Registration Dossier

Administrative data

Description of key information

Skin irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

Skin irritation study of read across chemical was conducted by peer reviewed journal on human subjects to determine the degree of skin irritancy caused by the chemical. Each subject was treated with 4% of test chemical in petrolatum dermally for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of human subjects.

 

The above result was supported by another skin study on female volunteers for another similar read across substance. During the test, approximately 4% of chemical was applied onto the forearm or back of each volunteer in petrolatum for 48 hours under occlusive condition. The chemical failed to cause skin irritation. Hence the chemical was considered as not irritating to the skin.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

An ocular irritation study was conducted by authoritative database for similar read across chemical on New Zealand rabbits. The purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits. The study was performed according to a modification of the method as described in the Code of Federal Regulations, section 1500.42 Guidelines. 6 New Zealand albino rabbits were used for the study. About 0.1ml undiluted test chemical was instilled in the left eye of the rabbits, while the right eye remained untreated and served as control. The treated eyes remained unwashed throughout the study. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material. Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four. The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits. Based on the scores and observations, the test substance was considered to be not irritating to rabbit eyes.

 

The above result was further supported by an eye irritation study reported by safety assessment report on rabbits for another read across chemical according to OECD 405 Guidelines. In this test, rabbits were exposed to the test chemical for 24 hours and observed for signs of irritation. The eyes showed signs of reversible redness and swelling of the conjunctiva, which, according to Directive 83/467 / EEC, should not be considered as irritating. Hence, the test material was considered to be not irritating to rabbit eyes.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on 2 skin irritation studies as- WoE-2 and WoE-3.
Skin irritation study of test chemical was conducted on humans to assess its skin irritating effects.
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
Name: (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one
InChI:1S/C15H24O/c1-13(2)7-6-11(16)12-14(3,4)10-5-8-15(12,13)9-10/h10,12H,5-9H2,1-4H3/t10-,12+,15-/m0/s1
Smiles:CC1(C)[C@H]2CC[C@]3(C2)[C@@H]1C(=O)CCC3(C)C
Molecular Formula: C15H24O
Molecular Weight: 220.3536 g/mole
Species:
other: Human
Strain:
other: Not applicable
Details on test animals and environmental conditions:
No data available
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Petrolatum
Controls:
not specified
Amount / concentration applied:
4%
Duration of treatment / exposure:
48 hours
Observation period:
48 hours
Number of animals:
No Data Available
Details on study design:
No Data Available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not fully reversible within:
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No known signs of skin irritation were observed.
Interpretation of results:
other: Not irritating
Conclusions:
The test material (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) was considered to be not irritating to the skin of human subjects.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

Skin irritation study of read across chemical was conducted by peer reviewed journal on human subjects to determine the degree of skin irritancy caused by the chemical. Each subject was treated with 4% of test chemical in petrolatum dermally for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of human subjects.

 

The above result was supported by another skin study on female volunteers for another similar read across substance. During the test, approximately 4% of chemical was applied onto the forearm or back of each volunteer in petrolatum for 48 hours under occlusive condition. The chemical failed to cause skin irritation. Hence the chemical was considered as not irritating to the skin.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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:
data from handbook or collection of data
Remarks:
experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on 2 eye irritation studies as- WoE-2 and WoE-3.
An eye irritation study of test chemical was conducted on rabbits to assess its eye irritating effects.
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
Name: (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one
InChI:1S/C15H24O/c1-13(2)7-6-11(16)12-14(3,4)10-5-8-15(12,13)9-10/h10,12H,5-9H2,1-4H3/t10-,12+,15-/m0/s1
Smiles:CC1(C)[C@H]2CC[C@]3(C2)[C@@H]1C(=O)CCC3(C)C
Molecular Formula: C15H24O
Molecular Weight: 220.3536 g/mole
Species:
rabbit
Strain:
other: 1.New Zealand White 2.not specified
Details on test animals or tissues and environmental conditions:
1.Housing: The animals were housed individually
Diet: The animals were housed and fed individually and maintained in accordance with standard laboratory procedure.
Water: Water was available at all times

2.not specified
Vehicle:
other: 1. unchanged (no vehicle) 2.not specified
Controls:
yes
Amount / concentration applied:
1.0.1ml
2.not specified
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1.The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material
2.not specified
Number of animals or in vitro replicates:
1.6
2.not specified
Details on study design:
1.Details on study design
TEST SITE
- Area of exposure: left eye conjunctival sac

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

Observation duration: The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material.

