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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To assess the eye irritation potential of the test chemical according OECD 405 Guidelines
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
EC Number:
266-100-3
EC Name:
4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol
Cas Number:
66068-84-6
Molecular formula:
C16-H28-O
IUPAC Name:
4-{5,5,6-trimethylbicyclo[2.2.1]heptan-2-yl}cyclohexan-1-ol
Test material form:
liquid
Details on test material:
Name of the test chemical: 3-(2,3,3-trimethyl-6-bicyclo[2.2.1]heptanyl)cyclohexan-1-ol
Common Name: Iso camphyl cyclohexanol
Molecular Formula: C16H28O
Molecular Weight: 236.396 g/mol
SMILES Notation: OC1CCC([C@@H]2[C@@H]3C[C@@H](C(C)(C)[C@@H]3C)C2)CC1
InChI: 1S/C16H28O/c1-10-14-8-12(16(10,2)3)9-15(14)11-4-6-13(17)7-5-11/h10-15,17H,4-9H2,1-3H3
Substance Type: Organic
Physical State: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Female
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2 kg+ 200g
- Housing:animals were housed individually in stainless steel cages provided with steel mesh bottom and facilities for food and water
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav Agro
- Water (e.g. ad libitum):Community tap water kept in glass bottles, ad libitum
- Acclimation period: The healthy rabbits selected for study were acclimatized to laboratory conditions one week prior to testing
- Identification: By cage tag and corresponding color body marking

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 degC
- Humidity (%): relative humidity - 40-60%
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 gm
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1,24,48 and 72 hours after test substance application
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3- [Initial test =1; and confirmatory tes = 2]
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: The eyes of the test animal were washed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: The examination of the reactions were facilatated by use of biomicroscope and hand slit lamp.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
0.1gm of the test chemical when applied to the eyes of New Zealand White rabbits did not produce any lesions such as pannus, staining through out the observation period of 72 hours.
Other effects:
There were no other signs observed through out the observation period of 21 days.

Any other information on results incl. tables

TABLE- 1     GRADING OF OCULAR LESIONS

 

S.NO/

SEX

 

OBSERVATION

Score

Total

Total Score

1/F

 

1 hr

24hrs

48 hrs

72 hrs

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

 

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0×5=0

Conjunctivae

A.       Redness

1

0

0

0

0

 

0+0 +0×5=0

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

2/F

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

 

0×0×5=0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0×5=0.0

Conjunctivae

A.       Redness

1

0

0

0

0

 

0+0 +0×5=0

B.       Chemosis

0

0

0

0

0

C.       Discharge 

0

0

0

0

0

3/F

Cornea

A.       Opacity-Degree of Density

0

0

0

0

0

 

0×0×5=0.0

B.       Area of Cornea Involved

0

0

0

0

0

Iris

A.       Values

0

0

0

0

0

0×5=0.0

Conjunctivae

A.       Redness

1

0

0

0

0

 

0+0 +0×5=0

B.       Chemosis

0

0

0

0

0

C.       Discharge 

1

1

0

0

2

Grand total

0

Mean

0

Eye Irritation Scoring Index

0

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
0.1gm of the test chemical when applied to the eyes of New Zealand White rabbits did not produce any lesions such as pannus, staining through out the observation period of 72 hours. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.
Executive summary:

Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405.

3 female New Zealand White Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment.

The test compound in the amount of 0.1 gm was applied as such and then placed in the conjunctival sac of one eye of each animal after gentle pulling the lower eye lid away from the eye ball. The eye lids were then gently held together for about one second to prevent the loss of the material. The other eyes which remains untreated, served as control. The eyes of the test animal were not washed for at least 24 hours following instillation of the test compound. After 24 hours, eyes were washed gently with the luke warm water. The eye was observed at 1, 24, 48 and 72 hours after test item instillation.

In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions till 24 hour observation hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. There were no other signs observed through out the observation period of 21 days.

 The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.

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