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EC number: 812-962-6 | CAS number: 34354-88-6
- 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 / corrosion
1. Key study according to OECD Guideline No. 404 (May 12, 1981) and EEC Directive 84/449/EEC, Part B.4 (September 1984), GLP, Reliability 1. Result: not irritating to skin.
2. Supporting subacute 14 -day study, GLP, Reliability 4. Result: not irritating to skin.
3. Supporting study, human patch test (described in section 7.10.5): no adverse reactions observed; not irritating to skin.
Eye irritation
1. Key study according to OECD guideline No. 405 (February 24, 1987) and EEC Directive 92/69 /EEC, B.5 (December 1992), GLP, Reliability 1. Result: 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:
- 1992-01-28 to 1992-01-31
- 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:
- May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- September 1984
- GLP compliance:
- yes
- Specific details on test material used for the study:
- The test substance was determined not to be miscible with water and static.
The test substance was ground to a powder using a mortar and pestle.
To ensure close contact to the animal’s skin, the powdery test substance was applied using a patch, which was moistened with distilled water immediately before use. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Rabbit, New Zealand White, (SPF-Quality)
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 13 weeks
- Weight at study initiation: 2311-2833 grams
- Housing: conventionally, singly in stainless steel cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- diet: ad libitum, standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water: ad libitum, tap-water diluted with decalcified water
- Acclimation period: at least 5 days before start of treatment under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- no vehicle; test substance was applied using a moistened patch
NEGATIVE CONTROL
- The contralateral flank was similarly prepared, but without test substance
. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 50 min, 24 h, 48 h and 72 h after removal of the dressings and test substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: 100 %. Due to the physical properties of the test substance the amount of 0.5 g could not be dosed completely within the area that was covered by the patch (6 cm²) and a small amount was applied outside this area.
- Type of wrap if used: moistened Scotchpak-non-woven patch (2x3 cm, 3M, St. Paul, U.S.) mounted on Micropore tape (3M, St. Paul, U.S.). The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.)
REMOVAL OF TEST SUBSTANCE
- the remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: the test results were evaluated according to OECD guideline No. 404, “Acute Dermal Irritation/Corrosion”, adopted 28 July 2015.
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1,#2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 50 min
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 50 min
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No other effects reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance did not cause any irritation and thus, classification is not required.
- Executive summary:
In this skin irritation / corrosion study according to OECD Guideline No. 404 (May 12, 1981) and EEC Directive 84/449/EEC, Part B.4 (September 1984), 0.5 g of Ceramide III was applied onto shaved skin of three New Zealand White male albino rabbits using semi-occlusive dressings for 4 hours. An adjacent area of untreated skin, similarly prepared but without test substance and vehicle served as control area.
After 4 hours, Ceramide III was removed using tissue moistened with tap-water. Observations were made after 50 minutes, 24, 48, and 72 h after patch removal.
No reactions were seen; mean erythema and oedema scores after 24, 48, and 72 h were 0 in all animals.
Based on the results of this test, Ceramide III is not irritating to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- unknown
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Application of test substance for 4 hours using a semi-occlusive dressing. Administrations were repeated on each week-day during two consecutive weeks (a total of ten applications).
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: aapprox. 8 weeks
- Weight at study initiation: 1384-1517 grams
- Housing: conventionally, singly in stainless steel cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- iet: ad libitum, standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day. In addition, hay (BMI Helmond, The Netherlands) was provided once a week.
- Water: ad libitum, tap-water diluted with decalcified water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: propylene glycol
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams of the test substance was mixed with 0.8 ml of propylene glycol, except for one occasion. On day 1, one animal received 0.5 grams mixed with 0.5 ml of propylene glycol. However, this ratio was considered not adequate.
0.5 gram of the moistened test substance was applied to the intact skin of the shaved area. - Duration of treatment / exposure:
- 4 hours for each treatment
The treatment was repeated on the same application sites for two periods of 5 consecutive days (a total of ten applications) The animals received no treatment on two days in between the two treatment periods. - Observation period:
- 14 days (44 hours after the last application)
- Number of animals:
- 6
- Details on study design:
- 24 hours befor the first treatment, the dorsal fur was shaved with electric clippers, exposing an area of appr. 150 cm² (10x15 cm²).
