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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

15 - 18 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 spread on lint, which was applied and sealed onto the dorsal skin of one male rabbit under occlusive conditions for 4 h. Following application, the test substance was removed from the application site by wiping with an absorbent cotton soaked with acetone. The site was observed, in accordance with the Draize test, 1, 24, 48 and 72 h after removal of the test substance, the primary irritation index was calculated, and evaluation was performed.

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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, sterile cage.
- Diet: Solid rabbit feed (LRC4, Oriental Yeast) was available ad libitum 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

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL unchanged test substance

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

1 male

Details on study design:

TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: lint spread with test substance (2.5 × 2.5 cm^2), occlusive sealing

REMOVAL OF TEST SUBSTANCE
- Washing: The application site was wiped using absorbent cotton soaked with acetone to remove the test substance.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

OBSERVATION TIME POINTS
1, 24, 48, 72 h after removal of test substance

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema 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 observation after application, erythema (score: 2) and edema (score: 1) were observed at the site of application at observation point 1 h after application. These local reactions decreased at observation points 24 and 48 h (score 1 for erythema and edema, respectively) and completely disappeared 72 h after removal of the test substance. The primary irritation index (PDII) was 1.8, based on the sum of severities of local reactions (scores) for up to 72 h, divided by 4.

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 skin according to Draize criteria (PDII of 1.8). However, there is no need for classification according to Regulation (EC) No. 1272/2008.