Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation: Sensitiser 1B, based on read across from Myrcenyl acetate which was tested in OECD TG 429, LLNA

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across information.
Justification for type of information:
The read across rationale is presented in the related Endpoint summary, the accompanying files are also attached there.
Reason / purpose for cross-reference:
read-across source
Key result
Parameter:
EC3
Value:
14
Remarks on result:
other: (%) / read-across from Myrcenyl acetate
Parameter:
other: NOAEC
Value:
10
Remarks on result:
other: (%) / read-across from Myrcenyl acetate
Parameter:
SI
Value:
2.11
Test group / Remarks:
10%
Remarks on result:
other: 10%
Parameter:
SI
Value:
6.3
Remarks on result:
other: 30%
Parameter:
SI
Value:
5.42
Remarks on result:
other: 100%
Interpretation of results:
other: Skin sensitiser Category 1B
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The SI values calculated for the source substance concentrations 5, 10 and 25% were 1.4, 1.5 and 3.7, respectively. These results show that the test substance could elicit a SI ≥ 3. The EC3 is calculated to be 14%. The substance is a skin sensitiser (Category 1B), based on the results of the source substance.
Endpoint:
skin sensitisation: in vivo (LLNA)
Remarks:
Study was conducted before October 2016.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted between 26 May 2016 and 15 June 2016.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The information is used for read across to Pseudo linalyl acetate.
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted 22 July 2010.
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
Animal Information:
Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Envigo RMS B.V., Inc., Horst, The Netherlands.
On receipt the animals were randomly allocated to cages.
The animals were nulliparous and non-pregnant.
After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
At the start of the study the animals were in the weight range of 15 to 23 g, and were 8 to 12 weeks old.

Animal Care and Husbandry:
The animals were housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
Free access to mains tap water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70%, respectively.
The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Based on the anticipated sensitization potential, three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 30% or 10% (v/v). A further group of five animals was treated with acetone/olive oil 4:1 alone.
No. of animals per dose:
Three groups, each of five animals per dose. A further group of five animals was treated with acetone/olive oil 4:1 alone.
Details on study design:
Test Item Preparation and Analysis
For the purpose of the study, the test item was used undiluted and freshly prepared as a solution in acetone/olive oil 4:1. This vehicle was chosen as it produced the most suitable formulation at the required concentration. The vehicle determination record is shown under 'Any other information on materials and methods incl. tables'. The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration. No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Preliminary Screening Test
As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test item, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µL of the undiluted test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Local skin irritation was scored daily according to the scale shown below:

Scale for Erythema (observation and score)
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema:2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4

Any clinical signs of toxicity, if present, were also recorded. The body weight was recorded on Day 1 (prior to dosing) and on Day 6. The thickness of each ear was measured using a Mitutoyo 547 300S gauge (Mitutoyo Corporation), pre dose on Day 1, post dose on Day 3 and on Day 6. Any changes in the ear thickness were noted. Mean ear thickness changes were calculated between time periods Days 1 and 3 and Days 1 and 6. A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitization.

Main Test
Test Item Administration
Based on the anticipated sensitization potential, groups of five mice were treated with the undiluted test item or the test item at concentrations of 30% or 10% (v/v) in acetone/olive oil 4:1. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of five mice received the vehicle alone in the same manner.

3H-Methyl Thymidine Administration
Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmoL, ARC UK Ltd) giving a total of 20 µCi to each mouse.

Observations
Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Body Weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).

Terminal Procedures
Termination: Five hours following the administration of 3HTdR all mice were killed by carbon dioxide asphyxiation followed by cervical separation. For each individual animal of each group the draining auricular lymph nodes were excised and processed. For each individual animal 1 mL of PBS was added to the lymph nodes.
Preparation of Single Cell Suspension: A single cell suspension of the lymph node cells for each individual animal was prepared by gentle mechanical disaggregation through a 200 mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish labeled with the study number and dose concentration. The lymph node cells suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The lymph node cells were pelleted at 1400 rpm (approximately 190 g) for 10 minutes. The pellet was re-suspended in 10 mL of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was re-suspended in 3 mL of 5% Trichloroacetic acid (TCA).
Determination of 3HTdR Incorporation: After approximately 18 hours incubation at approximately 4 °C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for 10 minutes, re-suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid. 3HTdR incorporation was measured by β-scintillation counting. The "Poly Q™" vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left to stand in darkness for approximately 20 minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately 20 minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system (Beckman Instruments Inc, Fullerton, CA, USA).