Whenever considered necessary during the cours of the study, the skin areas concerned of the animals were re-shaved at least 3 hours before the next skin reading.
TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: moistened Scotchpak-non.woven patch mounted on Micropore tape. The dressing was wrapped around the abdomen and secured with an elastic bandage.
A similar patch without test substance and vehicle ws applied to the contralateral flank, to act as a concurrent control.
REMOVAL OF TEST SUBSTANCE
- using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD Guideline 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 14 days daily after and before application
- Score:
- 0.77
- Max. score:
- 4
- Reversibility:
- other: score 1 was prevalent 44 hrs after last exposure in two animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 14 days daily after and before application
- Score:
- 0.36
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight or well defined erythema with or without very slight oedema.
No evidence of a corrosive effect on the skin. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to this subacute 14-day skin irritation/corrosion study, the test substance is not irritant to skin.
- Executive summary:
In a subacute 14-day skin irritation/corrosion study, 10 repeated dermal applications of Ceramide III (0.5 g) to six New Zealand White rabbits resulted in very slight or well-defined erythema with or without very slight oedema. In all cases, the irritation had resolved within 20 hours after the last (tenth) exposure in four animals, whereas very slight erythema persisted until termination in two animals.
There was no indication of enhancement of the skin irritation after daily, repeated exposure of the same skin-area and no signs of irreversible effects on the skin were obtained during the observation period.
According to this study, Ceramide III is not irritant to skin.
Referenceopen allclose all
IRRITATION
No skin irritation was caused by the test substance after a 4 h dermal application.
CORROSION
There was no evidence of a corrosive effect on the skin.
COLOURATION
No staining of the treated skin by the test substance was observed.
TOXICITY SYMPTOMS, MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period. No mortality occurred.
Table: Irritant/corrosive response data at each observation time point (mean of all animals).
Score at time point / Reversibility | Erythema | Edema |
Max. score: 4 | Max. score: 4 | |
50 min | 0/0/0 | 0/0/0 |
24 h | 0/0/0 | 0/0/0 |
48 h | 0/0/0 | 0/0/0 |
72 h | 0/0/0 | 0/0/0 |
Average 24h, 48h, 72h | 0/0/0 | 0/0/0 |
Skin irritation scores:
Animal No. | 1908 | 1912 | 1915 | 1921 | 1923 | 1927 | |
ER OE | ER OE | ER OE | ER OE | ER OE | ER OE | ||
Day 1 | after exposure | 1 1 | 1 1 | 1 0 | 1 1 | 1 0 | 1 0 |
Day 2 | before application | 1 0 | 1 0 | 0 0 | 0 0 | 0 0 | 0 0 |
after exposure | 2 1 | 2 1 | 2 1 | 2 1 | 2 1 | 2 1 | |
Day 3 | before application | 1 0 | 1 0 | 0 0 | 1 0 | 1 0 | 1 0 |
after exposure | 2 1 | 2 1 | 2 1 | 2 1 | 2 1 | 2 1 | |
Day 4 | before application | 1 0 | 1 0 | 0 0 | 0 0 | 1 0 | 0 0 |
after exposure | 2 1 | 2 1 | 2 1 | 2 1 | 1 1 | 2 1 | |
Day 5 | before application | 0 0 | 1 0 | 0 0 | 0 0 | 0 0 | 0 0 |
after exposure | 2 1 | 2 1 | 2 1 | 2 1 | 2 1 | 2 1 | |
Day 6 | 20 hrs after exposure | 0 0 | 1 0 | 0 0 | 0 0 | 0 0 | 0 0 |
Day 7 | 44 hrs after exposure | 0 0 | 1 0 | 0 0 | 0 0 | 0 0 | 0 0 |
Day 8 | before application | 0 0 | 0 0 | 0 0 | 0 0 | 0 0 | 0 0 |
after exposure | 1 1 | 1 1 | 1 1 | 1 1 | 1 1 | 2 1 | |
Day 9 | before application | 0 0 | 0 0 | 0 0 | 0 0 | 0 0 | 1 0 |
after exposure | 1 1 | 1 1 | 1 1 | 1 1 | 1 1 | 2 1 | |
Day 10 | before application | 0 0 | 0s 0 | 0s 0 | 0 0 | 0 0 | 0 0 |
after exposure | 1 1 | 1s 1 | 1 0 | 1 1 | 1 0 | 1 1 | |
Day 11 | before application | 0 0 | 0s 0 | 0s 0 | 0s 0 | 0s 0 | 0 0 |
after exposure | 1 1 | 1 1 | 1 1 | 1 1 | 1 0 | 2 1 | |
Day 12 | before application | 0s 0 | 0s 0 | 0s 0 | 0 0 | 0s 0 | 0 0 |
after exposure | 1 1 | 1 1 | 1 1 | 1 1 | 2 1 | 2 1 | |
Day 13 | 20 hrs after exposure | 0s 0 | 1s 0 | 0s 0 | 0 0 | 0s 0 | 1s 0 |
Day 14 | 44 hrs after exposure | 0 0 | 1 0 | 0 0 | 0 0 | 0 0 | 1 0 |
ER= Erythema | |||||||
OE= Oedema | |||||||
s= Scaliness |
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:
- 1994-10-31 to 1994-11-03
- 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:
- February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- December 1992
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 8-14 weeks
- Weight at study initiation: 2100 - 2604 g
- Housing: individual housing in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: ad libitum, standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day. In addition, hay (BMI Helmond, The Netherlands) was provided once a week.
