Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 293-411-1 | CAS number: 91079-24-2
Toxicological information
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: negative
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
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The similarity of the substance with the representative samples of sulfated oils is detailed in section 13.2.
The substance was investigated within a screening testing programme using the LLNA method, together with the other representative samples of sulfated oils, and an ambiguous weakly positive result was found for the substances, providing further evidence that their behaviour is similar.
Given the concerns of the applicability of the LLNA method for these substances, a confirmatory test was undertaken of the representative sample with the highest SI in the LLNA studies (CSO3), using the OECD method described in guideline no. 406. Given the above, the result of this further study is considered to be valid for all the sulfated oils considered, including the substance. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A screening testing programme was carried out on seven sulfated oils representative samples using the Local Lymph Node Assay (LLNA: BrdU-ELISA method). Ambiguous results were found, suggesting weakly "positive" outcomes in the absence of QSAR flags for protein-binding (OECD toolbox) implying a false positive response. Thus, a confirmatory assay was undertaken using the GPMT on the substance for which the highest SI value was fouind in the LLNA testing programme (CSO3, SI = 6.27).
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 403-480 g
- Housing: Up to 5 animals/cage noryl cages measuring 74.3 x 54.3 x 25 cm
- Diet (e.g. ad libitum): 8GP17 (Mucedola Srl) diet available ad libitum
- Water (e.g. ad libitum): tap water available ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2012-08-27 To: 2012-10-06 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 % - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 % - No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
A dose range finding was performed in a preliminary study. 0.1 ml of test substance in water at various concentrations were injected intracutaneously into the skin of the scapula region. 24 hours and 7 days after application skin reaction was assessed.
For dermal applications various concentrations of the substance in water were applied on patches of 2x2 cm to the clipped skin. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): test substance in vehicle at 0.5% concentration and in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 5 % test substance in water (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: dermal treatment
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 1 %
- Evaluation: 24 and 48 hours after removal of dressings - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- alfa-HEXYLCINNAMALDEHYDE
- Positive control results:
- REFERENCE SUBSTANCE: alfa-HEXYLCINNAMALDEHYDE
CONCENTRATION: INDUCTION (INJECTION) - 20% in corn oil
(TOPICAL) - 50% in corn oil
CHALLENGE - 10% in acetone
CRITICAL DATES: INDUCTION (INJECTION) - 21 August 2012
(TOPICAL) - 28 August 2012
CHALLENGE - 11 September 2012
RESULTS: 70% response in test group and 0% response in control group at challenge.
INTERPRETATION: Incidence at challenge acceptable. Test system regarded as valid. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 24 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 24 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 48 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 48 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not sensitising
- Conclusions:
- Delayed dermal sensitisation has been investigated using the maximisation test according to OECD/EU test guideline No. 406. The substance did not induce delayed dermal sensitisation in the guinea pig.
- Executive summary:
Delayed dermal sensitisation has been investigated using the maximisation test according to OECD/EU test guideline No. 406. The substance did not induce delayed dermal sensitisation in the guinea pig.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A screening testing programme was carried out on seven sulfated oils representative samples using the Local Lymph Node Assay (LLNA: BrdU-ELISA method). Ambiguous results were found, suggesting weakly "positive" outcomes in the absence of QSAR flags for protein-binding (OECD toolbox) implying a false positive response. Thus, a confirmatory assay was undertaken using the GPMT on the substance for which the highest SI value was fouind in the LLNA testing programme (CSO3, SI = 6.27).
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 403-480 g
- Housing: Up to 5 animals/cage noryl cages measuring 74.3 x 54.3 x 25 cm
- Diet (e.g. ad libitum): 8GP17 (Mucedola Srl) diet available ad libitum
- Water (e.g. ad libitum): tap water available ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2012-08-27 To: 2012-10-06 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 % - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Concentrations used for induction: intradermal treatment: 0.5% in water; dermal treatment: 5 % in water
- Concentration in Freunds Complete Adjuvant (FCA): 0.5% test substance in a mixture of FCA and water (1:1)
- Concentrations used for challenge: 1 % - No. of animals per dose:
- test group: 20 animals
control group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
A dose range finding was performed in a preliminary study. 0.1 ml of test substance in water at various concentrations were injected intracutaneously into the skin of the scapula region. 24 hours and 7 days after application skin reaction was assessed.
For dermal applications various concentrations of the substance in water were applied on patches of 2x2 cm to the clipped skin. The patches were removed after 24 hours and dermal reactions were read immediately, 24 and 48 hours after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1st exposure: intracutaneous injections (0.1 cm³); 2nd exposure: epicutaneous for 48 hours; evaluation after 24 hours each
- Concentration in Freunds Complete Adjuvants (FCA): test substance in vehicle at 0.5% concentration and in a mixture of FCA and vehicle (1:1)
- Test group: dermal: 5 % test substance in water (2 x 4 cm patch)
- Control group: vehicle (2 x 4 cm patch)
- Frequency of applications: day 1: intradermal treatment, day 8: dermal treatment
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 22
- Exposure period: dermal application for 24 hours
- Test groups: test substance (2 x 2 cm patch)
- Control group: test substance (2 x 2 cm patch)
- Site: left flanks
- Concentrations: 1 %
- Evaluation: 24 and 48 hours after removal of dressings - Challenge controls:
- see above B. Challenge exposure
- Positive control substance(s):
- yes
- Remarks:
- alfa-HEXYLCINNAMALDEHYDE
- Positive control results:
- REFERENCE SUBSTANCE: alfa-HEXYLCINNAMALDEHYDE
CONCENTRATION: INDUCTION (INJECTION) - 20% in corn oil
(TOPICAL) - 50% in corn oil
CHALLENGE - 10% in acetone
CRITICAL DATES: INDUCTION (INJECTION) - 21 August 2012
(TOPICAL) - 28 August 2012
CHALLENGE - 11 September 2012
RESULTS: 70% response in test group and 0% response in control group at challenge.
INTERPRETATION: Incidence at challenge acceptable. Test system regarded as valid. - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 24 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 24 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 48 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Responses observed 48 h after challange by 24 h topical exposure to test item at 1% concentration and vehicle alone
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not sensitising
- Conclusions:
- Delayed dermal sensitisation has been investigated using the maximisation test according to OECD/EU test guideline No. 406. The substance did not induce delayed dermal sensitisation in the guinea pig.
- Executive summary:
Delayed dermal sensitisation has been investigated using the maximisation test according to OECD/EU test guideline No. 406. The substance did not induce delayed dermal sensitisation in the guinea pig.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The potential for dermal sensitisation of the substance and the other representative substances of sulfated oils has been evaluated using OECD test methods (OECD 442B - Skin sensitisation: Local lymph node assay: BrdU-ELISA). Treatment resulted in an increase in cell proliferation of draining lymph nodes in treated animals when compared to controls, indicating that these substances may elicit a sensitisation response in mice. The ambiguous weakly positive results, unexpected given the lack of any structural alerts for sensitisation, were considered unreliable against a confirmatory assay, using the guinea pig maximisation test, which resulted in negative findings.
It is possible that the specific LLNA method used is not suited to this class of substance (see also Kreiling et al. (2008) Food Chem Toxicol 46: 1896 -1904), QSAR (OECD Toolbox) giving no structural alerts for sensitisation arising from protein binding.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available information indicate that the substance does not meet the creiteria for classification as skin sensitising according to Regulation 1272/2008/EC (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.
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.
