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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 June 2003 to 17 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 housed 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE:
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cotton gauze patch secured with a strip of surgical adhesive tape. Animal was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE:
- Washing: yes
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 Dyas

Remarks on result:

other: Reaction extends 3 cm beyond treatment site, light brown discolouration of the epidermis, loss of skin elasticity, and slight desquamation noted

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 Days

Irritant / corrosive response data:

The individual scores for erythemaleschar and oedema, are given in the table 1 at any other information on results.
Well-defined erythema was noted at all treated skin sites 1 hour after patch removal and at the 24, 48 and 72-hour observations. The reaction extended 3 cm beyond the treatment sites at the 24, 48 and 72-hour observations.
Slight oedema was noted at all treated skin sites one hour after patch removal and at the 24, 48 and 72-hour observations.
Light brown discolouration of the epidermis was noted at all treated skin sites at the 48 and 72-hour observations with an isolated incident of loss of skin elasticity at the 72-hour observation.
Severe desquamation was noted at all treated skin sites at the 7 -day observation.
All treated skin sites appeared normal at the 14-day observation.

Any other information on results incl. tables

Table 1. Individual Skin Reactions.

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		#1 Male	#2 Male	#3 Female
Erythema Formation	1 hour	2	2	2	(6)
	24 hours	2R	2R	2R	6
	48 hours	2RBr	2RBr	2RBr	(6)
	72 hours	2RBrLe	2RBr	2RBr	6
	7 days	0D	0D	0D	(0)
	14 days	0	0	0	(0)
Oedema Formation	1 hour	2	2	2	(6)
	24 hours	2	2	2	6
	48 hours	2	2	2	(6)
	72 hours	2	2	2	6
	7 days	0	0	0	0
	14 days	0	0	0	(0)
Sum of 24 and 72-hour Readings (S): 24
Primary Irritation Index (S/6): 24/6 = 4.0

( ) = Total values not used for calculation of primary irritation index

R = Reaction extends 3 cm beyond treatment site

Br = Light brown discolouration of the epidermis

Le = Loss of skin elasticity

D = Slight desquamation

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 404.

Executive summary:

An in vivo skin irritation test was performed in accordance with OECD TG 404 and under GLP-conditions, to assess the irritancy potential of the test substance to the skin of the New Zealand White rabbit. A single 4-hour, semi-occluded application of the test substance to the intact skin of 3 rabbits produced well-defined erythema and slight oedema. These reactions scored maximally score 2 (Draize) and extended beyond all treated skin sites at the 24, 48 and 72-hour observations but was reversible within 14 days. Light brown discolouration, loss of skin elasticity and severe desquamation were also noted. No corrosive effects were observed. The test substance is considered not a skin irritant.