[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one

Eye irritation

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:

other: Equivalent or similar to OECD 405. There is no GLP compliance statement in the report but it is indicated that the study was designed to ensure compliance with the Code of GLP published in the Federal Register, December 1978.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one

EC Number:

251-020-3

EC Name:

[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one

Cas Number:

32388-55-9

Molecular formula:

C17H26O

IUPAC Name:

1-((3R,3aR,7R,8aS)-3,6,8,8-tetramethyl-2,3,4,7,8,8a-hexahydro-1H-3a,7-methanoazulen-5-yl)ethanone

Test material form:

other: clear yellow pale liquid

Details on test material:

- Name of test material (as cited in study report): IFF #80-004-06 , which is confirmed as Methyl Cedryl Ketone by data holder IFF
- Physical state: clear yellow pale liquid
- Storage condition of test material:Supplied in an amber bottle

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: between 2.0 and 3.5 kg
- Housing: Housed individually under standard lab conditions
- Diet (e.g. ad libitum): 100g purina rabbit chow supplemented with whole oats
- Water (e.g. ad libitum): ad libitum
The criteria for housing and maintenance were those specified in the 'Guide for the Care and Use of Laboratory Animals' (DHEW Publication No. (NIH) 78-23, Revised 1978).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

24, 48 and 72 hrs and at 4 and 7 days after dosing.

Number of animals or in vitro replicates:

6 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was not washed after instillation of the test article.

SCORING SYSTEM: Method of Draize/Table: Grading of Ocular Lesions in OECD 405 with additions noted below in Tables 1 and 2.

TOOL USED TO ASSESS SCORE: Both eyes examined with fluorescein under UV light (24 hrs and 7 days)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Opacity

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

None of the dosed eyes had any reaction during the 7 day observation period (Table 3) so no animal was retained for examination on day 10. All eyes were negative for fluorescein retention. Individual animal data is presented below.

The mean ocular irritation scores were:

0 at 24 hours
0 at 48 hours
0 at 72 hours
0 at 4 days
0 at 7 days

Any other information on results incl. tables

Table 3: Score chart for primary eye irritation (all timepoints)

	Cornea (Max. 4)					Iris (Max. 2)					Conjunctivae (Max. 3/3 and 4)
	Opacity and Area										Redness/Discharge and Chemosis
Animal	24h	48h	72h	Day 4	Day 7	24h	48h	72h	Day 4	Day 7	24h	48h	72h	Day 4	Day 7
A-1132	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
A-1131	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
A-1130	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
A-1134	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
A-1133	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
A-1135	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Weighted score	0					0					0
Total	0					0					0
Primary Occular Irritation Score	0					0					0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance methyl cedryl ketone was not irritating in the eyes of New Zealand White rabbits in this study.

Executive summary:

In a primary eye irritation study (0267), 0.1 mL of  Methyl Cedryl Ketone was instilled into the conjunctival sac of the right eye of 6 young female rabbits (New Zealand white) for 24 hours.  The eye was not washed after instillation of the test article.  Animals were then observed for 24, 48 and 72 hour and at 4 and 7 days after dosing.  Irritation was scored by the method of Draize/Table: Grading of Ocular lesions (OECD 405) with additions noted in Tables 1 and 2.

 

None of the dosed eyes had any reaction during the 7 day observation period.

In this study, Methyl Cedryl Ketone is not an eye irritant.