Registration Dossier
Registration Dossier
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EC number: 264-598-7 | CAS number: 64001-15-6
Endpoint summary
Administrative data
Description of key information
Skin corrosion: The substance is not corrosive based on the absence of skin irritation.
Skin irritation: The substance is not a skin irritant, using read across from Cyclacet (OECD TG 404)
Eye irritation: The substance is not an eye irritant using read across from Cyclacet (OECD TG 405)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- The in vivo skin irritation test is performed before the REACH regulation came into force requesting in vitro studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02-11-1976 - 13-12-1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted similar to OECD Test Guideline No. 404, but not under GLP Standards.
- Justification for type of information:
- Information used to read across to Cyclacet Dihydro.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 10 animals used; different scoring system; observation < 14 days (Reversibility check); positve and negative control substances used.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
Controls:
Positve control: Cyclamen Aldehyde
Negative control: Diethyl Phthalate - Duration of treatment / exposure:
- 4 hours
- Observation period:
- at 4, 24, 48 and 72 hours
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- % coverage: no data
- Type of wrap if used: Patches are prepared by heat-sealing 1" x 1" 24 ply gauze pads on to 1 1/4" x 1 1/4" squares of polythene sheeting which is then attached to 3 1/2" x 1" strips of adhesive tape. Test solutions are applied to a dry patch. The patches are firmly attached to ensure good contact between the skin and test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean
- Time after start of exposure:4 hours
SCORING SYSTEM: The sites are scored for erythema, oedema, cracking and scaling and any other feature using an 8-point anchored ordinate scale ranging from “a” (very slight) to “h” (severe). At the end of the test the reaction grades are converted to corresponding numerical scores which are used to calculate the total irritation score per animal, an overall score per treatment group, a mean irritation score per site, and a mean irritation score per site per day for each treatment group. A mean irritation ranking for each treatment group is also given.
Reaction Grades and Scores of erythema, oedema, cracking and scaling:
a marginal/very slight = 1
b slight = 2
c fairly distinct =3
d quite distinct = 4
e becoming well developed = 6
f well developed = 8
g becoming severe = 10
h severe = 12
STATISTICS:
The Wilcoxon Matched-Pairs Signed Ranks Test, which considers the size and direction of differences between reactions is used to test the significance of differences between pairs of treatment groups. - Irritation parameter:
- other: mean irritation ranking
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.1
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Overall Irritation Score: 23900
Mean Score per Site: 23.90
Mean Score per Site per Day: 5.97
Mean irritation ranking: 3.1
The maximum score is a very estimated value, except for the last value: the mean score per site per day. - Other effects:
- no data
- Interpretation of results:
- other: not irritating
- Remarks:
- according to the EU CLP Regulation 1272/2008 and its amendments
- Conclusions:
- In a Rabbit Covered Patch Skin Irritation Test, single 4-hour-exposure of Jasmacyclene (crude), under semi-occlusive conditions, caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. No classification and labelling is required based on these results.
- Executive summary:
The skin irritation/corrosion potential of Cyclacet was investigated in a study similar to OECD Test Guideline 404 (Acute Dermal Irritation / Corrosion). In this Rabbit Covered Patch Skin Irritation Test, single 4 -hour-exposure of Cyclacet under semi-occlusive conditions caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. This does not result in the substance being a skin irritant.
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The information is derived from read across.
- Justification for type of information:
- The information for Cyclacet Dihydro is derived from Cyclacet. The information is based on the analogue Cyclacet. The justification is presented in the Endpoint summary and includes also eye irritation. The accompanying file is also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Other effects / acceptance of results:
- In vivo information is available before the Reach Regulation came into force requesting in vitro studies.
- Irritation parameter:
- other: mean irritation ranking
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.1
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Overall Irritation Score: 23900
Mean Score per Site: 23.90
Mean Score per Site per Day: 5.97
Mean irritation ranking: 3.1
The maximum score is a very estimated score. - Interpretation of results:
- other: not irritating
- Remarks:
- according to the EU CLP Regulation 1272/2008 and its amendments
- Conclusions:
- The substance is not a skin irritant.
Referenceopen allclose all
Under the conditions of this test Jasmacyclene (crude) produced slight to moderate irritation consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. The test substance was significantly more irritant than the negative control, diethyl phthalate, which produced only a marginal response. The test ingredient was significantly less irritant than the positive control, cyclamen aldehyde, which produced well-developed erythema fairly distinct cracking and slight scaling.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-05-1977 - 31-05-1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted similar to OECD Test Guideline No. 405, but not under GLP Standards.
