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EC number: 219-969-8 | CAS number: 2587-76-0
- 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
Non irritating, rabbit (male/female), Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US AFDO, Sachsse (1973)
Eye
Non irritating, rabbit, (male/female), Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US AFDO, Sachsse (1973)
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:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study conducted in 1973, prior to inception of GLP
- Specific details on test material used for the study:
- - Physical form of test material: Not reported; the report implies that it is a liquid.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: Kept separately
- Diet: ad libitum
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and slightly scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- The test material was applied to each site (intact and slightly scarified) in quantities of 0.5 mL.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six rabbits (3 males/3 females)
- Details on study design:
- TEST SITE
- Pre-treatment: The rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment.
- Area of exposure: 2.5 x 2.5 cm gauze pads were soaked with the test material and applied to the skin.
- Type of wrap if used: The gauze patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: The gauze patches were removed 24 hours after application.
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 slight eschar formation (injuries in depth): 4
- Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising: 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: Mean of 24 and 72 hour time points
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: Mean of 24 and 72 hour time points
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: Mean of 24 and 72 hour time points
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: Mean of 24 and 72 hour time points
- Score:
- 0.25
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Scarified skin
- Irritant / corrosive response data:
- Signs of erythema were observed on both the intact and abraded skin of 4 animals at the 24 hour observation; all reactions were scored as 1. All signs were fully reversible by the 72 hour observation. The remaining two animals exhibited no signs of erythema.
Signs of oedema were observed on both the intact and abraded skin of 2 animals at the 24 hour observation; three of the reactions were scored as 1 and the scarified skin site of one rabbit was scored as a 2. All signs were fully reversible by the 72 hour observation. The remaining four animals exhibited no signs of oedema. - Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was determined not to be a skin irritant to rabbits.
- Executive summary:
The irritation/corrosion potential of the test material was investigated following the patch-test technique described in the “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics” (1959) of the US Association of Food and Drug Officials (AFDO).
Six rabbits (3 male/3 female) of the New Zealand White strain were shaved on the whole back and flanks two days prior to treatment; the left side was slightly scarified immediately before treatment. A gauze patch soaked with the 0.5 mL of the test material was immediately applied to the prepared skin (both shaved and scarified sites). The patch was covered with a plastic film which was fixed to the body with adhesive tape. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after application.
Signs of erythema were observed on both the intact and abraded skin of 4 animals at the 24 hour observation; all reactions were scored as 1. All signs were fully reversible by the 72 hour observation. The remaining two animals exhibited no signs of erythema.
Signs of oedema were observed on both the intact and abraded skin of 2 animals at the 24 hour observation; three of the reactions were scored as 1 and the scarified skin site of one rabbit was scored as a 2. All signs were fully reversible by the 72 hour observation. The remaining four animals exhibited no signs of oedema.
Under the conditions of this study, the test material was determined not to be a skin irritant to rabbits.
Reference
Table 1: Evaluation of Skin Reactions
Animal No. and Sex |
Skin Reaction |
24 hours after application |
72 hours after application |
|||
Intact Skin |
Scarified Skin |
Intact Skin |
Scarified Skin |
|||
1 |
M |
Erythema |
1 |
1 |
0 |
0 |
Oedema |
1 |
2 |
0 |
0 |
||
2 |
M |
Erythema |
1 |
1 |
0 |
0 |
Oedema |
1 |
1 |
0 |
0 |
||
3 |
M |
Erythema |
0 |
0 |
0 |
0 |
Odema |
0 |
0 |
0 |
0 |
||
4 |
F |
Erythema |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
||
5 |
F |
Erythema |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
||
6 |
F |
Erythema |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
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:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study conducted in 1973, prior to inception of GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Kept separately
- Diet: ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The test material was introduced into the conjunctival sac of the left eye with a syringe. After application, the eyelids were held open for a few seconds.
- Observation period (in vivo):
- 24 hours and 2, 3, 4 and 7 days post instillation.
- Number of animals or in vitro replicates:
- Six rabbits (3 male/3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water.
- Time after start of exposure: About 30 seconds after treatment.
TOOL USED TO ASSESS SCORE: hand-slit lamp
SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense is taken for reading)
0: No ulceration or opacity
1: Scattered or diffuse areas of opacity, details of iris clearly visible
2: Easily discernible translucent areas, details of iris slightly obscured
3: Opalescent areas, no details of iris visible, size of pupil barely discernible
4: Opaque cornea, iris not discernible through the opacity
IRIS
0: Normal
1: Folds above normal, congestion, swelling, circumcorneal injection (any of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2: No reaction to light, haemorrhage, gross destruction (any or all of all these)
CONJUNCTIVAE
- Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae excluding cornea and iris)
0: Blood vessels normal
1 Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red
- Chemosis: lids and/or nictating membranes.
0: No swelling
1: Any swelling above normal (includes nictating membranes)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids about half closed to completely closed
DISCHARGE
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs a considerable area around the eye - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- other: combined redness, chemosis and discharge scores
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Eyes rinsed. The redness, chemosis and discharge scores were reported as one combined figure; it was not possible to assign a value to each of the individual parameters.
