(3R)-1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

21 - 24 Oct 2013

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was applied to the right eye of one male rabbit; the left eye was untreated and served as a control. The eyes were observed, in accordance with the Draize test (1944), 1, 24, 48 and 72 h after application, and evaluation was performed in accordance with the Kay and Calandra method (1962).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(3R-)1,1,3-trimethylindan-4-amine

EC Number:

836-285-0

Cas Number:

125349-37-3

Molecular formula:

C12H17N

IUPAC Name:

(3R-)1,1,3-trimethylindan-4-amine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Sex: male
- Age at study initiation: 16 weeks
- Weight at study initiation: 2975 g
- Housing: The animal was housed individually in a suspended stainless-steel cage comprising stainless steel wire mesh front and floor, and aluminium walls (W590 × D636 × H430 mm, Clea Japan, Inc.). Once every 2 weeks, the cage was changed for a washed, sterilised cage.
- Diet: Solid rabbit feed (LRC4, Oriental Yeast) was freely available at ca. 120 g/day.
- Water: Tap water was provided freely available via an automatic water dispensing device (Lab Engineering Co., Ltd).
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): ≥ 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL unchanged test substance

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
(Reading points: 1, 24, 48, 72 h after application)

Duration of post- treatment incubation (in vitro):

not applicable

Number of animals or in vitro replicates:

1 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM:
The eyes were monitored in accordance with the criteria of Draize (1944), and evaluated in accordance with the method of Kay and Calandra (1962).

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

In observations 24 h after application, corneal clouding (evaluations: severity 1, size 1), iris hyperaemia (evaluation: 1), flushing of the conjunctiva (evaluation: 1), oedema (evaluation: 1) and rheumy discharge (evaluation: 1) were observed. These local reactions had completely disappeared 72 h after application. The maximum value (MMTS) up to 72 h after application was 16 (reached after 24 h application).

Any other information on results incl. tables

Table 1: Results of the eye irritation study

Rabbit #	Time		Conjunctivae			Iris	Cornea		Total Score (MTS)
			Flushing	Oedema	Rheumy discharge
						Hyperaemia	Clouding severity	Clouding size
1	1 h	P	1	1	1	1	0	0
		S			6	5		0	11
	24 h	P	1	1	1	1	1	1
		S			6	5		5	16
	48 h	P	1	1	0	0	0	0
		S			4	0		0	4
	72 h	P	0	0	0	0	0	0
		S			0	0		0	0
	average (P 24 / 48 / 72 h)		0.7	0.7		0.3	0.3

P= Intensity (score); S = Score

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Under the present test conditions, the test substance (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine was assessed to be mildly irritant to the eye according to Kay and Calandra criteria, and to fall under the category of "no classification" according to Regulation (EC) No. 1272/2008.