Registration Dossier
Registration Dossier
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EC number: 291-076-6 | CAS number: 90320-49-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Amyris balsamifera, Rutaceae.
Endpoint summary
Administrative data
Description of key information
Skin Sensitisation (human maximisation test): sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to valid method (human maximisation test; Kligman 1966), but not according to OECD guideline or GLP
- Qualifier:
- no guideline followed
- Version / remarks:
- Test was performed according to valid method (human maximisation test; Kligman 1966)
- Principles of method if other than guideline:
- - Principle of test: Test was performed according to valid method (human maximisation test; Kligman J.I.D.; Vol 47; No 5; 393-409; 1966)
- GLP compliance:
- no
- Remarks:
- GLP was not yet enforced at the time
- Type of study:
- patch test
- Justification for non-LLNA method:
- As the results of a previously performed human maximisation test are already available, this data will be used for the WoE evaluation.
- Specific details on test material used for the study:
- Not specified further
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Inmate volunteers
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 5 alternate-day 48 hour periods
- Adequacy of induction:
- other: Non-irritant substance, but skin pre-treated with 5% aqueous sodium lauryl sulphate
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Skin pretreated with 1h application of 10% aqeous sodium Lauryl Suplhate under occlusion, before challenge.
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- RANGE FINDING TESTS: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: five (alternate-days)
- Exposure period: 5 alternate-day 48-hour periods
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms
- Frequency of applications: once per exposure
- Duration: 48-hour periods
- Pre-treatment: patch sites were pre-treated for 34 hours with 5% aqueous sodium lauryl sulphate under occlusion
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: 10 days after last application (10 day rest period)
- Exposure period: 48 hours
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms (fresh site)
- Evaluation (hr after challenge): on removal of the patch and 24 hours thereafter
- Pre-treatment: Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Positive control results:
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- pure
- No. with + reactions:
- 2
- Total no. in group:
- 25
- Clinical observations:
- Contact sensitisation observed, clinical effects are not further specified
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 2
- Total no. in group:
- 25
- Clinical observations:
- Contact sensitisation observed, clinical effects are not further specified
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: Sub-category 1B: potential to produce sensitisation
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the substance produced 2 cases of contact-sensitisation and can be considered a weak sensitizer. Based on the results of this study the test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
- Executive summary:
Pre-Testing: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
Maximization test: (Kligman; J.I.D.; Vol 47; No 5; 393-409; 1966) the material was applied under occlusion to the volar forearms of 25 male healthy inmate volunteers, for five alternate-day 48-hour periods. The patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion. Following a ten-day rest-period, challenge patches of the material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
Under the conditions of the test, the substance produced 2 cases of contact-sensitisation and can be considered a weak sensitizer. Based on the results of this study the test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not-specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to valid method (human maximisation test; Kligman 1966), but not according to OECD guideline or GLP
- Qualifier:
- no guideline followed
- Version / remarks:
- Test was performed according to valid method (human maximisation test; Kligman 1966)
- Principles of method if other than guideline:
- - Principle of test: Test was performed according to valid method (human maximisation test; Kligman J.I.D.; Vol 47; No 5; 393-409; 1966)
- GLP compliance:
- no
- Remarks:
- GLP was not yet enforced at the time
- Type of study:
- patch test
- Justification for non-LLNA method:
- As the results of a previously performed human maximisation test are already available, this data will be used for the WoE evaluation.
- Specific details on test material used for the study:
- Not specified further
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Inmate volunteers
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Nopt specified
- Day(s)/duration:
- 5 alternate-day 48-hour periods
- Adequacy of induction:
- other: non-irritant substance, but pre-treated with 5% aqueous sodium lauryl suplhate under occlusion
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Skin pretreated with 1h application of 10% aqeous sodium Lauryl Suplhate under occlusion, before challenge.