- Irritation parameter:
- other: combined redness, chemosis and discharge scores
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1.33
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Eyes not rinsed. The redness, chemosis and discharge scores were reported as one combined figure; it was not possible to assign a value to each of the individual parameters.
- Irritant / corrosive response data:
- No corneal or iridial effects were observed in any rabbit at any time point.
Day 1 after application of the test material, five out of the six rabbits (3 with rinsed eyes and 2 with not rinsed eyes) demonstrated signs of eye irritation (redness, chemosis and discharge); one score was reported for each animal for the three parameters. The maximum combined score was 5.
On Day 2, the signs of irritation in four animals were completely resolved. The remaining animal still exhibiting signs of irritation (eyes not rinsed) received a combined score of 3 for redness, chemosis and discharge. These signs were completely resolved by 72 hours post installation of the test material. - Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was determined not to be an eye irritant to rabbits.
- Executive summary:
The potential of the test material to cause eye irritation or corrosion was investigated following the technique described in the “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics” (1959) of the US Association of Food and Drug Officials (AFDO).
The test material (0.1 mL) was administered into the left eye of 6 New Zealand White rabbits (3 male/3 female). The right eye remained untreated and served as a control. The eyes of the female rabbits were rinsed approximately 30 seconds after administration with lukewarm water.
The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
No corneal or iridial effects were observed in any rabbit at any time point. Day 1 after application of the test material, five out of the six rabbits (3 with rinsed eyes and 2 with not rinsed eyes) demonstrated signs of eye irritation (redness, chemosis and discharge). On day 2, the signs of irritation in four animals were completely resolved. One remaining animal still exhibited signs of irritation (eyes not rinsed); these signs were completely resolved by 72 hours post installation of the test material.
Under the conditions of this study, the test material was determined not to be an eye irritant to rabbits.
Reference
Table 1: Summary of Individual Scores
Eyes rinsed |
Eyes not rinsed |
|||||||||||||||||
Days after Application |
Rabbit 1 (F) |
Rabbit 2 (F) |
Rabbit 3 (F) |
Rabbit 4 (M) |
Rabbit 5 (M) |
Rabbit 6 (M) |
||||||||||||
Cornea |
Iris |
Conjunct. |
Cornea |
Iris |
Conjunct. |
Cornea |
Iris |
Conjunct. |
Cornea |
Iris |
Conjunct. |
Cornea |
Iris |
Conjunct. |
Cornea |
Iris |
Conjunct. |
|
1 |
0 |
0 |
3 |
0 |
0 |
5 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
4 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunct. = The combined score for redness, chemosis and discharge.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
The irritation/corrosion potential of the test material was investigated following the patch-test technique described in the “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics” (1959) of the US Association of Food and Drug Officials (AFDO). The study was assigned a reliability score of 2 in accordance with the principles for assessing data quality set forth by Klimisch et al. (1997).
Six rabbits (3 male/3 female) of the New Zealand White strain were shaved on the whole back and flanks two days prior to treatment; the left side was slightly scarified immediately before treatment. A gauze patch soaked with the 0.5 mL of the test material was immediately applied to the prepared skin (both shaved and scarified sites). The patch was covered with a plastic film which was fixed to the body with adhesive tape. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after application.
Signs of erythema were observed on both the intact and abraded skin of 4 animals at the 24 hour observation; all reactions were scored as 1. All signs were fully reversible by the 72 hour observation. The remaining two animals exhibited no signs of erythema.
Signs of oedema were observed on both the intact and abraded skin of 2 animals at the 24 hour observation; three of the reactions were scored as 1 and the scarified skin site of one rabbit was scored as a 2. All signs were fully reversible by the 72 hour observation. The remaining four animals exhibited no signs of oedema.
Under the conditions of this study, the test material was determined not to be a skin irritant to rabbits.
Eye Irritation
The potential of the test material to cause eye irritation or corrosion was investigated following the technique described in the “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics” (1959) of the US Association of Food and Drug Officials (AFDO). The study was assigned a reliability score of 2 in accordance with the principles for assessing data quality set forth by Klimisch et al. (1997).
The test material (0.1 mL) was administered into the left eye of 6 New Zealand White rabbits (3 male/3 female). The right eye remained untreated and served as a control. The eyes of the female rabbits were rinsed approximately 30 seconds after administration with lukewarm water.
The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
No corneal or iridial effects were observed in any rabbit at any time point. Day 1 after application of the test material, five out of the six rabbits (3 with rinsed eyes and 2 with not rinsed eyes) demonstrated signs of eye irritation (redness, chemosis and discharge). On day 2, the signs of irritation in four animals were completely resolved. One remaining animal still exhibited signs of irritation (eyes not rinsed); these signs were completely resolved by 72 hours post installation of the test material.
Under the conditions of this study, the test material was determined not to be an eye irritant to rabbits.
Justification for classification or non-classification
With regard to the available study data, in accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to skin irritation/corrosion or eye irritation.
In accordance with Annex VI, Regulation (EC) No. 1272/2008, the substance requires classification with respect to skin irritation as Category 2 (H315: Causes skin irritation) and eye irritation as Category 2 (H319: Causes serious eye irritation).
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