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EC number: 609-256-3 | CAS number: 365400-11-9
- 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 (OECD 404), rabbit: not irritating
Eye irritation (EPA OPPTS 870.2400), rabbit: 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:
- 14 Apr - 17 May 2004
- 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:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 Jul 2015
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was pulverized. - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: approximately 6 months
- Weight at study initiation: 3020 - 3175 g
- Housing: individually in metal cages with excrement tray
- Diet: "Ssniff K-2" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, Soest, Germany), approximately 100 g/animal/day; once per day in the moming
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): approximately 12/12
IN-LIFE DATES: From: 14 Apr 2004 To: 17 Apr 2004 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Remarks:
- (approximately 24 h before application)
- Vehicle:
- water
- Controls:
- other: the untreated contralateral skin area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 - 502 mg
- Duration of treatment / exposure:
- 1st animal: 3 min, 1 h, 4 h
2nd and 3rd animal: 4 h - Observation period:
- 72 h
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied to the dorsolateral area of the trunk (treated skin was approximately 2.5 x 2.5 cm in size).
- Type of wrap if used: The test material was moistened with sterile water and was covered with a gauze patch which was held in place with "Surgifix No. 5" (Schumacher, Medical Produkte, Krefeld, Germany)
REMOVAL OF TEST SUBSTANCE
- Washing: The exposed skin was carefully washed with water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1st animal: immediately after patch removal (3 min and 1 h treatment); 1, 24, 48 and 72 h after patch removal (4 h treatment)
2nd and 3rd animal: 1, 24, 48 and 72 h after patch removal
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals (4 h treatment)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals (4 h treatment)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation or corrosion were noted after treatment for 3 min or 1 h. No signs of irritation or corrosion were noted immediately after treatment for 4 h.
- Other effects:
- - Other adverse systemic effects: There were no relevant systemic intolerance reactions.
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The study was performed in accordance to OECD TG 404 under GLP conditions and is considered reliable. The test substance was non-irritant.
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:
- 13 Dec - 16 Dec 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)
- Version / remarks:
- adopted 09 Oct 2017 (corrected 14 Jun 2021)
- Deviations:
- yes
- Remarks:
- no pre-treatment with systemic analgesic and topical anesthesia
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted 1998
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was instilled as received. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC, USA
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors.
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied, ad-libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 Dec 2005 To: 16 Dec 2005 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 40 mg (corresponding to 0.1 mL) - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done
SCORING SYSTEM: scoring was done according to Draize
TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite). A fluorescein dye evaluation was performed 24 h after instillation and as needed at subsequent scoring intervals to evaluate the extent of corneal damage or to verify reversal of effects. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1 and animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of corneal opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1 and animal # 3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of iritis
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all aniamls
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of chemosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2 and animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis. By 24 h, corneal opacity (score 1) developed in one animal. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 72 h.
Ocular discharge (score 2) was noted 1 h after treatment and to a lesser degree (score 1) 24 h after treatment in all animals. In animal #3 this discharge persisited until 48. The finding was fully reversible in all animals within 72 h. - Other effects:
- All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008"
- Conclusions:
- The study was performed in accordance to EPA OPPTS 870.2400 (Acute Eye Irritation) under GLP conditions and is considered reliable. Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 20 Apr - 18 May 2004
- 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:
- adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 9 Oct 2017 (corrected 14 Jun 2021)
- Deviations:
- yes
- Remarks:
- no pre-treatment with systemic analgesic and topical anesthesia
- GLP compliance:
- yes
- Specific details on test material used for the study:
- FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was pulverized.
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: approximately 3 months
- Weight at study initiation: 2314 - 2815 g
- Housing: individually in metal cages with excrement trays
- Diet: "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, Soest, Germany), approximately 100 g/animal/day; once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Apr 2004 To: 27 Apr 2004 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 101 - 102 mg
- Duration of treatment / exposure:
- single application with washing 1 h after instillation
- Observation period (in vivo):
- 7 days
Reading time points 1, 24, 48, 72 h and 7 days after treatment - Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were washed 1 h following instillation.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Fluorescein staining was conducted at 24 h after compound instillation. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of corneal opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of iritis
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Lacrimation (score 1) was noted 1 h after treatment in all animals and 24 h after treatment in animal #1. This finding was fully reversible in all animals within 48 h.
- Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- The study was performed in accordance to OECD TG 405 under GLP conditions and is considered reliable. Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.
