N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

The in vivo eye irritation study was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 February 2014 to 06 March 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine

EC Number:

941-634-6

Cas Number:

1228284-78-3

Molecular formula:

C10H12Cl3NO

IUPAC Name:

methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine

Test material form:

other: liquid

Details on test material:

- Physical state: Brown liquid
- Expiration date of the lot/batch: Recertification date end September 2015
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 3378-3688 g
- Housing: Individually housed in AAALAC approved open-wire metal cages.
- Diet: UNI diet for rabbits ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1-20.4
- Humidity (%): 28-68
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 25 February 2014 To: 06 March 2014

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

Single application (treated eye rinsed with physiological saline solution 1 hour after application).

Observation period (in vivo):

72 hours.

Number of animals or in vitro replicates:

3 males.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 1 hour.

SCORING SYSTEM: Draize (1977) and OECD 405 (02 October 2012)

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

mean

Time point:

other: 24-72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were seen in all rabbits 1 hour after treatment. Conjunctival redness (score 1 or 2), chemosis (score 1) and discharge (score 1 or 2 or 3) were seen in all rabbits and corneal opacity (score 1, area 3) was noted in one rabbit 24 hours after treatment. Conjunctival redness (score 1 or 2) and discharge (score 1) were seen in all rabbits 48 hours after treatment. All symptoms had fully reversed in all animals by the 72 hours observations. Fluorescein staining was positive in one rabbit at 24 hours after instillation. Fluorescein staining was negative in two animals at 24 and in all animals at 48 and 72 hours after instillation. Control eyes were symptom-free during the study.

Other effects:

None.

Any other information on results incl. tables

Table 1: Eye irritation scores according to the Draize scheme

Time		Cornea			Iris			Conjunctiva
								Redness			Chemosis
	Animal number	719	718	889	719	718	889	719	718	889	719	718	889
after 1 hour		0	0	0	0	0	0	2	2	2	1	1	1
after 24 hours		1	0	0	0	0	0	2	2	1	1	1	1
after 48 hours		0	0	0	0	0	0	2	1	1	0	0	0
after 72 hours		0	0	0	0	0	0	0	0	0	0	0	0
mean scores 24-72 hours		0.3	0	0	0	0	0	1.3	1.0	0.7	0.3	0.3	0.3

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was graded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.

Executive summary:

The test item was administered as a single dose of 0.1 mL into the conjunctival sac of the left eye of each of 3 young adult male New Zealand White rabbits, the untreated right eye served as a control. Irritation was scored approximately 1, 24, 48 and 72 hours after administration. Observations with fluorescein staining were made approximately 24 hours before and 24, 48 and 72 hours after treatment. Rabbits were treated with analgesic and anaesthetic as per the regulatory guideline.

Conjunctival redness (score 2), chemosis (score 1) and discharge (score 3) were seen in all rabbits at 1 hour after treatment. Conjunctival redness (score 1 or 2), chemosis (score 1) and discharge (score 1 or 2 or 3) were seen in all rabbits and corneal opacity (score 1, area 3) was noted in one rabbit at 24 hours after treatment. Conjunctival redness (score 1 or 2) and discharge (score 1) were seen in all rabbits at 48 hours after treatment. All symptoms had fully reversed in all animals by the 72 hours observations. Fluorescein staining was positive in one rabbit at 24 hours after instillation. Fluorescein staining was negative in two animals at 24 and in all animals at 48 and 72 hours after instillation. The control eye of animals was symptom-free during the study. No mortality occurred during the study. The bodyweights of all rabbits were considered to be within the normal range of variability.

The test item was graded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.