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EC number: - | CAS number: -
- 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: No adverse effect observed (not irritating). The substance is classified as "not irritating" to rabbit skin.
Eye irritation: No adverse effect observed (not irritating). The substance is classified as "not irritating" to the eye.
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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D - 88397 Biberach / Riss, Germany
- Age at study initiation: 15-17 weeks
- Weight at study initiation: 2.8-3.1 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1996-08-07 To: 1996-08-15 - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72h
- Number of animals:
- 1 male, 2 female animals
- Details on study design:
- TEST SITE
- Area of exposure: back
- coverage: approx. 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water
- Time after start of exposure: 4h
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
Maximum possible 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
Maximum possible score 4
Maximum cumulative score: 8 - Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The substance showed a primary irritation score of 0.00, when applied to healthy intact rabbit skin.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed.
Light orange staining by the test article of the treated skin was observed.
The body weight gain of all rabbits was within the normal range of variability. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is classified as "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test article was investigated by Directive 92/69 EEC, B.4. "Acute Toxicity - Skin Irritation", July 31, 1992, U.S. Environmental Protection Agency, Code of Federal Regulations 40, Part 798, Health Effects Testing Guidelines, Subpart E, Specific organ/tissue toxicity, Paragraph 798.4470 "Primary dermal irritation", revised as of July 1, 1993, and OECD Guidelines for Testing of Chemicals, Section 4, number 404, "Acute Dermal Irritation / Corrosion", adopted July 17, 1992 (reported Paris April 29, 1993).
500 mg of the test item were topically applied onto 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of
figures. Under the conditions of this experiment, the substance was found to cause a primary irritation score of 0.00 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. The test article caused light orange staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval.
Based upon the referred classification criteria , the substance is classified as "not irritating" to rabbit skin.
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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D - 88397 Biberach / Riss, Germany
- Age at study initiation: 15-17 weeks
- Weight at study initiation: 2.8-3.1 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1996-08-14 To: 1996-08-22 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Single treatment with the test item.
- Observation period (in vivo):
- Observation at 1, 24, 48, and 72h after instillation of the test item into the eye.
- Number of animals or in vitro replicates:
- Three animals (1 male, 2 females)
- Details on study design:
- SCORING SYSTEM: Standard Draize system
Corneal irritation: 0-4
Iris irritation: 0-2
Conjunctival redness: 0-3
Chemosis: 0-4
REMOVAL OF TEST SUBSTANCE
- Washing: not performed - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: conjunctiae redness (score = 2) was observed only at hour 1, but was zero after 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: chemosis observed (max. score = 1) was observed only at hour 1, but was zero after 24 hours
- Irritant / corrosive response data:
- The substance showed a primary irritation score of 0.00, when applied to the conjunctival sac of the rabbit eye.
After one hour, moderate reddening of the conjunctivae and slight watery discharge were noted in all animals, and slight swelling was noted in two of three animals. All signs of irritation were reversible after 24 hours.
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- - No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
- Light orange staining of the sclera was seen in all animals after one hour. Light orange staining of the conjunctivae was noted after one and 24 hours in two of three animals.
- The body weight of the animals was within the normal range of variability. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria, the substance is classified as "not irritating" to the eye.
- Executive summary:
The primary irritation potential of the substance was investigated according to Directive 92/69 EEC, B.5. "Acute Toxicity - Eye Irritation", July 31, 1992, U. S. Environmental Protection Agency, Code of Federal Regulations 40, Part 798, Health Effects Testing Guidelines, Subpart E, Specific organ/tissue toxicity, Paragraph 798.4500 "Primary eye irritation", revised as of July 1, 1993, and OECD Guidelines for Testing of Chemicals, Section 4, number 405 "Acute Eye Irritation / Corrosion", adopted February 24, 1987.
0.1 g of the test item was instilled undiluted into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures.
The primary irritation score was 0.00 (max. 13). After one hour, reddening of the conjunctivae and watery discharge were noted in all animals, and swelling was noted in two of three animals. All signs of irritation were reversible after 24 hours. Light orange staining of the sclera was seen in all animals after one hour. Light orange staining of the conjunctivae was noted after one and 24 hours in two of three animals.
No corrosion was observed at any of the measuring intervals.
Based upon the referred classification criteria, the substance is classified as "not irritating" to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two valid in-vivo studies on skin and eye iritation have been conducted with the registration substance. In order to assess the skin irritating potential of the test substance, 500 mg of the test item were topically applied onto 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test article caused light orange staining of the treated skin. Under the conditions of this experiment, the substance was found to cause a primary irritation score of 0.00 when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effects were noted on the treated skin of any animal at any measuring interval.
In order to assess the primary eye irritating potential of the test substance, 0.1 g of the test item was instilled undiluted into one eye of each of three young adult New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The primary irritation score was 0.00. After one hour, reddening of the conjunctivae and watery discharge were noted in all animals, and swelling was noted in two of three animals. All signs of irritation were reversible after 24 hours. Light orange staining of the sclera was seen in all animals after one hour. Light orange staining of the conjunctivae was noted after one and 24 hours in two of three animals. No corrosion was observed at any of the measuring intervals.
Justification for selection of skin irritation / corrosion endpoint:
The selected study was performed under GLP and in accordance with OECD TG 404. No other studies are available.
Justification for selection of eye irritation endpoint:
The selected study was performed under GLP and in accordance with OECD TG 405. No other studies are available.
Justification for classification or non-classification
Skin irritation: No adverse effect observed (not irritating). The substance is classified as "not irritating" to rabbit skin.
Eye irritation: No adverse effect observed (not irritating). The substance is classified as "not irritating" to the eye.
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.
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