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EC number: 201-327-3 | CAS number: 81-13-0
- 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
Based on the results obtained from testing the substance was considered not irritating to skin and eyes.
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:
- 1990-11-5 to 1990-11-8
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same 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
- Species:
- rabbit
- Strain:
- other: New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: male : 14 weeks, females: 15 weeks
- Weight at study initiation: male : 2.2 kg, females: 2.7 - 2.9 kg
- Housing:
- Diet: Pelleted standard Kliba 341, Batch 56/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g creme formulation containing 5 % (w/w) Panthenol - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 ( 1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 6cm²
- Coverage: 3 cm x 3 cm surgical gauze, covered by semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
OECD/GHS - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- no. 90; male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- no. 91; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- no. 92; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- no. 90; male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- no. 91; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- no. 92; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Clinical signs and viability/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
- Irritation: The test item showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
- Corrosion: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
- Body weights: With the exception of female no. 92 which showed slight loss of weight during acclimatization the body weight gain of all rabbits was similar. - Other effects:
- None.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No irrtation/corrosive effect occurred on the skin of any animal at measuring interval.
- Executive summary:
The test item was investigated for primary skin irritation in a study with rabbits in a 4-hour semi-occlusive application according to OECD guideline 404 and EU method B.4. The test article was applied undiluted in a dose of 0.5 g to the clipped dorsal skin of one male and two female New Zealand White rabbits. The exposure duration was 4 hours under a semi-occlusive wrapping. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the numerical scoring system according to the guidelines. The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effect occurred on the skin of any animal at measuring interval.
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:
- 1990-11-20 to 1990-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fuellinsdorf
- Age at study initiation: male : 12 weeks, females: 12 weeks
- Weight at study initiation: male : 2.4 kg, females: 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, Batch 56/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland) ad libitum
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 40-70 %
- Air changes (per hr): 10-15
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g creme formulation containing 5 % (w/w) Panthenol - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : No
SCORING SYSTEM:
OECD/GHS - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- no. 96; male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- no. 97; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- no. 98; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- no. 96; male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- no. 97; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- no. 98; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- no. 96; male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- no. 97; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- no. 98; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- no. 96; male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- no. 97; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- no. 98; female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- None.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No Irritation/corrosion was observed at any of the measuring intervals.
- Executive summary:
The test item was investigated for eye irritation/corrosion properties with three New Zealand White rabbits in a GLP and guideline study according to OECD guideline 405/EU method B.5. When administered neat into the conjunctival sac of the rabbit eye, the test item caused conjunctival injection disappearing within 24 hours. This reaction was characterized by a primary irritation score of 0.25, which indicates that the test article can be classified as non irritating for the rabbit eye. Based on this experimental result it can be assumed that short-lasting occasional or accidental contamination of the human eye with the substance will not be accompanied by risk for human health.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Irritation / corrosion
Based on the results obtained in the key study, a creme formulation containing 5 % of the test item was found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean values from 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effect occurred on the skin of any animal at measuring interval. In a supporting study application of the undiluted test substance to the skin of the back and ear of White Vienna rabbits under occlusion produced signs of irritation only after prolonged exposure. Based on the results of these tests, the substance has to be classified as not irritating to the skin.
Eye irritation
When administered neat into the conjunctival sac of the rabbit eye, a creme formulation containing 5 % of the test item caused conjunctival injection disappearing within 24 hours. This reaction was characterized by a primary irritation score of 0.25, which indicates that the test article can be classified as non irritating for the rabbit eye. Based on this experimental result it can be assumed that short-lasting occasional or accidental contamination of the human eye with the substance will not be accompanied by risk for human health. In a supporting study fifty microlitres of the undiluted test substance were instilled into one eye of each of 2 rabbits. For control purpose, pysiological saline was instilled into the other eye. The eyes were not washed. Animals were observed for 8 days. Slight irritation of the cornea was observed. The eyes were normal after 2 days.
Based on these results, the test substance was not irritating to the eyes.
Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline study.
Justification for selection of eye irritation endpoint:
GLP and guideline study.
Justification for classification or non-classification
Based on the results obtained from testing the substance was not classified and labeled acoording to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD).
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