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Diss Factsheets
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EC number: 205-351-5 | CAS number: 139-07-1
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- 1. In the study, abraded and non abraded skin sites were used; however, the guideline recommends unabraded skin. 2. Exposure period was 24 h; however, guideline recommends 4 h exposure period
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The test substance was applied to both abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Test material
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24h
- Observation period:
- 24 and 72h
- Number of animals:
- 6
- Details on study design:
- Test site:
- Area of exposure: Back of animal
- Type of wrap if used: The patches consisted of two layers of light gauze cut in squares (2.5 cm on the side). The patches were secured to the test area by thin bands of adhesive tape and the trunk of each animal was wrapped in clear plastic trunk bands after application of the test substance.
- Type of test site: Two areas (intact and abraded) on the back of each animal placed approximately 10 cm apart
Scoring system:
- Skin reactions were scored for erythema and edema, according to Draize Woodland and Calvery scoring system. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 6.29
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Intact and abraded skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Abraded skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Intact skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Abraded skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- ca. 3.5 - ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3.5 for intact and 4 for abraded skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 / 72 h
- Score:
- ca. 3 - ca. 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3 for intact and 3.5 for abraded skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 / 72 h
- Score:
- ca. 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3.5 for intact and 3.5 for abraded skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 / 72 h
- Score:
- ca. 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3.5 for intact and 3.5 for abraded skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24 / 72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3 for intact and 3 for abraded skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24 / 72 h
- Score:
- ca. 3.5 - ca. 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 4 for intact and 3.5 for abraded skin)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 / 72 h
- Score:
- ca. 2.5 - ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 2.5 for intact and 3 for abraded skin)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 / 72 h
- Score:
- ca. 2.5 - ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 2.5 for intact and 3 for abraded skin)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3 for intact and 3 for abraded skin)
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- ca. 2.5 - ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 2.5 for intact and 3 for abraded skin)
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 3 for intact and 3 for abraded skin)
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- ca. 2.5 - ca. 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- (mean erythema score was: 2.5 for intact and 3 for abraded skin)
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: see below table for details on results
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: see below table for details on results
- Irritant / corrosive response data:
- - Severe erythema and edema were observed in animals with abraded and intact skin. See below table for individual animal scores at each time point.
- Interpretation of results:
- other: Category 1B (corrosive) based on CLP criteria
- Conclusions:
- Based on the results of the read across study, the test substance, C12 ADBAC, can be considered to be corrosive to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation / corrosion potential of the read across substance, C12 -16 ADBAC (50 -80% active), according to US EPA OPPTS 870.2500. The experiment was performed in rabbits. The undiluted test substance was applied on intact and abraded skin sites using occlusive patches for an exposure period of 24 h. The skin was then observed for erythema and edema formation and the scoring was done according to the Draize, Woodland and Calvery scoring system at 24 and 72 h from the onset of exposure. Severe erythema and edema were observed in all the test animals at both the abraded and intact sites. The mean Primary Irritation Index (PII) of the test substance was calculated to be 6.29 and the mean values of erythema and edema were 3.33 (intact skin site), 3.5 (abraded skin site), 2.66 (intact skin site) and 3 (abraded skin site). Under study conditions, C12 -16 ADBAC is considered to be corrosive to rabbit skin (Wallace, 1975). Based on the results of the read across study, the test substance, C12 ADBAC, can be considered to be corrosive to rabbit skin.
Table 1. Individual animal data on the skin irritation response
Rabbit no. |
Reaction |
24 h |
72 h |
||
Intact |
Abraded |
Intact |
Abraded |
||
1 |
Erythema |
4 |
4 |
3 |
4 |
Edema |
2 |
3 |
3 |
3 |
|
2 |
Erythema |
3 |
4 |
3 |
3 |
Edema |
2 |
3 |
3 |
3 |
|
3 |
Erythema |
4 |
4 |
3 |
3 |
Edema |
3 |
3 |
3 |
3 |
|
4 |
Erythema |
4 |
4 |
3 |
3 |
Edema |
2 |
3 |
3 |
3 |
|
5 |
Erythema |
3 |
3 |
3 |
3 |
Edema |
3 |
3 |
3 |
3 |
|
6 |
Erythema |
4 |
4 |
4 |
3 |
Edema |
2 |
3 |
3 |
3 |
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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