2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 March to 26 March 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study undertaken to internationally accepted guidelines but before the implementation of GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41 Method of testing primary irritant substances

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

S-205

IUPAC Name:

S-205

Details on test material:

- Name of test material (as cited in study report): S-205
- Physical state: white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: reputable breeders
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.7 to 3.2 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to laboratory animal diet Grain Harvester 474 Special Rabbit Pellets
- Water (e.g. ad libitum): free access to tap water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12hrs light

IN-LIFE DATES: From: 23 March 1982 To: 26 March 1982

Test system

Type of coverage:

occlusive

Preparation of test site:

other: 10 cm square shaved then 2.5 cm square on the right side of the spine was abraded

Vehicle:

water

Remarks:

to moisten the substance

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): 1g/mL

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5mL of water

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm square of abraded skin and 2.5 cm square of intact skin
- Type of wrap if used: gauze pads covered by "Elastoplast" elastic adhesive dressing backed with "Sleek" plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment sites were wiped to remove any residual test substance
- Time after start of exposure: 24 h

SCORING SYSTEM: Scoring was performed at 24 h and 72 h

Erythema and eschar formation:
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erytryema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 No oedema
1 Very slight oedema (barely perceptible) 1
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No dermal reactions were seen in any of the rabbits after 24 h exposure to S-205 during the 72 h observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

S-205 is not considered to be an irritant to rabbit skin