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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41 Method of testing primary irritant substances

Deviations:

not specified

GLP compliance:

not specified

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

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)

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.

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 to 29 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.

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42: Test for eye irritants

Deviations:

not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: reputable
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.3 to 3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): laboratory animal diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: yes but no details

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

IN-LIFE DATES: From: 22 March 1982 To: 29 March 1982

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

50mg of S-205 (corresponding to a volume of 0.1mL)

Duration of treatment / exposure:

S-205 was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The eyes were not washed out.The contralateral eye remained untreated and served as a control.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable

SCORING SYSTEM: "Illustrated Guide for Grading Eye Irritation Caused by Hazardous Substances", Directorate for Engineering and Science.
u.S. Consumer Product Safety Commission, Washington D.C. 20207.

TOOL USED TO ASSESS SCORE: a handheld torch

Irritant / corrosive response data:

Mild inflammation or a diffuse crimson-red colouration of the conjunctivae was seen in three rabbits. The eyes of two of these rabbits were normal by Day 2 and that of the third by Day 4. No ocular reactions were recorded in the remaining three rabbits.

Rabbit Number and sex	Region of the eye		Day after instillation
			1	2	3	4	7
2744 F	Cornea		0	0	0	0	0
	Iris		0	0	0	0	0
	Conjunctivae	Redness	2	1	1	0	0
		Chemosis	0	0	0	0	0
2763M	Cornea		0	0	0	0	0
	Iris		0	0	0	0	0
	Conjunctivae	Redness	0	0	0	0	0
		Chemosis	0	0	0	0	0
2765F	Cornea		0	0	0	0	0
	Iris		0	0	0	0	0
	Conjunctivae	Redness	1	0	0	0	0
		Chemosis	0	0	0	0	0
2766F	Cornea		0	0	0	0	0
	Iris		0	0	0	0	0
	Contjunctivae	Redness	0	0	0	0	0
		Chemosis	0	0	0	0	0
2767M	Cornea		0	0	0	0	0
	Iris		0	0	0	0	0
	Conjunctivae	Redness	0	0	0	0	0
		Chemosis	0	0	0	0	0
2768F	Cornea		0	0	0	0	0
	Iris		0	0	0	0	0
	Conjunctivae	Redness	1	0	0	0	0
		Chemosis	0	0	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The eye irritation test for S-205 was negative

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
No other study available.

Justification for selection of eye irritation endpoint:
No other study available.

Justification for classification or non-classification

Study results show that S-205 is not an irritant to skin or eye. Therefore it will not be classified as an irritant.