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Diss Factsheets

Administrative data

Description of key information

Weight of evidence: Based on the read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate (open epicutaneous test, no data on GLP), 2-methylcyclohexyl acetate was determined to be not sensitizing to the skin.

Weight of evidence: Based on the read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate (Buehler test, no data on GLP), 2-methylcyclohexyl acetate was determined to be not sensitizing to the skin.

Weight of evidence: Based on the read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate (Freund's complete adjuvant test, no data on GLP), 2-methylcyclohexyl acetate was determined to be not sensitizing to the skin.

Weight of evidence: Based on the read-across approach from experimental results on analogue d-Cyclocitronellene acetate (guinea pig maximization test, no data on GLP), 2-methylcyclohexyl acetate was determined to be not sensitizing to the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
(no data on controls)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study, performed before OECD guidelines were available for LLNA method. The study is appropiate to assess the sensitising characteristics of the test item.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Route:
intradermal and epicutaneous
Vehicle:
other: liquid paraffin
Concentration / amount:
10% (intradermal) and 100% (epicutaneous)
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin
Concentration / amount:
10% and 20%.
No. of animals per dose:
Total: 30 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE: Induction consisted of two stages, intradermal injection followed one week later by occluded patch application.
INTRADERMAL:
- No. of exposures: 6 injections (2 per test groups)
- Test groups: Freund's complete adjuvant (FCA), test material in liquid paraffin and test material in FCA.
- Duration: 1 weeks
- Concentrations: 0 % (only FCA), 10% in vehicle (liquid paraffin) and 10% in FCA. 0.1 ml each.
EPICUTANEOUS:
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: Test material
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after topical induction (day 21).
- Test groups: test material
- Concentrations: 10% and 20%
- Evaluation (hr after challenge): 24h, 48h and 72h after patch removal
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
30
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
30
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
30
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
30
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
30
Reading:
other: 3rd
Hours after challenge:
72
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
30

No sensitization reactions were observed either in control groups.

Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Under the experimental conditions applied, d-cyclocitronellene acetate was considered not sensitizer.
Executive summary:

A guinea pig maximization test was conducted with thirty male Hartley Dunkin albino guinea pigs. Induction consisted of two stages, intradermal injection followed one week later by a 48 h occluded patch application. A total of 6 intradermal injections were administered. They comprised: 2 injections of 0.1 ml of 50% Freund’s complete adjuvant (FCA), 2 injections of 0.1 ml of a 10% solution of the test material in liquid paraffin; 2 injections of 0.1 ml of a 10% suspension of the test material in FCA (1:1). The topical induction concentration was 100%. Fourteen days after topical induction animals were challenged with 10 and 20% test material in liquid paraffin. The treatment sites were examined for evidence of sensitization 24, 48 and 72 h after patch removal. No sensitization reactions were observed.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
Existing study, performed before OECD guidelines were available for LLNA method. The study is appropiate to assess the sensitising characteristics of the test item.
Species:
guinea pig
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: diethyl phtalate
Remarks:
0%
Concentration / amount:
10%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: diethyl phtalate
Remarks:
0%
Concentration / amount:
10%
No. of animals per dose:
Test group: 20 animals per dose
Control group: 10 animals per dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE:
- No. of exposures: 3
- Exposure period: 6h each
- Test groups: Test item (1 group, 20 animals)
- Control group: Vehicle only (1 group, 10 animals)
- Frequency of applications: once a week
- Duration: three weeks
- Concentrations: 0% (control, vehicle), 10%

B. CHALLENGE EXPOSURE:
- No. of exposures: 2 (duplicate challenge closed patches were applied to the original site and to fresh sites on the opposite flank of each animal)
- Day(s) of challenge: two weeks after the third exposure
- Exposure period: 24h
- Test groups: Test item (1 group, 20 animals)
- Control group: Test item (1 group, 10 animals)
- Site: original site of induction and fresh site on the opposite flank
- Concentrations: 10%
- Evaluation (hr after challenge): 24, 48 and 72 after removal
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

No sensitization reactions were observed.

Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Under the experimental conditions applied, 2-(1-methylpropyl)-1-vinylcyclohexyl acetate was considered not sensitizer.
Executive summary:

A Buehler sensitization test was conducted on 20 guinea pigs. A control group of 10 animals received only the vehicle. During the induction phase each animal received three closed patch applications of 10% test material in diethyl phthalate. Two weeks after the third exposure, duplicate challenge closed patches were applied to the original site and to fresh sites on the opposite flank of each animal. The patches were kept in place for 24 h and the reactions were graded 24, 48 and 72 h after removal. No sensitization reactions were observed.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
GLP compliance:
no
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
Existing study, performed before OECD guidelines were available for LLNA method. The study is appropiate to assess the sensitising characteristics of the test item.
Species:
guinea pig
Sex:
not specified
Route:
intradermal
Vehicle:
no data
Concentration / amount:
5% in Freund's complete adjuvant (FCA) (0.1 ml)
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
3 and 10% (0.025 ml)
No. of animals per dose:
8 animals per dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Test groups: 5% test item in FCA
- Control group: FCA only
- Frequency of applications: day 0, 2, 4, 7 and 9
- Duration: 9 days
- Concentrations: 5% in FCA (0.1 ml) (total dose approximately 250 mg during the induction exposure)

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 and 35
- Test groups: Test item
- Control group: Test item
- Concentrations: 3 and 10%
- Evaluation (hr after challenge): 24, 48 and 72 h.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8

No sensitization reactions were observed in control groups.

Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Under the experimental conditions applied, 2-(1-methylpropyl)-1-vinylcyclohexyl acetate was considered not sensitizer.
Executive summary:

Sensitization was determined following intradermal test with Freund’s complete adjuvant (FCAT) conducted on 8 guinea pigs per group. A control group of animals was also used. Induction consisted of five intradermal injections of a 0.1 ml of a 5% test material in Freund’s complete adjuvant (FCA) injected on days 0, 2, 4, 7 and 9 (total dose approximately 250 mg). Animals were challenged epicutaneously on days 21 and 35 with 0.025 ml of 3 or 10% test material applied to the skin areas measuring 2 cm2. Reactions were read after 24, 48 and 72 h. No sensitization was observed.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
(no data on controls)
Principles of method if other than guideline:
Scientific review (peer-reviewed by expert panel).
GLP compliance:
no
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Existing study, performed before OECD guidelines were available for LLNA method. The study is appropiate to assess the sensitising characteristics of the test item.
Species:
guinea pig
Sex:
not specified
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
3, 10, 30 and 100% (0.1 ml)
Route:
epicutaneous, open
Vehicle:
other: ethanol
Concentration / amount:
10% (0.1 ml)
No. of animals per dose:
6 animals per group.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Exposure period: Continuous
- Test groups: Test item (4 groups)
- Site: 8 cm2 of the clipped flanks
- Frequency of applications: daily
- Concentrations: 0.1 ml of test material at 3, 10, 30 and 100% in ethanol

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: days 21 and 35 (re-challenge)
- Test groups: Test item (4 groups)
- Site: 8 cm2 of the clipped flanks
- Concentrations: 10% of test material in ethanol
- Evaluation (hr after challenge): 24, 48 and/or 72 h
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24

No sensitization reactions were observed.

Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Under the experimental conditions applied, 2-(1-methylpropyl)-1-vinylcyclohexyl acetate was considered not sensitizer.
Executive summary:

An open epicutaneous test (OET) was conducted on four groups of 6 guinea pigs. During the induction phase of the study, 0.1 ml of test material at 3, 10, 30 and 100% in ethanol was applied daily for 21 consecutive days to the clipped flanks of each animal (8 cm2 area) and left uncovered. A challenge application, 10% in ethanol, was performed on day 21 and day 35 of the study. Reactions were read after 24, 48 and/or 72 h. No sensitization reactions were observed.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
See attached the reporting format and read-across rationale.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
30
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
30
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
30
Remarks on result:
other: based on a read-across from an analogue substance
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
30
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
30
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
30
Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Based on the read-across approach from experimental results on analogue d-Cyclocitronellene acetate, 2-methylcyclohexyl acetate was determined to be not sensitising to the skin.
Executive summary:

A guinea pig maximization test was conducted on the analogue substance d-Cyclocitronellene acetate in 30 male Hartley Dunkin albino guinea pigs. Induction phase consisted of intradermal injection (0.1 ml of FCA, 0.1 ml of 10% test item in vehicle and 0.1 ml of 10% test item in FCA) followed one week later by 48 h occluded patch application (100% test item). Fourteen days after, animals were challenged with 10 and 20% test item in liquid paraffin. No sensitization reactions were observed at 24, 48 and 72 hours after removal. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
See attached the reporting format and read-across rationale.

Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: based on a read-across from an analogue substance
Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Based on the read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate, 2-methylcyclohexyl acetate was determined to be not sensitising to the skin.
Executive summary:

An open epicutaneous test (OET) was conducted on the analogue substance 2-(1-methylpropyl)-1-vinylcyclohexyl acetate. 6 guinea pigs per group were exposed to 0.1 ml of test material at 3, 10, 30 and 100% in ethanol daily during 21 days of the induction phase. A challenge application of 10 % in ethanol was performed on day 21 and day 35 of the study. No sensitization reactions were observed at 24, 48 and/or 72 h after reaction. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Based on the metabolic fate and OECD QSAR Application Toolbox, where the substances share analogue structural alerts (see attached rationale), the toxicity values of 2-(1-methylpropyl)-1-vinylcyclohexyl acetate and 2-methylcyclohexyl acetate are comparable.
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
See attached the reporting format and read-across rationale.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: based on a read-across from an analogue substance
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Based on the read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate, 2-methylcyclohexyl acetate was determined to be not sensitising to the skin.
Executive summary:

A Buehler sensitization test was conducted on the analogue substance 2-(1-methylpropyl)-1-vinylcyclohexyl acetate. During the induction phase, 20 guinea pigs were exposed to 3 applications of 10% test material in diethyl phthalate. Two weeks after, challenge closed patches were applied. No sensitization reactions were observed at 24, 48 and 72 h after removal. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
See attached the reporting format and read-across rationale.
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: based on a read-across from an analogue substance
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: based on a read-across from an analogue substance
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Interpretation of results:
GHS criteria not met
Remarks:
EU Criteria
Conclusions:
Based on the read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate, 2-methylcyclohexyl acetate was determined to be not sensitising to the skin.
Executive summary:

A Freund's complete adjuvant test (FCAT) was conducted on the analogue substance 2-(1-methylpropyl)-1-vinylcyclohexyl acetate. During the induction phase, 8 guinea pigs per group were exposed to 5 intradermal injections of 0.1 ml of 5% test material in FCA. Animals were challenged epicutaneously with 0.025 ml of 3 and 10% test material in each group. No sensitization was observed at 24, 48 and 72 h after exposure. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization: Read-across approach from experimental results on analogue 2-(1-methylpropyl)-1-vinylcyclohexyl acetate (see details on Rationale for read-across approach attached in Section 13):

Weight of evidence: An open epicutaneous test (OET) was conducted on the analogue substance 2-(1-methylpropyl)-1-vinylcyclohexyl acetate. 6 guinea pigs per group were exposed to 0.1 ml of test material at 3, 10, 30 and 100% in ethanol daily during 21 days of the induction phase. A challenge application of 10 % in ethanol was performed on day 21 and day 35 of the study. No sensitization reactions were observed at 24, 48 and/or 72 h after reaction. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Weight of evidence: A Buehler sensitization test was conducted on the analogue substance 2-(1-methylpropyl)-1-vinylcyclohexyl acetate. During the induction phase, 20 guinea pigs were exposed to 3 applications of 10% test material in diethyl phthalate. Two weeks after, challenge closed patches were applied. No sensitization reactions were observed at 24, 48 and 72 h after removal. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Weight of evidence: A Freund's complete adjuvant test (FCAT) was conducted on the analogue substance 2-(1-methylpropyl)-1-vinylcyclohexyl acetate. During the induction phase, 8 guinea pigs per group were exposed to 5 intradermal injections of 0.1 ml of 5% test material in FCA. Animals were challenged epicutaneously with 0.025 ml of 3 and 10% test material in each group. No sensitization was observed at 24, 48 and 72 h after exposure. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Weight of evidence: A guinea pig maximization test was conducted on the analogue substance d-Cyclocitronellene acetate in 30 male Hartley Dunkin albino guinea pigs. Induction phase consisted of intradermal injection (0.1 ml of FCA, 0.1 ml of 10% test item in vehicle and 0.1 ml of 10% test item in FCA) followed one week later by 48 h occluded patch application (100% test item). Fourteen days after, animals were challenged with 10 and 20% test item in liquid paraffin. No sensitization reactions were observed at 24, 48 and 72 hours after removal. Based on these results, the read-across approach was applied and 2 -methylcyclohexyl acetate was determined to be not sensitising to the skin.

Justification for classification or non-classification

Based on the available data, 2 -methylcyclohexyl acetate is not classified for skin sensitization in accordance with CLP Regulation (EC) no 1272/2008.