(1'R,2R)-2-Methyl-4-(2',2',3'-tri-nal and methylcyclopent-3'-en-1'-yl)-4-pent-enal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-01-1995 to 27-01-1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

422-120-6

EC Name:

-

Cas Number:

166432-53-7

Molecular formula:

C14H22O

IUPAC Name:

2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-enal

Test material form:

liquid

Details on test material:

- Physical state: Liquid
- Storage condition of test material: in the refrigerator in the dark
- Other: clear colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Young adult
- Weight at study initiation: 2.6 – 2.9 kg
- Housing: Individually housed in grid bottomed metal cages
- Diet: certified rabbit diet ad libitum (details in the full study report)
- Water: filtered certified water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -21
- Humidity (%): 35 - 60
- Air changes (per hr): Not reported, however reported as air conditioned
- Photoperiod: 12 hours light / 12 hours dark

IN-LIFE DATES: From: 10-01-1995 To: 14-01-1995

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

A volume of 0.1 mL of the test item, was placed into the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few seconds immediately and then moved gently to distribute the test item around the surface of the eye. The left eye remained untreated (and was used for control purposes).

Observation period (in vivo):

Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test item, according to numerical evaluation.

Number of animals or in vitro replicates:

3 (sex not specified).

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Not applicable.

SCORING SYSTEM:
The irritation was assessed using criteria consistent with Draize (1977) numerical scoring system. At each observation period, each eye was assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light from a standard light source according to BS 950 (artifical daylight for the assessment of colour).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: mean; n=3

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: mean; n=3

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: mean; n=3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: mean; n=3

Irritant / corrosive response data:

No corneal or Iridial inflammation effects were noted. Very slight conjunctival reactions (redness, score = 1) was noted in treated eyes 1 hour after treatment. No chemosis effects were noted. All effects resolved within 24 hours observation.

Other effects:

- Lesions and clinical observations: None reported.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: None reported.
- Effects of rinsing or washing: Not applicable.
- Other observations: None reported.

Any other information on results incl. tables

Table 1. Individual scores and mean scores for 24, 48 and 72 hours

Organism number and sex	Time after treatment	Corneal Opacity	Iridial Inflammation	Conjunctival Redness	Conjunctival Chemosis
1 (sex not specified)	1h	0	0	1	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Day 4	-	-	-	-
Mean (24 – 72 h)		0.00	0.00	0.00	0.00
2 (sex not specified)	1h	0	0	1	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Day 4	-	-	-	-
Mean (24 – 72 h)		0.00	0.00	0.00	0.00
3 (sex not specified)	1h	0	0	1	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Day 4	0	0	0	0
Mean (24 – 72 h)		0.00	0.00	0.00	0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test item is not irritating to the eye.

Executive summary:

The study was performed to EU Method B.5 and/or a method equivalent or similar to OECD TG 405 under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test item was placed into the left eye of three animals sequentially using the first as a sentinel. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of three rabbits produced no corneal or Iridial inflammation effects. Slight conjunctival reaction (hyperaemia or redness, score = 1 and/or discharge, score = 1) was noted in treated eyes at 1 hour after treatment. No chemosis effects were noted. All treated eyes appeared normal at the 24 hours observation point. Under the conditions of this study, the test item is not considered to be irritating to the eye.