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EC number: 279-632-6 | CAS number: 80939-62-4
- 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
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- 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 potential of test substance to cause acute dermal irritation was evaluated in two studies. The potential of the test substance to cause damage to the conjunctiva, iris or cornea was evaluated in one study. The test substance showed a skin and eye irritation potential under the test conditions chosen.
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:
- November 23, 1981 - December 7, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with restrictions (study was performed under QAU): - occlusive conditions - exposure period of 24 hours
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive conditions, exposure period of 24 hours)
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Diet (ad libitum): standard rabbit food - NAFAG, No. 814
- Water (ad libitum): drinking water
- Acclimation period: min. of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved (one flank), shaved and scarified (other flank)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 male ande 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: both side flanks (one side was just shaved, the other one was shaved and scarified)
- Type of wrap if used: gauze patch (2.5x2.5 cm), patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
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
Total possible erythema score: 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
Total possible edema score: 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h- 48 h - 72 h
- Score:
- 2.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days (all animals were affected)
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days (all animals were affected)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 5
- Max. score:
- 8
- Remarks on result:
- other: The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4 (FHSLA § 191.11): The test substance caused a marked irritation when applied to intact and abraded rabbit skin.
- Irritant / corrosive response data:
- The following observations were made in practically all the application sites in the course of the experiment, in addition to the scores: erythema greater than the surface of compound patch, ischaemic areas, cracked skin, scales formation.
- Other effects:
- Besides transient periods of anorexia in few animals no other symptoms were observed. One female animal died at day 8 of test independently of the compound administration. No gross lesions were found.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present experiment the test article was found to cause a marked irritation when applied to intact and abraded rabbit skin.
Reference
In the following tables, only the results of the treatment of the intact skin side is given, as testing on intact skin is recommended by OECD guideline 404 and the basis for skin irritation assessment.
Table 1: Evaluation of erythema an edema in male animals after a 24 hours treatment under occlusive conditions:
Observation time |
Animal |
Erythema |
Edema |
24 hours |
1 |
3 |
3 |
|
2 |
2 |
2 |
|
3 |
3 |
3 |
48 hours |
1 |
3 |
3 |
|
2 |
3 |
2 |
|
3 |
3 |
3 |
72 hours |
1 |
4 |
4 |
|
2 |
3 |
2 |
|
3 |
4 |
3 |
14 days |
1 |
4 |
4 |
|
2 |
3 |
2 |
|
3 |
4 |
3 |
Mean (24-48-72h) |
1 |
3.33 |
3.33 |
|
2 |
2.66 |
2 |
|
3 |
3.33 |
3 |
Mean |
|
3.11 |
2.78 |
Table 2: Evaluation of erythema an edema in female animals after a 24 hours treatment under occlusive conditions:
Observation time |
Animal |
Erythema |
Edema |
24 hours |
1 |
2 |
2 |
|
2 |
2 |
2 |
|
3 |
3 |
2 |
48 hours |
1 |
2 |
2 |
|
2 |
3 |
3 |
|
3 |
3 |
2 |
72 hours |
1 |
2 |
2 |
|
2 |
3 |
3 |
|
3 |
3 |
2 |
14 days |
1 |
dead |
dead |
|
2 |
4 |
3 |
|
3 |
4 |
3 |
Mean (24-48-72h) |
1 |
2 |
2 |
|
2 |
2.66 |
2.66 |
|
3 |
3 |
2 |
Mean |
|
2.55 |
2.22 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- November 23, 1981 - December 7, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with restrictions: - observation period of 14 days, but reversibility of the effects was not completed - no detailed information of the test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (observation period of 14 days, but reversibility of the effects was not completed, no detailed information of the test substance)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Diet (ad libitum): standard rabbit food - NAFAG, No. 814
- Water (ad libitum): drinking water
- Acclimation period: min. of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye was not treated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single treatment of all animals; in 3 of the 9 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 9 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
SCORING SYSTEM: as described in OECD Guideline 405
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 -72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 -48 -72 h
- Score:
- 2.28
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days (in 2 of 5 animals)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days (in 3 of 5 animals)
- Other effects:
- Besides a transient anorexia of one animal on day 11, no symptoms were observed.
One female animal died on day 8 independently of the compound administration.
Besides spotted lungs no gross lesion were found. - Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this experiment the test material was found to cause irritation when applied to the rabbit eye mucosa.
