(2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from NTRL report.

Data source

Reference

Reference Type:

other: secondary source

Title:

The effects of test chemical on the eye mucosa of New Zealand Albino Rabbits

Author:

NTRL

Year:

1974

Bibliographic source:

NTRL report, last updated 1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: A modification of the method as described in the Code of Federal Regulations, section 1500.42 was used in this experiment

Principles of method if other than guideline:

The purpose of the study was to assess the effects of test chemical on the eye mucosa of rabbits.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate

EC Number:

227-561-6

EC Name:

Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate

Cas Number:

5888-33-5

Molecular formula:

C13H20O2

IUPAC Name:

(1S,2S,4S)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl prop-2-enoate

Details on test material:

- IUPAC Name: Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate
- Mol. formula: C13H20O2
- Molecular Weight: 208.299 g/mole
- InChI: 1S/C13H20O2/c1-5-11(14)15-10-8-9-6-7-13(10,4)12(9,2)3/h5,9-10H,1,6-8H2,2-4H3/t9-,10-,13+/m1/s1
- Smiles: CC1(C)[C@@H]2CC[C@@]1(C)[C@@H](C2)OC(=O)C=C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1ml

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

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

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

Total = 6

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

Results and discussion

In vivo

Results

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

Irritant / corrosive response data:

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.

Other effects:

No data

Any other information on results incl. tables

 Table Eye Irritation in rabbits

Animal number	Cornea A*B*6		Iris A*5	Conjunctivae (A+B+C)*2			Total score per animal
	A	B	A	A	B	C
24 hours – No wash
1	1	1	0	1	0	0	7
2	1	1	0	1	1	0	9
3	0	0	0	0	0	0	0
4	1	1	0	1	1	1	11
5	1	1	0	1	1	0	9
6	1	1	0	1	0	0	7
48 hours – No wash
1	1	1	0	1	0	0	7
2	1	1	0	1	0	0	7
3	0	0	0	0	0	0	0
4	1	1	0	1	1	0	9
5	1	1	0	1	0	0	7
6	0	0	0	0	0	0	0
72 hours – No wash
1	1	1	0	1	0	0	7
2	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0
4	1	1	0	1	0	0	7
5	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0
4 days – No wash
1	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0
5	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0
7 days – No wash
1	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0
5	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

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.

Executive summary:

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.0.1 ml 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.