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EC number: 226-073-0 | CAS number: 5261-99-4
- 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
Key study: Skin irritation. OECD guideline and EU method. GLP study.
Based on the available results, the test substance is not classified as skin irritating.
Key study: Eye irritation OECD guideline and EU method. GLP study.
Based on the available results, the test substance is not classified as eye 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:
- From 06 December 2012 to 04 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP 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 (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of Occupational Medicine, Łódź
- Age at study initiation: The experiment was conducted on one 5-month-old female and two females which were 5.5 months old.
- Weight at study initiation: 3.2-4.4 kg
- Housing: The animals were kept individually in metal cages with the following dimensions: 60 x 35 x 40 cm (length x width x height).
- Diet (e.g. ad libitum): LSK standard granulated laboratory fodder, ad libitum
- Water (e.g. ad libitum): drinking tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 35 – 68%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark
IN-LIFE DATES: From: 7 December 2012 To: 15 December 2012 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: drenched with a few drops of water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after the end of the treatment.
- Number of animals:
- Three females
- Details on study design:
- TEST SITE
- Area of exposure: The area of skin treated with the test item was about 6 cm2.
- Type of wrap if used: The test item was applied to a multilayer gauze patch (2.5 x 2.5 cm) and drenched with a few drops of water. The gauze patch was laid on the prepared skin. The gauze patch was covered with PVC foil and protected using a non-irritating sticking plaster. The rabbit’s trunk was covered with lignin, and an elastic bandage was used to make a circular protecting band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The band and the gauze patch were taken off and the residual test item was removed using water.
- Time after start of exposure: 4 hours
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 (beefy redness) to eschar formation preventing grading of erythema 4
Edema Formation
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 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritant / corrosive response data:
- During the reading which took place 1 hour after the end of the exposure, very slight erythema (barely perceptible) was stated on the skin in the site of the test item application in rabbit no. 1. During the readings which took place 24, 48 and 72 hours after the end of the exposure, no pathological changes were observed on the treated skin of the three rabbits.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as skin irritating.
- Executive summary:
The acute skin irritation/corrosion study, according to the OECD Guideline No. 404 / EU Method B.4., was performed in order to obtain information on health hazards likely to arise from skin contact with the test item. The study commenced with a sighting study on one animal. The test item (grounded to a powder) in the amount of 0.5 g was applied only once to the shaved skin of one animal and covered with a protecting band. The exposure lasted 4 hours. After the evaluation of the treated skin, the test item was applied to the skin of the next two rabbits for 4 hours. General clinical observations of all animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48 and 72 hours after the end of the exposure. The animals’ body weight was determined on the administration day (day 0) and on the last day of the experiment. During the reading which took place 1 hour after the end of the exposure, very slight erythema (barely perceptible) was stated on the skin in the site of the test item application in rabbit no. 1. During the readings which took place 24, 48 and 72 hours after the end of the exposure, no pathological changes were observed on the treated skin of the three rabbits.
Reference
Table 1: Dermal irritation scores
Erythema |
Oedema |
|||||
Animal No |
1 |
2 |
3 |
1 |
2 |
3 |
after 24 h |
0 |
0 |
0 |
0 |
0 |
0 |
after 48 h |
0 |
0 |
0 |
0 |
0 |
0 |
after 72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean score 24 – 72 h |
0 |
0 |
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 06 December 2012 to 04 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP 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 (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Institute of Occupational Medicine, Łódź
- Age at study initiation: The experiment was conducted on three females which were 5.5 months old.
- Weight at study initiation: 4.2-4.7 kg
- Housing: The animals were kept individually in metal cages with the following dimensions: 60 x 35 x 40 cm (length x width x height).
- Diet (e.g. ad libitum): LSK standard granulated laboratory fodder, ad libitum
- Water (e.g. ad libitum): drinking tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 30 – 65%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark
IN-LIFE DATES: From: 12 December 2012 To: 24 December 2012 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test item (grounded to a powder) in a volume of 0.1 mL (0.049 g) was administered to the conjunctival sac of one eye of the animal by gently pulling the lower eyelid away from the eyeball. - Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 7 days after the administration of the test item.
