Registration Dossier

Administrative data

Description of key information

Skin irritation:

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Eye Irritation:

By applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical 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:
for read across substance
Justification for type of information:
WoE report is based on two studies for the skin irritation potential for the test chemical
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two study of skin irritation for the test chemical :
1) To evaluate skin irritation potential of test material on 26 male volunteers.
2) To assess the dermal irritation potential of test material in humans
Species:
other: 1 and 2) Human volunteers
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: petrolatum
Amount / concentration applied:
1) 10% in petrolatum
2) 16% in petrolatum
Duration of treatment / exposure:
48 h
Observation period:
48 h
Number of animals:
1) 26 human male volunteers.
2) 25 human volunteers
Details on study design:
1) Test site: Back
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1)No irritation reaction were observed on 26 human male volunteers.
Interpretation of results:
other: Not irritating
Conclusions:
Test material was not irritating to human skin after 48 hours exposure.
Executive summary:

Data available for the test chemicals has been reviewed to determine the skin irritation potential of test substance .The studies are as mentioned below:

1)A pre-test for human maximization was performed to assess the dermal irritation potential of test chemical. The test chemical 10% in petrolatum was applied to the back of 26 male volunteers in a closed patch for 48 hours. The volunteers were observed for signs of irritation. No signs of irritation were noted in the volunteers after 48 hours. Hence, test material was considered to be not skin irritating in a pre test for human maximization assay.

2)A skin irritation study was performed on humans to assess the irritation potential of test material 16% in petrolatum was tested on human volunteers in a 48 hours closed patch test. The volunteers were observed for signs of irritation. Test material was not irritating to human skin after 48 hours exposure.

Based on the above experimental data it can be concluded that the test substance is not irritating to human skin.

 

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:
Weight of evidence approach based on various test chemicals
Justification for type of information:
Weight of evidence approach based on various test chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on various chemicals
Principles of method if other than guideline:
Weight of evidence approach based on various chemicals.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material: Isolongifolene
- IUPAC name: (2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene
- Molecular formula: C15H24
- Molecular weight: 204.3546 g/mole
- Smiles :CC1(C)CCC=C2C(C)(C)[C@H]3CC[C@@]12C3
- Inchl: 1S/C15H24/c1-13(2)8-5-6-12-14(3,4)11-7-9-15(12,13)10-11/h6,11H,5,7-10H2,1-4H3/t11-,15-/m0/s1
- Substance type: Organic
- Physical state: Liquid (colorless)
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. no data available
Vehicle:
other: 1. unchanged (no vehicle) 2. unchanged (no vehicle)
Controls:
other: 1. Yes, concurrent no treatment, Untreated right eye serving as a control. 2. not specified
Amount / concentration applied:
1. 0.1ml
2. no data available
Duration of treatment / exposure:
1. single exposure
2. 24 hours
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. no data available
Duration of post- treatment incubation (in vitro):
1. no data available
2. no data available
Number of animals or in vitro replicates:
1. 6
2. no data available
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
Other effects / acceptance of results:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
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
Other effects:
no data available
Interpretation of results:
other: not irritating
Conclusions:
By applying the weight of evidence approach, the test chemical can be considered to be not irritating to eyes. Comparing the annotations with criteria of CLP regulation, the test chemical 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 test chemicals has been reviewed to determine the skin irritation potential of test substance .The studies are as mentioned below:

1)A pre-test for human maximization was performed to assess the dermal irritation potential of test chemical. The test chemical 10% in petrolatum was applied to the back of 26 male volunteers in a closed patch for 48 hours. The volunteers were observed for signs of irritation. No signs of irritation were noted in the volunteers after 48 hours. Hence, test material was considered to be not skin irritating in a pre test for human maximization assay.

2)A skin irritation study was performed on humans to assess the irritation potential of test material 16% in petrolatum was tested on human volunteers in a 48 hours closed patch test. The volunteers were observed for signs of irritation. Test material was not irritating to human skin after 48 hours exposure.

Based on the above experimental data it can be concluded that the test substance is not irritating to human skin.

 

Eye Irritation:

The eye irritation potential of the test chemical was assessed based on the available results from the various test chemicals. The studies are summarized as below –

1. The purpose of the study was to assess the effects of the given 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. 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 given test chemical was considered to be not irritating to rabbit eyes.

2. An eye irritation study was performed on rabbits to assess the irritation potential of the given test chemical. The study was performed according to OECD 405 Guidelines. 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 skin, which, according to Directive 83/467 / EEC, should not be considered as irritating. Hence, the given test chemical was considered to be not irritating to rabbit eyes.

Justification for classification or non-classification

Available results for the test chemicals indicate a possibility that the test chemical can be considered to be not irritating to skin and eye. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".