SCORING SYSTEM:
SCALE FOR INTERPRETATION OF EYE SCORES FOR OCULAR LESIONS (DRAIZE)

1. Cornea
Total Maximum = 80
2. Iris
Total Maximum = 10
3. Conjunctivae
Total Maximum = 20
Total Eye Score = 110

Classification of ocular reactions based on the scores
1-15 – Slight Irritation
16-30 – Mild Irritation
31-75 – Moderate Irritation
76-110 – Severe Irritation


2.no data available
Irritation parameter:
other: 1.overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
other: 2.overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1.Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four.
2.the eyes show signs of reversible redness and swelling of the skin, which, according to Directive 83/467 / EEC, should not be considered as irritating
Interpretation of results:
other: not irritating
Conclusions:
The test material (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) was considered to be not irritating to the eyes of rabbits.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

An ocular irritation study was conducted by authoritative database for similar read across chemical on New Zealand rabbits. The purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits. The study was performed according to a modification of the method as described in the Code of Federal Regulations, section 1500.42 Guidelines. 6 New Zealand albino rabbits were used for the study. About 0.1ml undiluted test chemical was instilled in the left eye of the rabbits, while the right eye remained untreated and served as control. The treated eyes remained unwashed throughout the study. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material. Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four. The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits. Based on the scores and observations, the test substance was considered to be not irritating to rabbit eyes.

 

The above result was further supported by an eye irritation study reported by safety assessment report on rabbits for another read across chemical according to OECD 405 Guidelines. In this test, rabbits were exposed to the test chemical for 24 hours and observed for signs of irritation. The eyes showed signs of reversible redness and swelling of the conjunctiva, which, according to Directive 83/467 / EEC, should not be considered as irritating. Hence, the test material was considered to be not irritating to rabbit eyes.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

Skin irritation study of read across chemical was conducted by peer reviewed journal on human subjects to determine the degree of skin irritancy caused by the chemical. Each subject was treated with 4% of test chemical in petrolatum dermally for 48 hours under a closed path patch. Since no known signs of irritation were observed, the chemical was considered to be not irritating to the skin of human subjects.

 

The above result was supported by another skin study on female volunteers for another similar read across substance. During the test, approximately 4% of chemical was applied onto the forearm or back of each volunteer in petrolatum for 48 hours under occlusive condition. The chemical failed to cause skin irritation. Hence the chemical was considered as not irritating to the skin.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the ocular irritation potential of the test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0). The studies are as mentioned below:

 

An ocular irritation study was conducted by authoritative database for similar read across chemical on New Zealand rabbits. The purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits. The study was performed according to a modification of the method as described in the Code of Federal Regulations, section 1500.42 Guidelines. 6 New Zealand albino rabbits were used for the study. About 0.1ml undiluted test chemical was instilled in the left eye of the rabbits, while the right eye remained untreated and served as control. The treated eyes remained unwashed throughout the study. The treated eyes were observed and scored at 24, 48, and 72 hours as well as on days 4 and 7 after the instillation of the test material. Five animals showed slight irritation twenty-four hours after the instillation of the test material. Slight irritation was observed in four animals forty-eight hours after instillation. Seventy-two hours after the instillation of the test material slight irritation was observed in two animals. No irritation was observed in all the animals on day four. The overall scores for cornea, iris and conjunctivae after 7 days were 0 in all the rabbits. Based on the scores and observations, the test substance was considered to be not irritating to rabbit eyes.

 

The above result was further supported by an eye irritation study reported by safety assessment report on rabbits for another read across chemical according to OECD 405 Guidelines. In this test, rabbits were exposed to the test chemical for 24 hours and observed for signs of irritation. The eyes showed signs of reversible redness and swelling of the conjunctiva, which, according to Directive 83/467 / EEC, should not be considered as irritating. Hence, the test material was considered to be not irritating to rabbit eyes.

 

Based on the above summarized studies for target chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0) and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0)  and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical  is unlikely to cause skin and eye irritation. Hence (2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one (CAS No: 29461-13-0)  can be classified under the category “Not Classified” for skin and eye as per CLP