- Justification for type of information:
- The information is used to read across to Cyclacet Dihydro.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- different scoring system
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Modified Federal Hazardous Substances Labelling Act Method
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 9 weeks
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- at 15 min., 1, 2, and 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
-
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Remarks:
- swelling in %
- Basis:
- animal #1
- Time point:
- other: 1 day
- Score:
- 45
- Max. score:
- 45
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: swelling is in percentage
- Irritation parameter:
- cornea opacity score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- other: 1, 2 and 3 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- other: 1, 2 and 3 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: erythema
- Basis:
- animal #1
- Time point:
- other: 1 day
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: erythema
- Basis:
- animal #2
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: erythema
- Basis:
- animal #3
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 day
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2-days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Jasmacyclene Crude caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
- Interpretation of results:
- other: not an eye irritant
- Remarks:
- according to EU CLP (1272/2008 and its amendments)
- Conclusions:
- Cyclacet (in report Jasmacyclene Crude) is slightly irritant to eyes and may cause a stinging sensation if splashed into the eyes, but does not warrant classification and labelling).
- Executive summary:
The primary eye irritation potential of Cyclacet was investigated in a study similar to OECD Test Guideline 405 (Acute Eye Irritation / Corrosion).
A single administration of Cyclacet in the eye of 3 rabbits caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
It is concluded that Cyclacet is slightly irritant to eyes and may cause a stinging sensation if splashed into the eyes. According to the Modified Federal Hazardous Substances Labelling Act Method a slight irritating potential of the test compound has been found. However, the findings result in absence of eye irritation.
- Endpoint:
- eye irritation, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The information is retrieved from read across infiormation.
- Justification for type of information:
- The information is based on the analogue Cyclacet. The justification is presented in the Endpoint summary and includes also skin irritation. The accompanying file is also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Number of animals or in vitro replicates:
- 3
- Details on study design:
-
TOOL USED TO ASSESS SCORE: hand-slit lamp - Other effects / acceptance of results:
- The information is retrieved from read across, therefore the in vitro results cannot be filled.
- Irritation parameter:
- cornea opacity score
- Remarks:
- swelling in %
- Basis:
- animal #1
- Time point:
- other: 1 day
- Score:
- 45
- Max. score:
- 45
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: swelling is in percentage
- Irritation parameter:
- cornea opacity score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- other: 1, 2 and 3 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- other: 1, 2 and 3 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: erythema
- Basis:
- animal #1
- Time point:
- other: 1 day
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: erythema
- Basis:
- animal #2
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: erythema
- Basis:
- animal #3
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 day
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2-days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Cyclacet (in report Jasmacyclene Crude) caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
- Interpretation of results:
- other: not eye irritating
- Remarks:
- according to the EU CLP Regulation 1272/2008
- Conclusions:
- The substance is not an eye irritant.
Referenceopen allclose all
A single administration of Cyclacet in the eye of 3 rabbits caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
A single administration of Cyclacet in the eye of 3 rabbits caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
For Cyclacet Dihydro skin and eye irritation is derived by read across from Cyclacet. First the executive summaries of the skin and eye irritation information are presented and thereafter the full read across
Skin irritation from Cyclacet
The skin irritation/corrosion potential of Cyclacet was investigated in a study similar to OECD Test Guideline 404 (Acute Dermal Irritation / Corrosion). In this Rabbit Covered Patch Skin Irritation Test, single 4 -hour-exposure of Cyclacet under semi-occlusive conditions caused slight to moderate irritation, consisting of marginal to slight erythema and oedema with variable cracking and scaling ranging from slight to distinct. This does not result in the substance being a skin irritant.
Eye irritation from Cyclacet
The primary eye irritation potential of Cyclacet was investigated in a study similar to OECD Test Guideline 405 (Acute Eye Irritation / Corrosion).
A single administration of Cyclacet in the eye of 3 rabbits caused slight corneal lesions affecting up to half of the corneal surface in two animals. One of these lesions was associated with moderate corneal swelling, slight conjunctivitis and discharge. The lesions had healed within three days. The remaining animal was unaffected. One animal showed signs of discomfort when treated.
It is concluded that Cyclacet is slightly irritant to eyes and may cause a stinging sensation if splashed into the eyes. According to the Modified Federal Hazardous Substances Labelling Act Method a slight irritating potential of the test compound has been found. However, the findingsresult in absence of eye irritation.
The irritation properties of Cyclacet Dihydro are derived from Cyclacet and the justification is presented below.