Referenceopen allclose all
Table 1: Individual irritation scores
Animal number |
Effects |
1 h |
24 h |
48 h |
72 h |
Mean scores* |
1 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 1 3 1 2 |
0 1 2 0 1 |
0 0 1 0 0 |
0 0 0 0 0 |
0.00 0.33 1.00 0.00 0.33 |
2 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 1 2 1 2 |
0 0 2 1 1 |
0 0 1 0 1 |
0 0 0 0 0 |
0.00 0.00 1.00 0.33 0.67 |
3 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 1 3 2 2 |
1 1 2 1 1 |
1 0 1 1 1 |
0 0 0 0 0 |
0.67 0.33 1.00 0.67 0.67 |
* calculated from 24 to 72 h scores
Table 1: Individual mean irritation scores
Animal number |
Effects |
1 h |
24 h |
48 h |
72 h |
7 d |
Mean scores* |
Reversible |
1 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Lacrimation |
0 0 2 2 1 |
0 0 2 1 1 |
0 0 2 0 0 |
0 0 1 0 0 |
0 0 0 0 0 |
0.00 0.00 1.67 0.33 0.00 |
na na 7 d 48 h 48 h |
2 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Lacrimation |
0 0 2 2 1 |
0 0 1 1 0 |
0 0 0 0 0 |
0 0 0 0 0 |
- - - - - |
0.00 0.00 0.33 0.33 0.00 |
na na 48 h 48 h 24 h |
3 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Lacrimation |
0 0 2 2 1 |
0 0 2 1 0 |
0 0 1 0 0 |
0 0 0 0 0 |
- - - - - |
0.00 0.00 1.00 0.33 0.00 |
na na 72 h 48 h 24 h |
* calculated from 24 to 72 h scores, na = not applicable, - not examined
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable in vivo studies regarding eye and skin irritation/corrosion are available.
Skin:
In a primary dermal irritation study (performed according to OECD 404, in compliance with GLP, M-003613-01-3), 3 female New Zealand Albino rabbits were dermally exposed to 0.5 g test substance moistened with water for 4 h under semiocclusive conditions. Animals then were observed for 3 days. Irritation was scored by the method of Draize as described in the OECD 404. The mean scores for the 24, 48 and 72 h reading for erythema and edema for each animal was 0, respectively. No skin reactions were observed at the 1-hour reading point. In this study, the test substance was not a dermal irritant.
Eye:
An eye irritation test was performed with three female New Zealand Albino rabbits according to OPPTS 870.2400 in compliance with GLP (M-267442-01-1). Eyes were not washed after application of 0.1 mL (corresponding to 0.04 g) test substance and the animals were observed for 3 days. Irritation was scored by the method of Draize. One hour after test substance instillation, all three treated eyes exhibited iritis (score 1 for all animals) and conjunctivitis (score 3 for 2 animals, score 2 for one animal). By 24 h, cornea opacity (score 1) developed in one animal but was fully reversible at 72 h. No cornea opacity developed in the other two animals. Mean scores (24, 48, 72 h) for cornea opacity are 0, 0 and 0.67, respectively. Also iritis (score 1) was noted at 24 h in 2/3 animals being fully reversible within 48 h and resulting in mean iritis scores (24, 48, 72 h) of 0.33, 0.00 and 0.33, respectively. Moderate conjunctival irritation (grade 1-2) were observed in 3/3 animals but were fully reversible within 72 h in all animals. Mean scores (24, 48, 72 h) regarding conjunctival irritation were 1.00 for all animals. Chemosis (grade 1) was also noted in 2/3 animals but was fully reversible within 48 h. Mean scores (24, 48, 72 h) for chemosis were 0, 0.33 and 0.67, respectively. All animals were free of ocular irritation by 72 h.
Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.
A second eye irritation test was performed with three female New Zealand Albino rabbits and performed according to OECD 405 in compliance with GLP (M-003615-01-1). Eyes were washed 1 h after application of 0.1 g test substance and the animals were observed for 7 days. Irritation was scored by the method of Draize. The mean scores for the 24-, 48- and 72-h reading for iritis and cornea opacity were 0 for each animal. Moderate conjunctival irritation (mean scores for the 24-, 48- and 72 h-reading: 1.67, 0.33 and 1.0, respectively) were observed in 3/3 animals but were fully reversible within 72 h in 2/3 animals and 7 days in 1/3 animals. Chemosis (mean scores for the 24-, 48- and 72 h-reading: 0.33 for each animal) was also noted in 3/3 animals but was fully reversible within 48 h.
Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.