- Number of animals or in vitro replicates:
- Three females
- Details on study design:
- SCORING SYSTEM:
Cornea
Opacity: degree of density (readings should be taken from most dense area) *
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Maximum possible: 4 * The area of corneal opacity should be noted
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris reactive to light (a sluggish reaction is considered to be an effect 1
Hemorrhage, gross destruction, or no reaction to light 2
Maximum possible: 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Maximum possible: 3
Chemosis
Swelling (refers to lids and/or nictitating membranes)
Normal 0
Some swelling above normal 1
Obvious swelling, with partial eversion of lids 2
Swelling, with lids about half closed 3
Swelling, with lids more than half closed 4
Maximum possible: 4 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritant / corrosive response data:
- After the administration of the test item, some pathological changes were observed in the conjunctivas of the animals’ eyes. No pathological changes were stated in the cornea and iris.
During the reading which took place 1 hour after the administration of the test item, congestion of the nictitating membrane was observed in three animals. Moreover, erythema in the form of congestion (injection) of some blood vessels and circumcorneal injection were stated in animals no. 2 and 3. Swelling of the nictitating membrane was observed in animal no. 2.
During the reading which took place 24 hours after the administration of the test item, congestion of the nictitating membrane was observed in animals no. 2 and 3. Moreover, circumcorneal injection was stated in animal no. 2. No conjunctival edema was observed.
During the reading which took place 48 hours after the administration of the test item, congestion of the nictitating membrane was observed in animals no. 2 and 3.
During the reading which took place 72 hours after the administration of the test item, congestion of the nictitating membrane was observed in animal no. 2.
During the reading which took place 7 days after the administration of the test item, no pathological changes were observed in rabbit no. 2. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as eye irritating.
- Executive summary:
The acute eye irritation/corrosion study, according to the OECD Guideline No. 405 / EU Method B.5., was performed in order to obtain information on health hazards likely to arise from possible contact of the test item. The study started with a preliminary study on one animal. The test item was grounded to a powder and administered to the conjunctival sac of one eye of the animal (rabbit no. 1). Its volume was 0.1 mL. The second eye served as a control. After the evaluation of the treated eye, the test item was applied to the eyes of the next two animals (rabbit no. 2 and 3). General clinical observations of the animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations for changes in the cornea, iris and conjunctiva were performed 1, 24, 48 and 72 hours (all animals) as well as 7 days (rabbit no. 2) after the administration of the test item. The animals’ body weight was determined on the administration day (day 0) and on the last day of the experiment. After the administration of the test item, some pathological changes were observed in the conjunctivas of the animals’ eyes. No pathological changes were stated in the cornea and iris. Based on the available results, the test substance is not classified as eye irritating.
Reference
Table 1: Eye irritation scores
Animal |
Region of eye |
24 h |
48 h |
72 h |
7 d |
1 |
Cornea
|
0 |
0 |
0 |
- |
Iris
|
0 |
0 |
0 |
- |
|
Conjunctivae erythema |
0 |
0 |
0 |
- |
|
Conjunctivae swelling |
0 |
0 |
0 |
- |
|
2 |
Cornea
|
0 |
0 |
0 |
0 |
Iris
|
0 |
0 |
0 |
0 |
|
Conjunctivae erythema |
1 |
1 |
1 |
0 |
|
Conjunctivae swelling |
0 |
0 |
0 |
0 |
|
3 |
Cornea
|
0 |
0 |
0 |
- |
Iris
|
0 |
0 |
0 |
- |
|
Conjunctivae erythema |
1 |
1 |
0 |
- |
|
Conjunctivae swelling |
0 |
0 |
0 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Key study: Skin irritation. OECD guideline and EU method. GLP study.
Based on the available results, the test substance is not classified as skin irritating.
Key study: Eye irritation OECD guideline and EU method. GLP study.
Based on the available results, the test substance is not classified as eye irritating.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.
Justification for selection of eye irritation endpoint:
Only one study available. Klimisch 1 and the study was carried out in accordance with internationally valid GLP principles.
Justification for classification or non-classification
Based on the available data, the substance is not classified as skin or eye irritating.
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