Animals were scored for irritation reactions after 30 - 60 min, and at 24, 48 and 72 h.
Except for orange discolored skin in treated animal up to 1 d after removal of the plaster, no severe signs of irritation were observed during the whole observation period. Further, all discolorations were reversiblewithin 3 d. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.00 for edema formation.
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 August 24, 1999 to September 14, 1999
- 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:
- yes
- Remarks:
- only one animal was tested. As the persistent discolouration of the conjunctivae requested a classification according to EU Directive 67/548/EEC, no further animals were tested.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Charles River Deutschland GmbH, 88353 Kisslegg.
- Body weight at treatment: 3.0 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (i.e., approximately 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Numbered ear tags
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: August 24, 1999 to September 14, 1999 - 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 after 7, 14 d and 21 d following administration of the test substance.
- Number of animals or in vitro replicates:
- 1 female
- Details on study design:
- TEST PROCEDURE
About 24 h before the start of the study the test 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.
100 mg test substance was administered once to the conjunctival sac of the left eye of one rabbit. In each case the untreated eye served as a control. 24 h after administration the treated eye was washed out thoroughly with isotonic saline at approximately 37ºC. The eye was also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
The eye was examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7, 14 and 21 d, the eye was 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 eye after 72 h, further examinations were carried out after 7, 14 and 21 d. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score)
- 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
- Irritant / corrosive response data:
- - From 1 h up to 1 d after application the conjunctiva of the animal showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed.
- The irritations were attended by clear substance coloured eye discharge.
- 2 d after application the irritations were reversed.
- Additionally, nictitating membrane, conjunctiva and sclera were discolored orange from 1 h up to the end of the study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictitating membrane and sclera of one rabbit eye until end of the study period. Reddening of the conjunctiva was seen after substance application but this cleared within two days.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in one New Zealand albino female 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.
The conjunctiva, nictitating membrane and sclera were discolored orange by the test substance up to the end of the study. The conjunctiva showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed, accompanied by clear substance coloured eye discharge on the day of substance administration. Based on the individual scores after 24, 48 and 72 h, the mean score was 0 for opacity of the cornea, iris and chemosis of the conjunctiva. The score was 0.33 for redness of the conjunctiva.
Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictitating membrane and sclera of one rabbit eye until end of the study period. Reddening of the conjunctiva was seen after substance application but this cleared within two days.
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 performed to assess the skin irritation potential of the test substance in female New Zealand albino rabbit according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. 500 mg of test substance pasted with 0.5 mL deionized water was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. 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 with warm tap water. Animals were scored for irritation reactions after 30 - 60 min, and at 24, 48 and 72 h. Except for orange discolored skin up to 1 d after removal of the plaster, no severe signs of irritation were observed in treated animals during the whole observation period. Further, all discolorations were reversible within 3 d. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.00 for edema formation. Under the test conditions, the test substance was considered to be non-irritating to skin (Seeberger, 1999b).
Eye Irritation:
A study was conducted to assess the eye irritancy potential of the test substance in one New Zealand albino female 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. The conjunctiva, nictitating membrane and sclera were discolored orange by the test substance up to the end of the study. The conjunctiva showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed accompanied by clear substance coloured discharge on the day of substance administration. Based on the individual scores after 24, 48 and 72 h, the mean score was 0 for opacity of the cornea, iris and chemosis of the conjunctiva. The score was 0.33 for redness of the conjunctiva. Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictitating membrane and sclera of one rabbit eye until end of the study period. Reddening was seen in the conjunctiva but this cleared within 2 days (Seeberger, 1999c).
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 skin irritation potential according to the EU CLP criteria (EC 1272/2008) as well as EU Directive 67/548/EEC.
Eye irritation:
Based on persistent discolouration of conjunctivae, nictitating membranes and iris until the end of the observation period (one animal), the test substance was classified as Xi; 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 have to be classified as causing serious damage to eyes according to the CLP Regulation (EC 1272/2008). No classification for irritating effects to the eyes is therefore required.
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