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- RANGE FINDING TESTS: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: five (alternate-days)
- Exposure period: 5 alternate-day 48-hour periods
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms
- Frequency of applications: once per exposure
- Duration: 48-hour periods
- Pre-treatment: patch sites were pre-treated for 34 hours with 5% aqueous sodium lauryl sulphate under occlusion
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: 10 days after last application (10 day rest period)
- Exposure period: 48 hours
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms (fresh site)
- Evaluation (hr after challenge): on removal of the patch and 24 hours thereafter
- Pre-treatment: Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 2
- Total no. in group:
- 25
- Clinical observations:
- Contact sensitisation observed, clinical effects are not further specified
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 2
- Total no. in group:
- 25
- Clinical observations:
- Contact sensitisation observed, clinical effects are not further specified
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: Sub-category 1B: potential to produce sensitisation
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the substance produced 2 cases of contact-sensitisation and can be considered a weak sensitizer. Based on the results of this study the test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
- Executive summary:
Pre-Testing: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
Maximization test: (Kligman; J.I.D.; Vol 47; No 5; 393-409; 1966) the material was applied under occlusion to the volar forearms of 25 male healthy inmate volunteers, for five alternate-day 48-hour periods. The patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion. Following a ten-day rest-period, challenge patches of the material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
Under the conditions of the test, the substance produced 2 cases of contact-sensitisation and can be considered a weak sensitizer. Based on the results of this study the test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not-specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to valid method (human maximisation test; Kligman 1966), but not according to OECD guideline or GLP
- Qualifier:
- no guideline followed
- Version / remarks:
- Test was performed according to valid method (human maximisation test; Kligman 1966)
- Principles of method if other than guideline:
- - Principle of test: Test was performed according to valid method (human maximisation test; Kligman J.I.D.; Vol 47; No 5; 393-409; 1966)
- GLP compliance:
- no
- Remarks:
- GLP was not yet enforced at the time
- Type of study:
- patch test
- Justification for non-LLNA method:
- As the results of a previously performed human maximisation test are already available, this data will be used for the WoE evaluation.
- Specific details on test material used for the study:
- Low Gravity
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Inmate volunteers
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Nopt specified
- Day(s)/duration:
- 5 alternate-day 48-hour periods
- Adequacy of induction:
- other: non-irritant substance, but pre-treated with 5% aqueous sodium lauryl suplhate under occlusion
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Skin pretreated with 1h application of 10% aqeous sodium Lauryl Suplhate under occlusion, before challenge.
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- RANGE FINDING TESTS: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: five (alternate-days)
- Exposure period: 5 alternate-day 48-hour periods
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms
- Frequency of applications: once per exposure
- Duration: 48-hour periods
- Pre-treatment: patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: 10 days after last application (10 day rest period)
- Exposure period: 48 hours
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms (fresh site)
- Evaluation (hr after challenge): on removal of the patch and 24 hours thereafter
- Pre-treatment: Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: No classification
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the substance produced no contact-sensitisation. Based on the results of this study the test substance does not need to be classified as a skin sensitizer in accordance with the CLP Regulation (1272/2008/EC).
- Executive summary:
Pre-Testing: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
Maximization test: (Kligman; J.I.D.; Vol 47; No 5; 393-409; 1966) the material was applied under occlusion to the volar forearms of 25 male healthy inmate volunteers, for five alternate-day 48-hour periods. The patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion. Following a ten-day rest-period, challenge patches of the material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. Under the conditions of the test, the substance produced no contact-sensitisation. Based on the results of this study the test substance does not need to be classified as a skin sensitizer in accordance with the CLP Regulation (1272/2008/EC).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not-specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to valid method (human maximisation test; Kligman 1966), but not according to OECD guideline or GLP
- Qualifier:
- no guideline followed
- Version / remarks:
- Test was performed according to valid method (human maximisation test; Kligman 1966)
- Principles of method if other than guideline:
- - Principle of test: Test was performed according to valid method (human maximisation test; Kligman J.I.D.; Vol 47; No 5; 393-409; 1966)
- GLP compliance:
- no
- Remarks:
- GLP was not yet enforced at the time
- Type of study:
- patch test
- Justification for non-LLNA method:
- As the results of a previously performed human maximisation test are already available, this data will be used for the WoE evaluation.
