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

Eye irritation

Administrative data

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.

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 1500.42: Test for eye irritants

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 / tissue source

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

Test system

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

Results and discussion

In vivo

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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