Indeno[4,3a-b]furan, decahydro-2,2,7,7,8,9,9-heptamethyl-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 June 2003 to 27 June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

449-360-4

EC Name:

-

Cas Number:

647828-16-8

Molecular formula:

C18H32O

IUPAC Name:

decahydro-2,2,6,6,7,8,8-heptamethyl-2H-Indeno[4,5-b] furan

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS:
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Individually in suspended metal cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control purposes.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49.

TOOL USED TO ASSESS SCORE:
Light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects observed

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: No effects observed

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Effects noted at one hour, fully reversible within 24 hours

Irritant / corrosive response data:

Individual and group mean scores for ocular irritation are given in Table 1 and 2.
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes 1-hour after treatment with minimal conjunctival irritation in all treated eyes at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.

Other effects:

None

Any other information on results incl. tables

Table1. Individual Scores and Individual Total Scoresfor Ocular Irritation.

Rabbit Number and Sex	#1 Male				#2 Male				#3 Male
	IPR=3				IPR=0+				IPR=0+
Time After Treatment	1 hr	24 hr	48 hr	72 hr	1 hr	24 hr	48 hr	72 hr	1 hr	24 hr	48 hr	72 hr
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = Redness	2	1	0	0	1	1	0	0	1	1	0	0
B = Chemosis	1	0	0	0	1	0	0	0	1	0	0	0
C = Discharge	2	1	0	0	2	1	0	0	2	1	0	0
Score (A + B + C) x 2	10	4	0	0	8	4	0	0	8	4	0	0
Total Score	10	4	0	0	8	4	0	0	8	4	0	0

IPR= Initial pain reaction

+= One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment.

Table 2. Individual Total Scores and Group Mean Scores for Ocular Irritation.

Rabbit Number and Sex	Individual Total Scores At:
	1 hour	24 hour	48 hours	72 hours
#1 Male	10	4	0	0
#2 Male	8	4	0	0
#3 Female	8	4	0	0
Group Total	26	12	0	0
Group Mean Scores	8.7	4.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

other: Not a skin irritant according to EU CLP (EC 1272/2008 and its amendments).

Conclusions:

The test substance was considered to be non-irritanting to skin based on OECD TG 405.

Executive summary:

An in vivo eye irritation study in accordance with OECD TG 405 and under GLP conditions was performed to assess the irritant potential of the test substance to the eye of the New Zealand White rabbit. A single application of the test substance to the non-irrigated eye of 3 rabbits produced slight conjunctival irritation with maximum average score of 0.33. All treated eyes appeared normal at the 48-hour observation. The substance is not considered an eye irritant.