- Water: ad libitum, tap-water diluted with decalcified water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod: fluorescent light (120 lux) 12 hours daily - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 27 +-2 mg (a volume of approx. 0.1 ml)
- Concentration: undiluted - Duration of treatment / exposure:
- 24 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- After 24 hours (immediately after fluorescein examination) both eyes of one animal was rinsed with approx. 50 ml tepid tap water per eye, using a velocity of flow which did not affect the eyes, to remove residual test substance.
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1 h, 24 h, 48 h, 72 h after treatment. Besides the eyes were examined for potential eye lesions 24 h by means of 2 % fluorescein-dilution.
It was washed out with 50 ml tepid tap-water per eye, using a velocity of flow which did not affect the eyes, to remove residual test substance. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- None described.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this in vivo study, the test item was not irritating to the rabbit eye and thus, no classification is required.
- Executive summary:
An acute eye irritation/corrosion study with Ceramide III in the rabbit was carried out in accordance with the OECD guideline No. 405, “Acute Eye Irritation/Corrosion” (February 24, 1987) and the EEC Directive 92/69 /EEC, B.5, “Acute Toxicity - Eye irritation” (December 1992).
Instillation of 27 mg of Ceramide III (a volume of approx. 0.1 ml) into an eye of each of three male New Zealand White albino rabbits resulted in effects on the iris and the conjunctivae in all animals. The untreated eye served as concurrent negative control. The irritation had resolved within 24 hours in two animals and within 72 hours after instillation in the third animal. The mean 24-72 h irritation score for all was 0.0 except for conjunctival redness (1.0) in one rabbit, which resolved completely after 72 h as described above.
No signs of systemic intoxication were observed during the study period.
In conclusion, Ceramide III was not irritating to the rabbit eye in this in vivo study.
Reference
IRRITATION
Instillation of 27 mg (a volume of approx. 0.1 ml) into one eye of each of the animals resulted in effects in the iris and the conjunctivae.
The iridic irritation (grade 1) had resolved within 24 hours in all three animals. The irritation of the conjunctivae consisted of redness of the conjunctival tissues and had resolved within 24 hours in two animals and within 72 hours after instillation in the third animal. A small amount of discharge was also noted in the latter animal on day 1.
Remnants of the test substance were noted in the treated eyes on day 1 and/or 2.
CORROSION
There was no evidence of ocular corrosion.
COLOURATION
Remnants of the test substance were noted on the outside of the eyelids on day 1 and/or 2.
TOXIC SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
The individual scores of each of the three animals and the average score (24, 48, 72 h) are given in the table below.
|
CORNEA |
IRIS |
CONJUNCTIVAE |
CHEMOSIS |
Max. score |
4 |
2 |
3 |
4 |
Time point (h) |
||||
1 |
0/0/0 |
1/1/1 |
0/0/1 |
0/0/1 |
24 |
0/0/0 |
0/0/0 |
0/0/2 |
0/0/0 |
48 |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
72 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24, 48, 72 |
0 |
0 |
1 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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