Distillate of avocado oil, Persea gratissima, Lauraceae

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

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

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: glittery semi-liquid

Details on test material:

Colour: orange

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

During the test, the animals (females) weighed between 1.93 kg and 2.56 kg. At the beginning of the test, the animals were 10-12 weeks old.

Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17 to 23 °C and 30 to 70 %, respectively.
The rate of air exchange was approximately thirteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Drinking water and foodstuff were supplied freely.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye remained untreated serving as control.

Amount / concentration applied:

0.1 mL of the test item was instilled as supplied.

Duration of treatment / exposure:

24 hours of exposure.

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D21 in order to determine the reversible character of the lesions observed.

Number of animals or in vitro replicates:

Three female albino New Zealand rabbits were treated sequentially.
After consideration of the responses produced on day 3 in the first animal, two additional animals were treated, in the same experimental conditions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.7

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.7

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.3

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.7

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.7

Irritant / corrosive response data:

The ocular reactions observed during the study have been slight to important and totally reversible:
- at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between days 3 and 14, associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 7;
- at the iris level : a congestion, noted 1 hour after the test item instillation in two animals and totally reversible between days 1 and 2.
- at the corneal level : a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 2 and 3.

Other effects:

None.

Any other information on results incl. tables

Animal No.	Time after treatment	CONJUNCTIVAE		IRIS	CORNEA
		Chemosis (A)	Redness (C)	Lesion (D)	Opacity (E)
1	24 hours	0	2	0	0
	48 hours	0	1	0	0
	72 hours	0	0	0	0
	Mean	0.0	1.0	0.0	0.0
2	24 hours	1	2	1	2
	48 hours	1	2	0	2
	72 hours	1	1	0	0
	Mean	1.0	1.7	0.3	1.3
3	24 hours	2	2	0	2
	48 hours	1	2	0	0
	72 hours	1	1	0	0
	Mean	1.3	1.7	0.0	0.7

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.

In accordance with the Regulation (EC) No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.

Executive summary:

The test item C.A.E. Code: 8500010 was instilled as supplied into the eye of three New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established according to the OECD guideline No.405 dated April 24^th, 2002 and the test method B.5 ohe council regulation No.440/2008.

 

The ocular reactions observed during the study have been slight to important and totally reversible:

-  at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible between days 3 and 14, associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 7;

-  at the iris level : a congestion, noted 1 hour after the test item instillation in two animals and totally reversible between days 1 and 2.

-  at the corneal level : a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 2 and 3.

 

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item C.A.E. Code: 8500010 must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 1999/45. No symbol or risk phrase is required.

 

In accordance with the Regulation (EC) No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified.No signal word or hazard statement is required.