Data Evaluation
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitizer". The EC3 value was also calculated. The EC3 value is the concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation. The equation used for the calculation of EC3 is:

EC3 = c + [[(3-d)/(b-d)] x (a-c)]
a = lowest concentration giving stimulation index >3
b = actual stimulation index caused by ‘a’
c = highest concentration failing to produce a stimulation index of 3
d = actual stimulation index caused by ‘c’
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeneity of variance. If the assumptions that the data are both normally distributed and has homogeneity of variances, then parametric one way analysis of variance (ANOVA) and Dunnett’s multiple comparison procedure were used to determine statistical significance. If the assumptions were not met, non parametric Kruskal Wallis Rank Sum and Mann Whitney U test procedures were used. Probability values (p) are presented as follows:
P<0.001: ***
P<0.01: **
P<0.05: *
P≥0.05: (not significant)
Positive control results:
The strain of mouse used in these laboratories has been shown to produce satisfactory responses using known sensitizers and non sensitizers during the in house validation. The results of routine positive control studies are shown below:

Methods
Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of α-Hexylcinnamaldehyde, tech., 85% as a solution in acetone/olive oil 4:1 at concentrations of 5%, 10% or 25% (v/v). A further group of five animals was treated with acetone/olive oil 4:1 alone and served as the vehicle control group.

Results
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is shown under ‘Any other information on results incl. tables’. The concentration of α-Hexylcinnamaldehyde, tech., 85% expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 20%.

Conclusion
α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.
Key result
Parameter:
EC3
Value:
14
Remarks on result:
other: (%)
Parameter:
other: NOAEC
Value:
10
Remarks on result:
other: (%)
Parameter:
SI
Value:
2.11
Remarks on result:
other: 10%
Parameter:
SI
Value:
6.3
Remarks on result:
other: 30%
Parameter:
SI
Value:
5.42
Remarks on result:
other: 100%
Cellular proliferation data / Observations:
Preliminary Screening Test
Clinical observations, body weight and mortality data and local skin irritation is given under ‘Any other information on results incl. tables’. The ear thickness measurements and mean ear thickness changes are given ‘Any other information on results incl. tables’. No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. Based on this information, and anticipated sensitization potential, the undiluted test item and the test item at concentrations of 30% and 10% (v/v) in acetone/olive oil 4:1 were selected for the main test.

Main Test

Estimation of the Proliferative Response of Lymph Node Cells
The radioactive disintegrations per minute per lymph node and the stimulation index are given under ‘Any other information on results incl. tables’. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group is shown under ‘Any other information on results incl. tables’.

Clinical Observations and Mortality Data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Body Weight
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.

Calculation of EC3 Value
EC3 = c + [[(3-d)/(b-d)] x (a-c)]
a = 30
b = 6.30
c = 10
d = 2.11
The concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 14%.

Positive Control - The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:

Treatment

Stimulation Index

Result

5% v/v in acetone/olive oil 4:1

1.42

Negative

10% v/v in acetone/olive oil 4:1

1.53

Negative

25% v/v in acetone/olive oil 4:1

3.71

Positive

Clinical Observations, Body Weight and Mortality Data – Preliminary Screening Test

Concentration

Animal Number

Body Weight (g)

Day

1

2

3

4

5

6

Day 1

Day 6

Pre-Dose

Post Dose

Pre-Dose

Post Dose

Pre-Dose

Post Dose

100%

S-1

16.7

16.8

0

0

0

0

0

0

0

0

0

0 = No signs of systemic toxicity

Local Skin Irritation – Preliminary Screening Test

Concentration

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

100%

S-1

0

0

0

0

0

0

0

0

0

0

0

0

Measurement of Ear Thickness and Mean Ear Thickness Changes – Preliminary Screening Test

Concentration

Animal

Number

Ear Thickness Measurement (mm)

Day 1

Day 3

Day 6

pre‑dose

post dose

left

right

left

right

left

right

100%

S-1

0.23

0.22

0.19

0.19

0.20

0.20

overall mean (mm)

0.225

0.190

0.200

overall mean ear thickness change (%)

na

-15.556

-11.111

na = not applicable

Individual Disintegrations per Minute and Stimulation Index

Concentration
(% v/v) in
acetone/olive oil 4:1

Animal Number

dpm/
Animal
a

Mean dpm/Animal
(Standard Deviation)

Stimulation Indexb

Result

Vehicle

1-1

2020.72

1160.21
(±783.38)

na

na

1-2

544.30

1-3

313.74

1-4

993.55

1-5

1928.73

10

2-1

1247.66

2452.30
(±1201.90)

2.11

Negative

2-2

3133.40

2-3

3626.62

2-4

3192.85

2-5

1060.97

30

3-1

10815.27

7306.40**
(±4058.34)

