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EC number: 203-845-5 | CAS number: 111-20-6
- 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
No skin reactions were observed in an OECD 404 study performed in Vienna White rabbits.
During an eye irritation test according to OECD 405, Vienna White rabbits only showed slight redness of the conjuntivae which was reversible in all animals within 7 days.
The substance was not irritating in both in vivo tests.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Conelli S.n.c., Arona (Italy)
- Age at study initiation:about 2-3 months old
- Weight at study initiation: 2-3 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): automatic watering valve system
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 10-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g (6 cm²) - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- Immediately and 72 hours after the 3-minute and the 1-hour exposure period in the first rabbit and at 1,24,48 and 72 hours after the 4-hours exposure period (all rabbits).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- mean
- 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neither mortality nor adverse general clinical modifications were seen during the study.
The test substance administered to rabbits by the dermal route, is to be considered "NON IRRITANT" for the skin.
Reference
Table 1: Dermal erythema reactions after four hours of exposure.
Exp. Period 4 h Erythema and Eschar |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Table 2: Dermal edema reactions after four hours of exposure.
Exp. Period 4 h Edema |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conelli S.n. c. Arona (Italy)
- Age at study initiation: about 2-3 months old
- Weight at study initiation: about 2-3 kg
- Diet: ad libitum
- Water: automatic watering valve system
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 15-20 air changes
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance administered to rabbits as a single ocular application, is to be considered "NON IRRITANT" for the eye.
Reference
Table 1: Eye reaction redness observed during the study.
Conjunctivae: Redness |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
2 |
2 |
2 |
24 hours |
2 |
2 |
2 |
48 hours |
1 |
2 |
2 |
72 hours |
0 |
1 |
1 |
7 days |
0 |
0 |
0 |
Table 2: Eye swelling reactions observed during the study.
Conjunctivae: Chemosis |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
Table 3: Opacity reactions observed during the course of the study.
Cornea: Opacity |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
Table 4: Effects on the iris observed during the course of the study.
Iris: Iritis |
Animal # |
||
Obs. Made at |
56M |
58M |
59M |
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
7 days |
0 |
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 / CORROSION
In the key GLP study, which was done according to the OECD guideline 404, rabbits were occlusively exposed to sebacic acid for 4 h. No mortality or adverse general clinical modifications were seen during the observation period of 72 h and the erythema and edema scores (24/48/72 h) were zero. In a supporting study (Gibraltar Biol. Lab. Rep., 1985) rabbits were occlusively exposed to sebacic acid and the erythema and edema scores (24/48/72 h) were also zero. An additional supporting study (AMRL, 1976) showed also no irritation after occlusive exposure of rabbits to sebacic acid for up to 20 h.
Therefore, sebacic acid is considered to be non-irritant for the skin.
EYE IRRITATION
In the key GLP study rabbits were exposed to sebacic acid for 24 h. Conjunctival redness was observed in all three animals resulting in a mean conjunctivae score (24/48/72 h) of 1.44. The effect was reversible within 7 days. All other scores (cornea, iris and chemosis scores) were zero. The substance was regarded as a non-irritant. In a supporting study (Gibraltar Biol. Lab. Rep., 1985) similar results were observed with the cornea and iris scores = 0 and conjuctival and chemosis scores below 1; all scores: mean over 6 animals and 24/48/72 h. The observed effects were reversible within 48 h.
Therefore, sebacic acid is considered to be non-irritant for the eyes.
RESPIRATORY IRRITATION
There is no information available concerning respiratory irritation.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.
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