4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 19 Jan 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Each animal is additionally treated with 3 different dilutions of test substance. No analytical purity of test substance given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

each animal is additionally treated with 3 different dilutions of test substance

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(Commission Directive 84/449/EEC)

Deviations:

yes

Remarks:

each animal is additionally treated with 3 different dilutions of test substance

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

EC Number:

241-997-4

EC Name:

4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin

Cas Number:

18096-62-3

Molecular formula:

C11H12O2

IUPAC Name:

2H,4H,4aH,5H,9bH-indeno[1,2-d][1,3]dioxine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.15 - 2.17 kg
- Housing: individually in metal cages
- Diet: Rabbit Diet (Preston Farmers Limited, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 59 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: diethyl phthalate/ethanol (1:1)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentrations: 2, 10, 50% (w/w) and 100%

Duration of treatment / exposure:

4 hours

Observation period:

7 days
Reading time point: 1, 24, 48, 72 hours and 7 days

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The treated skin was covered with a gauze patch and held in place with surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Skin sites were gently swabbed with cotton wool soaked in ethanol.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: undiluted test substance

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: undiluted test substance

Results 3

Irritation parameter:

edema score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversiblitiy: not applicable

Remarks on result:

other: undiluted test substance

Irritant / corrosive response data:

Undiluted test substance: No adverse skin reactions were noted at any treated skin site 1 hour after patch removal. Very slight erythema was noted at the time points 24 and 48 hours. Desquamation was noted at two treatment sites at the 72-hour observation and at one treatment site at the 7-day observation. Very slight oedema was noted at one treatment site at the 24-hour observation.
50% dilution: Very slight erythema was noted at the reading time points 24 and 48 hours and at two treatment sites at the 72-hours observation. Desquamation was noted at two treatment sites at the 7-day observation. Very slight oedema was noted at all treatment sites at the 24-hour observation and at one treatment site at the 48-hour observation.
10% dilution: Very slight erythema was noted at one treatment site one hour after patch removal and at all treatment sites at the 24-and 48-hour observations. Very slight erythema or desquamation was noted at two treatment sites at the 72-hour observation. Desquamation only was noted at these sites at the 7-day observation. Slight oedema was noted at one treatment site at the 24-hour observation with very slight oedema at the 48-hour observation.
2% dilution: Very slight erythema was noted at one treatment site one hour after patch removal. Very slight or well-defined erythema was noted at all treatment sites at the 24-hour observation. Very slight erythema was noted at two treatment sites at the 48 and 72-hour observations with desquamation only at these sites at the 7-day observation. Slight oedema was noted at one treatment site at the 24-hour observation with very slight oedema at the 48-hour observation.

Any other information on results incl. tables

Table 1: Individual skin examination scores with 100, 50, 10 and 2% test substance

Animal	Concentration %	Erythema/Eschar formation						Oedema formation
		1 h	24 h	48 h	72 h	7 d	Mean 24/48/72 h	1 h	24 h	48 h	72 h	7 d	Mean 24/48/72 h
1 (male)	100% (undiluted)	0	1	1	0D	0D	0.67	0	1	0	0	0	0.33
	50%	0	1	1	0	0	0.67	0	1	0	0	0	0.33
	10%	0	1	1	0D	0D	0.67	0	0	0	0	0	0
	2%	0	1	0	0	0	0.33	0	0	0	0	0	0
2 (male)	100% (undiluted)	0	1	1	0	0	0.67	0	0	0	0	0	0
	50%	1	1	1	1	0D	1	0	1	1	0	0	0.67
	10%	0	1	1	0	0	0.67	0	0	0	0	0	0
	2%	1	1	1	1	0D	1	0	0	0	0	0	0
3 (female)	100% (undiluted)	0	1	1	0D	0	0.67	0	0	0	0	0	0
	50%	0	1	1	1	0D	1	0	1	0	0	0	0.33
	10%	1	1	1	1	0D	1	0	2	1	0	0	1
	2%	0	2	1	1	0D	1.33	0	2	1	0	0	1

D: desquamation

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this skin irritation study in rabbits the undiluted test substance (100%) was not irritating to the skin. Also the test substance concentrations of 2, 10 and 50% in ethanol/diethylphthalat (1:1) did not show an irritation potential.