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EC number: 245-423-3 | CAS number: 23089-26-1
- 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 of an OECD 404 study the test item is not requiring classification for skin irritation (UN GHS: No Category) (reference 7.3.1 -1).
Based on the results of an OECD 405 study the test item is not requiring classification for eye irritation (UN GHS: No Category) (reference 7.3.2 -1).
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:
- 03 October 1988 - 02 March 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Animal Breeder: Gaukler; D-6050 Offenfach/ Main, FRG
- Weight at study initiation: male 2.84 kg, females 3.0 kg
- Housing: individually in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: Kilba 341, 4 MM (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland); about 130 g/animal/day
- Water: tap water; about 250 mL/animal/day
- Acclimation period: at least 8 days before study start (same housing conditions as during the study).
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod (dark / light): 12 h /12 h - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- no vehicle
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied. 0.5 mL (to test patches, 2.5 x 2.5 cm) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 (2 females, 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap: porous dressing (four layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30 - 60 minutes after removal of the test patch and 24 h, 48 h, 72 h and 7 d after beginning of application
SCORING SYSTEM
Evaluation of erythema (R) and edema (ED):
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4= sevree to very severe
Calculation of the mean according to 83/467/EEC criteria of 29th 1983 (for calculation of the means of erythrema and eodema only the readings of 24, 48 and 72 hours are used). - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: only one animal showed a slight edema after 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions chosen, the test substance is considered not to be irritating to the skin.
- Executive summary:
A study according to OECD guideline 404 was designed to assess the skin irritation potential of the test item following a single dermal application to rabbits. Three rabbits each were administered a single dermal dose of 0.5 mL of the test substance and observed for 7 days. Slight erythrema were observed, which were fully rerversible within 7 days. One animal showed a very slight edema which was fully reversible within 48 hours. The mean erythrema and oedema scores were below the threshold for classification. The test substance is considered not to be irritating to the skin.
Reference
Table 1: Results
Readings | Animal | Erythema | Edema | Further findings |
4h | 1 | 1 | 0 | |
2 | 1 | 0 | ||
3 | 1 | 0 | ||
24h | 1 | 2 | 0 | |
2 | 1 | 0 | ||
3 | 2 | 1 | ||
48h | 1 | 1 | 0 | |
2 | 0 | 0 | ||
3 | 2 | 0 | ||
72h | 1 | 0 | 0 | scaling |
2 | 0 | 0 | ||
3 | 1 | 0 | scaling | |
7d | 1 | 0 | 0 | scaling |
2 | 0 | 0 | scaling | |
3 | 0 | 0 | scaling | |
Mean (24h-72h) | 1 | 1,0 | 0,0 | |
2 | 0,3 | 0,0 | ||
3 | 1,7 | 0,3 | ||
Mean (24h-72h) | all animals | 1,0 | 0,1 |
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:
- 03 October 1988 - 02 March 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Animal Breeder: Gaukler, D-6050 Offenbach/Main, FRG
- Mean weight at study initiation: males 3.59 kg, female 3.57 kg
- Housing: Idividually in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: about 130 g per animal per day of Kliba 341, 4 MM (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 8 days before study start (same housing conditions as during the study)
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod (dark / light): 12 h / 12 h - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 72 hours (substance was not washed out)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (two males, one female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was not washed out.
SCORING SYSTEM: According to OECD guideline OECD 405
- Readings: 1 h, 24 h, 48 h, 72 h after application - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions chosen, the test substance is considered not to be irritating to the eye.
- Executive summary:
A study according to OECD guideline 405 was designed to assess the eye irritation potential of the test item. 0.1 mL of test substance were applied undiluted to the conjunctival sac of the right eyelid of 3 rabbits. The untreated eyes of the same animals served as control. The substance was not washed out and the reaction to the eyes was observed 1, 24, 48 and 72 hours after application. Mean erythrema, edama and chemosis scores at 24/48/72 h were 0.0 and the mean conjunctivae score was 1.2. This observed effect was reversible within 72 hours. The test substance is considered not to be irritating to the eye.
Reference
Table 1: Results
Cornea | Iris | Conjunctiva | ||||
Readings | Animal | Opacity | Redness | Swelling | Further findings | |
1h | 1 | 0 | 0 | 2 | 0 | |
2 | 0 | 0 | 2 | 0 | ||
3 | 0 | 0 | 2 | 0 | ||
24h | 1 | 0 | 0 | 2 | 0 | |
2 | 0 | 0 | 2 | 0 | ||
3 | 0 | 0 | 2 | 0 | ||
48h | 1 | 0 | 0 | 1 | 0 | |
2 | 0 | 0 | 2 | 0 | ||
3 | 0 | 0 | 2 | 0 | ||
72h | 1 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | ||
Mean (24h-72h) | 1 | 0.0 | 0.0 | 1.0 | 0.0 | |
2 | 0.0 | 0.0 | 1.3 | 0.0 | ||
3 | 0.0 | 0.0 | 1.3 | 0.0 | ||
Mean (24h-72h) | all animals | 0.0 | 0.0 | 1.2 | 0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
OECD 404 (reference 7.3.1-1)
A study according to OECD guideline 404 was designed to assess the skin irritation potential of the test item following a single dermal application to rabbits. Three rabbits were each administered a single dermal dose of 0.5 mL of the test substance and observed for 7 days. Slight erythrema were observed, which were fully rerversible within 7 days. One animal showed a very slight edema which was fully reversible within 48 hours. The mean erythrema and oedema scores were below the threshold for classification. The test substance is considered not to be irritating to the skin.
Pretest for OECD 406 (reference 7.4.1 -1)
As a pretest for a sensitisation study (Buehler Test) in accordance with OECD Guideline 406 the skin irritation potential of the (+/-)-α-Bisabolol (source substance) was assed using 7 female guinea pigs. The test item was tested undiluted and diluted (concentration: 25%, 50% and 75%). Lutrol E 400 DAB was used as vehicle. Patches containing 0.5 mL of the test substance or test substance formulations were applied to the skin of the flanks under an occlusive dressing. The exposure duration was 6 hours. 6 hours and 30 hours after beginning of the application the skin reaction was scored. Only one animal showed discrete or patchy erythema after application of the diluted test item (75%). All other animals showed no visible changes. Therefore, the test substance is considered not to be irritating to the skin.
(+/-)-α-Bisabolol (source substance) is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance).
Eye irritation
OECD 405 (reference 7.3.2-1)
A study according to OECD guideline 405 was designed to assess the eye irritation potential of the test item. 0.1 mL of test substance were applied undiluted to the conjunctival sac of the right eyelid of 3 rabbits. The untreated eyes of the same animals served as control. The substance was not washed out and the reaction to the eyes was observed 1, 24, 48 and 72 hours after application. Mean erythrema, edama and chemosis scores at 24/48/72 h were 0.0 and the mean conjunctivae score was 1.2. This observed effect was reversible within 72 hours. The test substance is considered not to be irritating to the eye.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered to be classified for skin irritation and eye damaging potential under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.
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