6.30

Positive

3-2

2873.17

3-3

6728.17

3-4

12085.82

3-5

4029.59

100

4-1

9135.32

6282.68*
(±2209.78)

5.42

Positive

4-2

6617.93

4-3

7447.40

4-4

3630.30

4-5

4582.43

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

na = not applicable

** = Significantly different from control group p<0.01

* = Significantly different from control group p<0.05

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (%v/v) in
acetone/olive oil 4:1

Stimulation Index

Result

10

2.11

Negative

30

6.30

Positive

100

5.42

Positive

Interpretation of results:
other: Skin sensitiser Category 1B
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The test item was considered to be a sensitizer under the conditions of the test and resulted in an EC3 of 14%.
Executive summary:

The skin sensitization potential of the test substance has been tested according to OECD TG 429 (Local Lymph Node Assay) and GLP. Groups of five mice were treated with the undiluted test item (100%) or the test item at concentrations of 30% or 10% v/v in acetone/olive oil 4:1. At 10, 30 and 100% the substance showed an SI of 2.11, 6.30 and 5.42, respectively. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. 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. The concentration of the test item expected to cause a 3-fold increase in 3HTdR incorporation (EC3 value) was calculated to be 14%. A NOAEC of 10% is derived. Based on the results the substance needs to be classified as Cat. 1B according to EU CLP 1272/2008 and its amendments.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation potential for Pseudo Linalyl Acetate is derived from Myrcenyla acetate 'mono'. The executive summary of the source is presented below followed by the read-across rationale.

Myrcenyl acetate 'mono' experimental skin sensitisation information

The skin sensitization potential of the test substance has been tested according to OECD TG 429 (Local Lymph Node Assay) and GLP. Groups of five mice were treated with the undiluted test item (100%) or the test item at concentrations of 30% or 10% v/v in acetone/olive oil 4:1. At 10, 30 and 100% the substance showed an SI of 2.11, 6.30 and 5.42, respectively. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. 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. The concentration of the test item expected to cause a 3-fold increase in 3HTdR incorporation (EC3 value) was calculated to be 14%. A NOAEC of 10% is derived.

Skin sensitizing properties of Pseudo linalyl acetate using read across from Myrcenyl acetate (CAS 1118-39-4)

 

Introduction and hypothesis for the analogue approach

Pseudo linalyl acetate has one major, two minor constituents and a number of impurities. Myrcenyl acetate ‘mono’ with 25-35% is the main constituent. Alpha and Gamma Terpinlyl acetate are the minor ones, each between 10-20%. For Pseudo linalyl acetate no skin sensitisation information is available.In accordance with Article 13 of REACH, lacking information can be generated by other means, i.e. applying alternative methods such as QSARs, grouping and read-across. For assessing the skin sensitizing properties of Pseudo linalyl acetate the analogue approach is selected because for one its major constituent skin sensitizing properties is available which can be used for read across.

Hypothesis: Pseudo linalyl acetate has the same skin sensitizing properties as Myrcenyl acetate ‘mono’.

Available information: The skin sensitization potential of Myrcenyl acetate ‘mono’ has been tested according to OECD TG 429 (Local Lymph Node Assay) and GLP. The concentration of the test item causing a 3-fold increase in 3HTdR incorporation (EC3 value) was calculated to be 14%.

Target chemical and source chemical(s)

Chemical structures of the target chemical and the source chemical(s) are shown in the data matrix, including physico-chemical properties and available toxicologicalinformation.

Purity / Impurities

Pseudo linalyl acetate’s key constituents are covered by Myrcenyl acetate ‘mono’. All impurities (< 10%) are not expected to impact the assessment and are presented in Appendix 1.

Analogue approach justification

According to Annex XI 1.5 read across can be used to replace testing when the similarity can be based on a common backbone and a common functional group. When using read across the result derived should be applicable for C&L and/or risk assessment and it should be presented with adequate and reliable documentation, which is presented below.

Analogue selection: For Pseudo linalyl acetate the major constituent Myrcenyl acetate ‘mono’ has been selected as an analogue for which a LLNA information is available. The result from this test is expected to present a conservative EC3.

Structural similarities and differences: The constituents of Pseudo linalyl acetate are branched or cyclic, saturated and non-saturated hydrocarbons to which acetic esters are attached. Myrcenyl acetate ‘mono’ has a conjugated double bond at the end of its alkyl chain and has a tertiary ester at the other end. The conjugated double bond is the most electrophilic and reactive site when compared to singe unsaturated bonds such as the Terpinyl acetates.

