Registration Dossier
Registration Dossier
Diss Factsheets
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: 946-413-8 | CAS number: -
- 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
LLNA, not a skin sensitizer (read-across substance Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by hexane extraction; OECD 429, GLP, K, Rel. 1)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 27 July to 06 September 2017
- Justification for type of information:
- The source substance and the target substance have the same botanical origin
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- The positive control α Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 (13.45) when tested at a concentration of 25% v/v in acetone/olive oil 4:1, thus, demonstrating the sensitivity and reliability of the test system.
- Key result
- Parameter:
- SI
- Value:
- 1.67
- Test group / Remarks:
- 5% w/w in acetone/olive oil 4:1
- Key result
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- 10% w/w in acetone/olive oil 4:1
- Key result
- Parameter:
- SI
- Value:
- 2.79
- Test group / Remarks:
- 25% w/w in acetone/olive oil 4:1
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA:
See Table 7.4.1/1 below.
DETAILS ON STIMULATION INDEX CALCULATION
Stimulation index for 5, 10 and 25% v/v in acetone/olive oil 4:1 were 1.67, 1.59 and 2.79, respectively.
CLINICAL OBSERVATIONS: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test (See Table 7.4.2 & 7.4.3 below).
EAR THICKNESS: No treatment group showed an equal to or greater than 25% increase in mean ear thickness over the observation period.
BODY WEIGHTS: Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item is considered to be a non-sensitizer under the conditions of the test. Therefore the registered substance is also considered to be a non-sensitizer.
- Executive summary:
A study was performed to assess the skin sensitisation potential of test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was conducted according to the OECD test guideline No 429 and in compliance with GLP.
Following a preliminary screening test at a concentration of 50% w/w in which a greater than 25% increase in ear thickness was noted, a further screening test at a concentration of 25% w/w was performed. No clinical signs of toxicity or excessive local irritation were noted at a concentration of 25% w/w and therefore this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 25%,10% or 5% w/w. A further group of five animals was treated withacetone/olive oil 4:1 alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, α‑Hexylcinnamaldehyde, technical grade, 85%, at a concentration of 25% v/v inacetone/olive oil 4:1
The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-methyl Thymidine (3HTdR) by β-scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio), termed as Stimulation Index (SI).
Stimulation index for 25%, 10% or 5% w/w in acetone/olive oil 4:1 were 2.79, 1.59 and 1.67, respectively. Calculation of an EC3 value was not possible due to the negative result obtained at each concentration tested. No signs of systemic toxicity or excessive local skin irritation were noted at the concentrations of 25%,10% or 5% w/w.
The positive control α-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 (13.45) when tested at a concentration of 25% v/v in acetone/olive oil 4:1, thus, demonstrating the sensitivity and reliability of the test system.
Under the test conditions, the test item was considered to be a non-sensitizer under the conditions of the test.
This study is considered as acceptable and satisfies the requirement for sensitisation endpoint.
Reference
Table 7.4.1/1: Individual Disintegrations per Minute and Stimulation Index
Treatment Group |
Animal Number |
dpm/ |
Mean dpm/Animal |
Stimulation Indexb |
Result |
Vehicle |
1-1 |
1081.68 |
1206.96 |
na |
na |
1-2 |
1038.55 |
||||
1-3 |
1645.81 |
||||
1-4 |
887.26 |
||||
1-5 |
1381.52 |
||||
Test Item |
2-1 |
1353.33 |
2020.02* |
1.67 |
Negative |
2-2 |
2581.54 |
||||
2-3 |
1722.25 |
||||
2-4 |
2688.00 |
||||
2-5 |
1754.99 |
||||
Test Item |
3-1 |
1203.98 |
1922.29 |
1.59 |
Negative |
3-2 |
1795.78 |
||||
3-3 |
1422.01 |
||||
3-4 |
2390.86 |
||||
3-5 |
2798.84 |
||||
Test Item |
4-1 |
2140.11 |
3371.42** |
2.79 |
Negative |
4-2 |
3989.73 |
||||
4-3 |
4888.40 |
||||
4-4 |
2875.62 |
||||
4-5 |
2963.22 |
||||
Positive Control Item |
5-1 |
12499.31 |
16238.89** |
13.45 |
Positive |
5-2 |
21524.30 |
||||
5-3 |
20373.82 |
||||
5-4 |
15387.17 |
||||
5-5 |
11409.83 |
dpm= Disintegrations per minute
a= Total number of lymph nodes per animal is 2
b= Stimulation Index of 3.0 or greater indicates a positive result
Table 7.4.1/2: Individual Clinical Observations and Mortality Data
Treatment Group |
Animal Number |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
4-1 |
0 |
0 |
0 |
0Rt |
0 |
0Rt |
0 |
0 |
0 |
4-2 |
0 |
0 |
0 |
0Rt |
0 |
0Rt |
0 |
0 |
0 |
|
4-3 |
0 |
0 |
0 |
0Rt |
0 |
0Rt |
0 |
0 |
0 |
|
4-4 |
0 |
0 |
0 |
0Rt |
0 |
0Rt |
0 |
0 |
0 |
|
4-5 |
0 |
0 |
0 |
0Rt |
0 |
0Rt |
0 |
0 |
0 |
|
Positive Control Item |
5-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Rt = Sticky residual test item on the ears
Table 7.4.1/3: Local Skin Irritation
Treatment Group |
Animal Number |
Local Skin Irritation |
|||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||||||||
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
left |
right |
||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Test Item |
4-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Positive Control Item |
5-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was performed to assess the skin sensitisation potential of test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was conducted according to the OECD test guideline No 429 and in compliance with GLP.
Following a preliminary screening test at a concentration of 50% w/w in which a greater than 25% increase in ear thickness was noted, a further screening test at a concentration of 25% w/w was performed. No clinical signs of toxicity or excessive local irritation were noted at a concentration of 25% w/w and therefore this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 25%,10% or 5% w/w. A further group of five animals was treated withacetone/olive oil 4:1 alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, α‑Hexylcinnamaldehyde, technical grade, 85%, at a concentration of 25% v/v inacetone/olive oil 4:1
The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-methyl Thymidine (3HTdR) by β-scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio), termed as Stimulation Index (SI).
Stimulation index for 25%, 10% or 5% w/w in acetone/olive oil 4:1 were 2.79, 1.59 and 1.67, respectively. Calculation of an EC3 value was not possible due to the negative result obtained at each concentration tested. No signs of systemic toxicity or excessive local skin irritation were noted at the concentrations of 25%,10% or 5% w/w.
The positive control α-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 (13.45) when tested at a concentration of 25% v/v in acetone/olive oil 4:1, thus, demonstrating the sensitivity and reliability of the test system.
Under the test conditions, the test item was considered to be a non-sensitizer under the conditions of the test.
This study is considered as acceptable and satisfies the requirement for sensitisation endpoint.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Under the REACH regulation there is no legal standard information requirement in Annexes VII to X to perform any specific test for respiratory sensitisation. In addition, no validated or widely recognised in vitro or in vivo test methods specific to respiratory sensitisation are available yet. No human or animal data are available on the substance to address respiratory sensitisation. Due to the mostly unknown composition of the substance, it was not possible to use OECD QSAR Toolbox predictions.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the available data, the substance is not classified as a skin sensitizer according to the Regulation (EC) No. 1272/2008 (CLP) and to the Globally Harmonised System of classification and labelling of chemicals (GHS).
No direct scientific data are available on the substance to address respiratory sensitisation.
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.
