Phthalide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1977

Materials and methods

Principles of method if other than guideline:

Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test).
 
White Vienna rabbits were used. 2 animals were treated for 1, 5, 15 minutes and 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal / lateral flank of the back.
 
After the application time, the skin was washed with water which contained a mild detergent. The animals were observed 8 days and skin changes were recorded on working days. The report usually describes findings after 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phthalide

EC Number:

201-744-0

EC Name:

Phthalide

Cas Number:

87-41-2

Molecular formula:

C8H6O2

IUPAC Name:

1,3-dihydro-2-benzofuran-1-one

Details on test material:

- Name of test material (as cited in study report): Phthalid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.9 - 3.2 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

80% in water

Duration of treatment / exposure:

1, 5 and 15 min and 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol diluted to 50 % with warm water
- Time after start of exposure: 1, 5 and 15 min and 20 h, respectively

SCORING SYSTEM:
The original scoring system was converted into Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Readings	Animal	Exposure period: 20 h
		Erythema	Edema	Additional findings
1 h	1	0	0	-
	2	0	0	-
24 h	1	0	0	-
	2	0	0	-
48 h	1	0	0	-
	2	0	0	-
72 h	1	0	0	-
	2	0	0	-
Mean 24, 48, 72 h	1	0	0	-
	2	0	0	-
Mean 24, 48, 72 h	1-2	0	0	-

No erythema and no edema were observed (score 0 according to the OECD/Draize scheme).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met