[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 15 to May 20, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 405 and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Adopted 09 October 2017

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

TBC_Inspected on / Signed on

Test material

Test material information

Constituent 1

Reference substance name:

(±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE

Cas Number:

1352216-65-9

Molecular formula:

C13H20O1

IUPAC Name:

(±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE

Constituent 2

Reference substance name:

(±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE

Cas Number:

1352216-63-7

Molecular formula:

C13H20O1

IUPAC Name:

(±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE

Test material form:

liquid

Details on test material:

Appearance: Colourless liquid

Specific details on test material used for the study:

Storage: Fridge, light protected, under nitrogen.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:
- Weight at study initiation: 2.52-2.73 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS - C15), ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: at least 10 cycles per hour.
- Photoperiod: 12 hours light/12 hours dark.

IN-LIFE DATES: From 15 April to 20 May 2019

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Test item was instilled, as supplied

Duration of treatment / exposure:

No washing was done

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h & Days 7, 14 and 21 following treatment, according to a numerical evaluation.

Number of animals or in vitro replicates:

3 males

Details on study design:

TREATMENT
- 0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to OECD guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 1 day

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 2 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 1 day

Irritant / corrosive response data:

The ocular reactions observed during the study have been moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 2 and 14, associated with a moderate chemosis noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 1 and 7;
- at the iris level: an injection was noted 1 hour after the test item instillation in one animal and was totally reversible on Day 3;
- at the corneal level: a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 14 and 21.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Individual and Mean Scores for Cornea, Iris and Conjunctivae

		Cornea	Iris	Conjunctivae
Rabbit Number	Time after Treatment	Corneal Opacity	Iris Lesion	Conjunctival Redness	Conjunctival Chemosis
Animal A7560	1h (D0)	0	1	1	0
	24h (D1)	2	1	2	2
	48h (D2)	2	1	2	2
	72h (D3)	1	0	2	2
	Day 7 (D7)	1	0	1	0
	Day 14 (D14)	1	0	0	0
	Day 21 (D21)	0	0	0	0
	Total (24, 48 and 72h)	5	2	6	6
	Mean (24, 48 and 72h)	1.7	0.7	2.0	2.0
Rabbit Number	Time after Treatment	Corneal Opacity	Iris Lesion	Conjunctival Redness	Conjunctival Chemosis
Animal A7584	1h (D0)	0	0	2	2
	24h (D1)	2	0	1	0
	48h (D2)	1	0	1	0
	72h (D3)	1	0	0	0
	Day 7 (D7)	1	0	0	0
	Day 14 (D14)	0	0	0	0
	Day 21 (D21)	-	-	-	-
	Total (24, 48 and 72h)	4	0	2	0
	Mean (24, 48 and 72h)	1.3	0.0	0.7	0.0
Rabbit Number	Time after Treatment	Corneal Opacity	Iris Lesion	Conjunctival Redness	Conjunctival Chemosis
Animal A7586	1h (D0)	0	0	2	2
	24h (D1)	0	0	1	0
	48h (D2)	0	0	0	0
	72h (D3)	0	0	0	0
	Day 7 (D7)	-	-	-	-
	Day 14 (D14)	-	-	-	-
	Day 21 (D21)	-	-	-	-
	Total (24, 48 and 72h)	0	0	1	0
	Mean (24, 48 and 72h)	0.0	0.0	0.3	0.0

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

Under the test conditions, the test material ST 03 C 18 is classified as irritating to eyes in Category 2 according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and in Category 2A according to the GHS.

Executive summary:

In an eye irritation study conducted according to OECD 405 guideline and in compliance with GLP, 3 New Zealand White male rabbits were exposed to 0.1 mL of test item in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 7, 14 and 21 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

 

The ocular reactions observed during the study have been moderate and totally reversible. At the conjunctivae level, a moderate redness noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 2 and 14, associated with a moderate chemosis noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 1 and 7. At the iris level, an injection was noted 1 hour after the test item instillation in one animal and was totally reversible on Day 3. At the corneal level, a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 14 and 21.

 

Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1.7, 1.0, 0.7 for cornea score; 0.3, 0.0, 0.0 for iris score; 1.7, 1.7, 1.0 for conjunctivae score and 1.3, 1.0, 1.3 for chemosis score.

 

Therefore, the test material, ST 03 C 18, is classified as irritanting to eyes in Category 2 according to the annex I of the Regulation EC No. 1272/2008 (CLP) and in Category 2A according to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.