Reference
Table 1: Rabbit eye irritation scores after single treatment with the test substance (m=males, f=females), here the results of the treated eyes, that were not rinsed, are given:
Observation time |
Animal |
Cornea |
Iris |
Conjuctiva |
|||
|
|
OP |
AR |
|
RED |
SW |
DI |
24 H |
1 (m) |
0 |
0 |
0 |
2 |
1 |
0 |
|
2 (m) |
1 |
4 |
0 |
3 |
3 |
1 |
|
3 (m) |
1 |
1 |
0 |
2 |
2 |
2 |
|
4 (f) |
1 |
3 |
0 |
2 |
2 |
1 |
|
5 (f) |
0 |
0 |
0 |
2 |
2 |
1 |
|
6 (f) |
1 |
2 |
0 |
2 |
3 |
2 |
48 H |
1 (m) |
0 |
0 |
0 |
2 |
1 |
0 |
|
2 (m) |
1 |
3 |
0 |
3 |
2 |
1 |
|
3 (m) |
0 |
0 |
0 |
2 |
1 |
1 |
|
4 (f) |
1 |
1 |
0 |
2 |
2 |
1 |
|
5 (f) |
0 |
0 |
0 |
2 |
2 |
1 |
|
6 (f) |
2 |
2 |
0 |
3 |
3 |
2 |
72 H |
1 (m) |
0 |
0 |
0 |
2 |
2 |
0 |
|
2 (m) |
1 |
1 |
0 |
2 |
2 |
1 |
|
3 (m) |
0 |
0 |
0 |
2 |
2 |
0 |
|
4 (f) |
1 |
1 |
0 |
3 |
3 |
2 |
|
5 (f) |
0 |
0 |
0 |
2 |
2 |
0 |
|
6 (f) |
2 |
2 |
0 |
3 |
3 |
2 |
7 days |
1 (m) |
0 |
0 |
0 |
1 |
2 |
0 |
|
2 (m) |
0 |
0 |
0 |
2 |
2 |
0 |
|
3 (m) |
0 |
0 |
0 |
1 |
1 |
0 |
|
4 (f) |
0 |
0 |
0 |
2 |
2 |
0 |
|
5 (f) |
0 |
0 |
0 |
1 |
2 |
1 |
|
6 (f) |
1 |
1 |
0 |
2 |
2 |
1 |
14 days |
1 (m) |
0 |
0 |
0 |
1 |
1 |
4 |
|
2 (m) |
0 |
0 |
0 |
0 |
1 |
2 |
|
3 (m) |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 (f) |
- |
- |
- |
- |
- |
- |
|
5 (f) |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 (f) |
0 |
0 |
0 |
1 |
1 |
4 |
Mean (24-48-72 h) |
1 (m) |
0.00 |
0.00 |
0.00 |
2.00 |
1.33 |
0.00 |
|
2 (m) |
1.00 |
2.67 |
0.00 |
2.67 |
2.33 |
1.00 |
|
3 (m) |
0.33 |
0.33 |
0.00 |
2.00 |
1.67 |
1.00 |
|
4 (f) |
1.00 |
1.67 |
0.00 |
2.33 |
2.33 |
1.33 |
|
5 (f) |
0.00 |
0.00 |
0.00 |
2.00 |
2.00 |
0.67 |
|
6 (f) |
1.67 |
2.00 |
0.00 |
2.67 |
3.00 |
2.00 |
Mean |
|
0.67 |
1.11 |
0.00 |
2.28 |
2.11 |
1.00 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Two studies are avaible, that investigated the skin irritationg potential of the test substance.
In the first available study, the potential of the test substance to cause acute dermal irritation or corrosion was assessed by single topical application of an amount of 0.5 ml of the unchanged test substance for 24 hours to the intact skin of 3 male and 3 female White New Zealand rabbits using a gauze patch of 2.5 x 2.5 cm, covered with an impermeable material and fastened to the body of the animals with adhesive tape. The cutaneous reactions were assessed 24, 48 and 72 hours after removal of the patch.
Erythema greater than the surface of compound patch, ischaemic areas, cracked skin, scales formation and transient periods of anorexia in few animals was observed in the animals during the course of the study. One female animal died at day 8 of test independently of the compound administration. Mean 24-48-72-hour scores were 2.83 and 2.5 for erythema and edema, respectively (intact skin sites). The effects were not fully reversible within 14 days in all animals. The test was also conducted on the abraded skin.
In the second available study, the potential of the test substance to cause acute dermal irritation or corrosion was assessed by single topical application of an amount of 0.5 ml of the test substance (1 % solution; vehicle was undefined) for 24 hours to the intact skin of 3 male and 3 female White New Zealand rabbits using a gauze patch of 2.5 x 2.5 cm, covered with an impermeable material and fastened to the body of the animals with adhesive tape. The cutaneous reactions were assessed 24, 48 and 72 hours after removal of the patch. Under the conditions of this study, an erythema score of 0.58 and an edema score of 0.1 was found based on the mean values of 6 animals at 24/48/72 hours (intact skin). The effects were fully reversible within 7 days in all animals. The test was also conducted on the abraded skin.
Taking these two studies into consideration, the findings after 24 hours occluded application with the unchanged test substance were used for evaluation. The conclusion may be more stringent than one dervied from a 4 h semi-occluded application required by the current OECD guideline. Therefore, the test substance has to be classfied as skin irritant.
Eye Irritation
In this study, the potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 ml bulk volume of the test substance to one eye of each 6 male and 3 female White New Zealand rabbits (in 3 males of the overall 9 rabbits, approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline). The ocular reactions were assessed approximately 24, 48 and 72 hours after application.
One female animal died on day 8 independently of the compound administration. Mean 24-48-72-hour scores for the 6 animals (eyes were not washed out) were 0.67, 0.00, 2.28 and 2.11 for corneal opacity, iris lesions, redness of the conjunctiva and chemosis. Effects on the cornea were fully reversible within 14 days, effects on the conjunctivae and chemosis were not fully reversible within 14 days in 2 and 3 animals of 5, respectively, but with a clear tendency of reversibility. Overall, the test substance does show an eye irritation potential under the test conditions chosen.
Respiratory irritation
No data available
Justification for selection of skin irritation / corrosion endpoint:
Study performed similar to guideline under quality control
Justification for selection of eye irritation endpoint:
Study performed similar to guideline under quality control
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC.
Based on the data, the test subtance has to be classified as skin irritant (Xi, R38) and as irritating to the eyes (Xi, R36).
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, the test subtance has to be classified as skin irritant (Cat. 2) and as irritating to the eyes (Cat. 2).
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