Cyclacet Dihydro (Cas no 64001-15-6)and its irritation potential derived from Cyclacet (Cas no generic 54830-99-8)
Introduction
Cyclacet Dihydro has atricyclodecanyl -fused ring structure to which an acetic-ester is attached (See Data matrix). For this substance no skin and eye irritation information is available. In accordance with Article 13 of REACH, lacking information can be generated by means of applying alternative methods such as in vitro, QSARs, grouping and read-across. For Cyclacet Dihydro the skin and eye irritation will be derived from Cyclacet.
Hypothesis: Cyclacet Dihydro will have the same skin and eye irritation as Cyclacet in view of high similarity in structure considering backbone and functional group, resulting in the same absence of skin and eye irritation.
Available information on skin and eye irritation:Cyclacet has been tested in rabbits according to OECD TG 404 and 405, respectively under GLP and receiving Klimisch 1 for reliability.
Target chemical and source chemical(s)
Chemical structures of the target chemical and the source chemical are shown in the data matrix.
Purity / Impurities
The purity and impurities of the target chemical do not indicate other constituents or impurities (all< 10%) that indicated a different irritation potential.
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.
In accordance with ECHA guidance (2017, RAAF) Cyclacet is selected as the key source because of the similarities in structure of both substances considering backbone and functional group.
Structural similarities and differences:Cyclacet Dihydro, the target, and the source chemical Cyclacet have identical structural features consisting of a tricyclodecan-e/yl fused ring structure and an acetic ester attached at the bridged hexyl ring. The difference is that Cyclacet Dihydro (as presented in the name) does not have a double bond in the pentyl -ring which Cyclacet has.
Toxico-kinetics: For skin and eye irritation absorption through the outer layers is important for reaching the living cells underneath, when the substance is not corrosive.Absorption: The molecular weights, appearance, physico-chemical properties all indicate a similar bioavailability.
Toxico-dynamic-reactivity:Cyclacet Dihydro and Cyclacet are anticipated to have similar reactivity because they have almost the same structure. The absence of the double bond in the pentyl-ring of Cyclacet Dihydro indicates a somewhat lower electrophilicity and therefore a lower reactivity if any when compared to Cyclacet. Both substances have the acetic ester as the functional group further supporting the similarity in reactivity.
Uncertainty: There is no uncertainty in the prediction based on the same functional group and very similar backbone. In accordance with ECHA guidance (RAAF, 2017) the read across receives score 5.
Data matrix
The Data matrix is presented in Table 1, below.
Conclusions for skin and eye irritation and on classification and labelling
Skin irritation:The skin irritation potential of Cyclacet Dihydro is derived from Cyclacet. Cyclacet does not need to be classified as a skin irritant and therefore Cyclacet Dihydro is not a skin irritant either.
Eye irritant: The eye irritation potential of Cyclacet Dihydro is derived from Cyclacet. Cyclacet does not need to be classified as a skin irritant and therefore Cyclacet Dihydro does not need to be classified as an eye irritant.
Classification and Labelling: Cyclacet Dihydro has no skin and eye irritation potential and therefore the substance does not need to be classified and labelled according to EU CLP (EC 1272/2008 and its amendments).
Table 1: Data matrix presenting the characteristics of Cyclacet Dihydro and its source Cyclacet to support the read across for skin irritation and eye irritation
Common names |
Cyclacet Dihydro |
Cyclacet |
Chemical structures |
||
|
Target |
Source |
Cas no of the main isomer Cas no of the generic |
64001-15-6 |
2500-83-6 (5-yl) 54830-99-8 |
Einecs |
264-598-7 |
911-369-0 |
REACH registration |
REACH registered for 2018 |
REACH registered |
Empirical formula |
C12H18O2 |
C12H16O2 |
Smiles |
CC(=O)OC3CC1CC3C2CCCC12 |
CC(=O)OC3CC1CC3C2CC=CC12 |
Physico-chemical data |
|
|
Molecular weight |
194 |
192 |
Physical state |
liquid |
liquid |
Vapour pressure Pa (measured) |
2.2 |
2.1 |
Water solubility mg/l (measured) |
89 |
186 |
Log Kow (measured) |
4.5 |
3.9 |
Log Kow (calculated – ECOSAR) |
3.1 |
2.85 |
Human health |
|
|
Skin irritation |
Read across from Cyclacet |
Not a skin irritant (OECD TG 404)
|
Eye irritation |
Read across from Cyclacet |
Not an eye irritant (OECD TG 405) |
Justification for classification or non-classification
Based on the information provided Cyclacet Dihydro is not a skin or eye irritant according to EU CLP 1272/2008 and its amendments.
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.