Dermal bioavailability: The dermal absorption of Pseudo linalyl acetate and Myrcenyl acetate ‘mono’ are similar because the constituents including Myrcenyl acetate have the same molecular weight (196) and a log Kow of around 4.4.

Skin sensitisation reactivity: For skin sensitisation conjugated double bonds are electrophilic fragments are these are more reactive and have lower EC3 compared to single unsaturated bonds. Also esters are more reactive compared to alcohols (present as impurities). Therefore Myrcenyl acetate ‘mono’ is a conservative representative for the skin sensitisation. This is supported with the information from Alpha-Terpinyl acetate, which is not a skin sensitiser.

Uncertainty of the prediction: There are no other uncertainties than already discussed above.

Data matrix

The relevant information on physico-chemical properties and toxicological characteristics are presented in the Data Matrix.

Conclusions on skin sensitisation for hazard and risk assessment

For Pseudo linalyl acetate no skin sensitisation information is available, but for one of its major constituents there is such information. When using read across the result derived should be applied for C&L and/or risk assessment and be presented with adequate and reliable documentation and is documented above. For Myrcenyl acetate ‘mono’ an LLNA test is available (Reliability 1) in which an EC3 of 14% is derived, which can be used for read across to Pseudo linalyl acetate.

Final conclusion:Pseudo linalyl acetate is concluded to have an EC3 of 14% is therefore a skin sensitizer 1B.

 

Data matrix to support the read across to Pseudo linalyl acetate from Myrcenyl acetate 'mono'.

Common name

Pseudo linalyl acetate

Myrcenyl acetate ‘mono’

Alpha-Terpinyl acetate

Gamma-Terpinyl acetate

 

Target

Source

Supporting Source

Minor constituent

Structure

Reaction mass

 

CAS #

Not applicable

1118-39-4

80-26-2

10235-63-9

EC #

944-488-2

214-262-0

201-265-7

233-564-3

REACH registration

2018

2018

Registered

Not found

Empirical formula

Not applicable

C12H20O2

C12H20O2

C12H20O2

Molecular weight

Not applicable

196

196

196.29

Physico-chemical data

 

 

EpiSuite

EpiSuite

Log Kow

4.4 (exp.)

4.4 (exp.)

4.3

4.5

Human health endpoints

 

 

 

 

Skin sensitisation

 

Skin sensitiser1B

Based on read-across

Skin sensitiser1B

(LLNA, OECD TG 429)

Not a skin sensitiser

(LLNA, OECD TG 429)

No information available

 

 

Appendix 1: Constituents and possible impurities of Pseudo linalyl acetate

CAS#

Type of constituent

Type and Name

 

 

Esters linear and alicyclic

1118-39-4

Major

2-methyl-6-methylideneoct-7-en-2-yl acetate (Myrcenyl acetate ‘mono’)

7643-61-0

Impurity

(5Z)-2,6-dimethylocta-5,7-dien-2-yl acetate

7643-62-1

Impurity

(5Z)-2,6-dimethylocta-5,7-dien-2-yl acetate

105-87-3 *

Impurity

(2E)-3,7-dimethylocta-2,6-dien-1-yl acetate (Geranyl acetate)

80-26-2 *

Minor

2-(4-methylcyclohex-3-en-1-yl)propan-2-yl acetate (Alpha-Terpinyl acetate)

150461-96-4

Impurity

1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate

150461-97-5

Impurity

1-(5,5-dimethylcyclohex-1-en-1-yl)ethyl acetate

10235-63-9

Minor

1-methyl-4-(propan-2-ylidene) cyclohexyl acetate (Gamma-Terpinyl acetate)

20777-47-3

Impurity

cis-1-methyl-4-(prop-1-en-2-yl)cyclohexyl acetate (Beta-terpinyl acetate)

97890-05-6

Impurity

(2Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate

76-49-3

Impurity

(1R,2S,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-ylrel-acetate (Bornyl acetate)

210648-12-7

Impurity

3,3,5-trimethylcyclohept-4-en-1-yl acetate

 

 

Alcohol linear and alicyclic

543-39-5

Impurity

2-methyl-6-methylideneoct-7-en-2-ol (Myrcenol)

98-55-5 *

Impurity

2-(4-methylcyclohex-3-en-1-yl)propan-2-ol (Alpha-Terpineol)

586-81-2

Impurity

1-methyl-4-(propan-2-ylidene)cyclohexanol (Gamma-terpineol)

 

Justification for classification or non-classification

Based on the results, the substance needs to be classified as Skin sensitizer Category 1B, and shall be labelled as 'H317: May cause an allergic skin reaction', according to EU CLP (EC No. 1272/2008 and its amendments).