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EC number: 214-540-1 | CAS number: 1143-72-2
- 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 the study conducted with the read-across source substance, the test item is considered to be a potentially strong skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 1% in sesame oil, 1% in 50% Freund`s Adjuvants and 50% Freund`s Adjuvant, repectively (intradermal), 25% in sesame oil (epicutaneous); challenge: 25% in sesame oil
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed. Discrete or patchy erythema (5/10) and moderate to confluent erythema (1/10) were noted.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1% in sesame oil, 1% in 50% Freund`s Adjuvants and 50% Freund`s Adjuvant, repectively (intradermal), 25% in sesame oil (epicutaneous); challenge: 25% in sesame oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity occured. Discrete to patchy erythema (1/10), moderate to confluent erythema (6/10) and intense erythema and swelling (3/10) were observed. Dry, rough and scaly skin (10/10) and skin induration (9/10) were noted.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: sesame oil, 50% Freund`s Adjuvants and sesame oil in 50% Freund`s Adjuvant, repectively (intradermal), sesame oil (epicutaneous); challenge: 25% in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions and signs of systemic toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: sesame oil, 50% Freund`s Adjuvants and sesame oil in 50% Freund`s Adjuvant, repectively (intradermal), sesame oil (epicutaneous); challenge: 25% in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions and signs of systemic toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Challenge: 25% α-hexylcinnamaldehyde in polyethylene glycole 400
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Discrete to patchy erythema (1/10), moderate to confluent erythema (2/10) and intense erythema and swelling (5/10) were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Challenge: 25% α-hexylcinnamaldehyde in polyethylene glycole 400
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Discrete to patchy erythema (1/10), moderate to confluent erythema (2/10) and intense erythema and swelling (6/10) were observed.
- Remarks on result:
- positive indication of skin sensitisation
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No study data with the test item is available for skin sensitisation. Therefore, a read-across to the read-across substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the potential for skin senitisation potential of the test item.
A study according to OECD TG 406 was conducted to evaluate the skin sensitisation potential of the test material. Female guinea pigs received intradermal induction with 1 % test item in sesame oil, while dermal induction and challenge treatment was carried out with 25 % test item in sesame oil. No systemic toxicity was observed and the mean value for body weight and the body weight gain were comparable between the treatment group and control group. Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in sesame oil showed slight erythema and edema. Intradermal injections of the sesame oil alone exhibited no signs of irritation. Due to these strong irritation reactions of the skin, 10 % sodium dodecylsulfate was not administered at day 7. Severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed after dermal induction treatment at the sites previously treated with Freund's Adjuvant after the removal of the patches on day 10. The administration sites treated with the test substance or the sesame oil alone showed no signs of irritation. After the dermal challenge no skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage. Six animals in the main test group showed very slight up to slight erythema 24 hours after removal of the occlusive bandage. 48 hours after removal of the occlusive bandage all animals showed positive skin reactions ranging from slight erythema to intense erythema and swelling. Additionally, induration, dry, rough and scally skin were observed. Under the conditions of the present study, all of ten animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study the test item may cause sensitization by skin contact.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item requires classification for skin sensitisation potential Category 1 (H317: May cause an allergic skin reaction) according to Regulation (EC) No 1272/2008 (CLP).
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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