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EC number: 438-930-8 | CAS number: 2550-52-9
- 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
Skin irritation/corrosion (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
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:
- 12 - 16 Feb 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)
- Version / remarks:
- (1992)
- Deviations:
- yes
- Remarks:
- occlusive instead of semi-occlusive dressing; 4 test substance concentrations were tested; 4 rabbits instead of 3 rabbits were used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (Commission Directive 92/69/EEC)
- Deviations:
- yes
- Remarks:
- 4 substance concentrations were tested
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF Crl:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2465 - 2720 g
- Housing: in stainless steel cages (50 x 55 x 40 cm) with bottom grid of oval steel and with tub for faeces, granulated soft wood bedding
- Diet: ALTROMIN 2123 standard diet for rabbits (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 22.5
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12 / 12
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: mixture of ethanol/diethylphthalate 1:1 (v/v)
- Remarks:
- (used for moistening of the test substance)
- Controls:
- yes, concurrent no treatment
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentrations: 10, 25, 50% [w/v], 100% (undiluted)
VEHICLE
- Amount applied: 0.5 mL
- Lot/batch no.: S31826035 (Diethylphthalate), 46047117 (Ethanol) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 4 males
- Details on study design:
- TEST SITE
- Area of exposure: three pairs of areas of approx. 4 x 5 cm at the dorsal area of the trunk so that one of each pair lies on each side of the spine
- Type of wrap if used: one layer of gauze patch (two layers of gauze patch for test substance solutions and for the vehicle) covered with aluminium foil, which was held in contact with the skin by occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: The application area was rinsed with a mixture of ethanol/diethylphthalate 1:1 (v/v) without altering the integrity of the epidermis.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All skin areas, treated with the moistened original test item or with solutions of the test item in the vehicle (50, 25 and 10 % [w/v]) and also the control skin areas (untreated and treated with vehicle), did not show any alterations at any observation time.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the Acute Dermal Irritation/Corrosion Test in rabbits the test substance does not possess any skin irritating potential.
- Executive summary:
The skin irritation potential of the test substance was determined by an in vivo skin irritation test (2001) in albino rabbits according to OECD Guideline 404 and in compliance with GLP. 0.5 g of the crushed test substance moistened with ethanol/diethylphthalate 1:1 (v/v) and 0.5 mL of the test substance in dilutions of 10, 25 and 50% (w/v) in ethanol/diethylphthalate 1:1 (v/v) were applied to the skin of four rabbits under occlusive conditions for 4 hours. After the exposure period the patch was removed and the administration areas were rinsed with ethanol/diethylphthalate 1:1 (v/v) . Scores were taken 1, 24, 48 and 72 hours after patch removal using the Draize scoring system. All skin areas, treated with the undiluted or with one of the three solutions of the test substances, did not show any alterations at any observation time point. The overall mean score after 24, 48 and 72 hours for erythema and edema of all animals was 0. Based on the results, the undiluted test substance as well as the 10, 25 and 50% (w/v) solutions were not irritating to the skin under the conditions of the test.
Reference
No animal died during the course of investigation and no clinical signs were observed. Necropsy was not carried out, because no clinical signs were observed.
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:
- 27 Feb - 03 Mar 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (Commission Directive 92/69/EEC)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF Crl:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2955 - 3292 g
- Housing: in stainless steel cages (50 x 55 x 40 cm) with bottom grid of oval steel and with tub for faeces, granulated soft wood bedding
- Diet: ALTROMIN 2123 standard diet for rabbits (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 22.5
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
The test substance was crushed with a pestle and mortar to a fine dust before application. - Duration of treatment / exposure:
- 24 hours
single application without washing - Observation period (in vivo):
- 72 hours
Reading time points: 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- A slight redness of the conjunctivae (score 1) of the treated eyes was observed in all four animals on the day of instillation and in three animals until 24 hours after exposure. A slight swelling of the conjunctivae (score 1) was observed in all four animals on the day of exposure and in two animals until 24 hours after exposure. The cornea and iris were not affected. 48 hours after exposure no signs of irritation were observed. The control eyes of the animals showed no alterations at any observation time.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.
- Executive summary:
The eye irritation potential of the test substance was investigated in four albino rabbits according to OECD Guideline 405 (1987) and in compliance with GLP. 0.1 g of the test substance, which was crushed to a fine dust, was placed in one eye of each animal. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 1, 24, 48 and 72 hours after application. A slight redness of the conjunctivae (score 1) of the treated eyes was observed in all four animals on the day of instillation and in three animals until 24 hours alter instillation. A slight swelling of the conjunctivae (score 1) was observed in all four animals on the day of instillation and in two animals until 24 hours after instillation.The cornea and iris were not affected. The mean scores at 24/48/72 of all 4 animals for redness, chemosis, cornea and iris was 0.25, 0.17, 0 and 0, respectively. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.
Reference
Table 1. Results of the eye irritation study
Alteration |
Animal No. |
Time (h) |
|||||
1 |
24 |
48 |
72 |
mean 24/48/72 |
Overall mean (24/48/72)/ 4 animals |
||
Cornea |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
||
4 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
||
4 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae Redness |
1 |
1 |
1 |
0 |
0 |
0.33 |
0.25 |
2 |
1 |
0 |
0 |
0 |
0 |
||
3 |
1 |
1 |
0 |
0 |
0.33 |
||
4 |
1 |
1 |
0 |
0 |
0.33 |
||
Conjunctivae Chemosis |
1 |
1 |
1 |
0 |
0 |
0.33 |
0.17 |
2 |
1 |
0 |
0 |
0 |
0 |
||
3 |
1 |
1 |
0 |
0 |
0.33 |
||
4 |
1 |
0 |
0 |
0 |
0 |
No animal died during and no clinical signs were observed during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin irritation potential of the test substance was determined by an in vivo skin irritation test (2001) in albino rabbits according to OECD Guideline 404 and in compliance with GLP. 0.5 g of the crushed test substance moistened with ethanol/diethylphthalate 1:1 (v/v) and 0.5 mL of the test substance in dilutions of 10, 25 and 50% (w/v) in ethanol/diethylphthalate 1:1 (v/v) were applied to the skin of four rabbits under occlusive conditions for 4 hours. After the exposure period the patch was removed and the administration areas were rinsed with ethanol/diethylphthalate 1:1 (v/v) . Scores were taken 1, 24, 48 and 72 hours after patch removal using the Draize scoring system. All skin areas, treated with the undiluted or with one of the three solutions of the test substances, did not show any alterations at any observation time point. The overall mean score after 24, 48 and 72 hours for erythema and edema of all animals was 0. Based on the results, the undiluted test substance as well as the 10, 25 and 50% (w/v) solutions were not irritating to the skin under the conditions of the test.
Eye
The eye irritation potential of the test substance was investigated in four albino rabbits according to OECD Guideline 405 (1987) and in compliance with GLP. 0.1 g of the test substance, which was crushed to a fine dust, was placed in one eye of each animal. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 1, 24, 48 and 72 hours after application. A slight redness of the conjunctivae (score 1) of the treated eyes was observed in all four animals on the day of instillation and in three animals until 24 hours alter instillation. A slight swelling of the conjunctivae (score 1) was observed in all four animals on the day of instillation and in two animals until 24 hours after instillation.The cornea and iris were not affected. The mean scores at 24/48/72 of all 4 animals for redness, chemosis, cornea and iris was 0.25, 0.17, 0 and 0, respectively. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.
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