- Specific details on test material used for the study:
- high gravity
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Inmate volunteers
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Nopt specified
- Day(s)/duration:
- 5 alternate-day 48-hour periods
- Adequacy of induction:
- other: non-irritant substance, but pre-treated with 5% aqueous sodium lauryl suplhate under occlusion
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Not Specified
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- other: Skin pretreated with 1h application of 10% aqeous sodium Lauryl Suplhate under occlusion, before challenge.
- No. of animals per dose:
- 25 volunteers
- Details on study design:
- RANGE FINDING TESTS: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: five (alternate-days)
- Exposure period: 5 alternate-day 48-hour periods
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms
- Frequency of applications: once per exposure
- Duration: 48-hour periods
- Pre-treatment: patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: 10 days after last application (10 day rest period)
- Exposure period: 48 hours
- Test groups: 25 male healthy inmate volunteers
- Control group: n/a
- Site: volar forearms (fresh site)
- Evaluation (hr after challenge): on removal of the patch and 24 hours thereafter
- Pre-treatment: Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Pure
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: No classification
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the substance produced no contact-sensitisation. Based on the results of this study the test substance does not need to be classified as a skin sensitizer in accordance with the CLP Regulation (1272/2008/EC).
- Executive summary:
Pre-Testing: The materials were pre-tested on five subjects. Amyris Oil was applied to the (untreated) backs of 5 healthy male volunteers for 48 hours under occlusion. After this period the site was inspected, and no sign of irritation was observed. Based on this result the maximisation test was performed using an SLS pre-treatment.
Maximization test: (Kligman; J.I.D.; Vol 47; No 5; 393-409; 1966) the material was applied under occlusion to the volar forearms of 25 male healthy inmate volunteers, for five alternate-day 48-hour periods. The patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion. Following a ten-day rest-period, challenge patches of the material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. Under the conditions of the test, the substance produced no contact-sensitisation. Based on the results of this study the test substance does not need to be classified as a skin sensitizer in accordance with the CLP Regulation (1272/2008/EC).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation
Four studies were available, which were used in a weight of evidence approach. All studies were performed according the human skin maximisation test by Kligman; J.I.D.; Vol 47; No 5; 393-409; 1966. After a pre-test to assess irritation, the material was applied under occlusion to the volar forearms of 25 male healthy inmate volunteers, for five alternate-day 48-hour periods. The patch sites were pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion. Following a ten-day rest-period, challenge patches of the material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulphate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
In studies 1804 05/18 as well as 1804 05/18A, the Amyris Oil was found to produce 2 cases of contact-sensitisation (out of 25 tested subjects) and was considered a weak sensitizer. In the other two studies1804 11/01A,1804 11/01Cand Amyris Oil(specified as Amyris Oil - Low Gravity and Amyris Oil - High gravity), produced no contact-sensitisation in any of the 25 subjects.
Though contact sensitisation was not always observed in the 4 studies, some cases of contact-sensitation were reported. The 4 studies combined comprise 100 individuals, which have presented 4 cases of sensitisation. From this data it can be concluded that Amyris Oil shows a low frequency of occurrence in humans can be presumed to have the potential to produce sensitisation in humans. The test substance should therefore be classified as a skin sensitizer (Sub-category 1B) in accordance with the CLP Regulation (1272/2008/EC).
Justification for classification or non-classification
Based on the available in vivo human data for skin sensitisation, Amyris oil should be classified as a skin sensitizer (Skin Sens. 1B / H317) in accordance with the CLP Regulation (1272/2008/EC).
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.
