Distillate of avocado oil, Persea gratissima, Lauraceae

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

During the test, the animals (males) weighed 1.92 kg and 2.47 kg. At the beginning of the test, the animals were 10-11 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: On the opposite flank an untreated area was served as the control.

Amount / concentration applied:

The test item C.A.E. Code: 8500010 was applied, as supplied, at the dose of 0.5 mL.

Duration of treatment / exposure:

The undamaged skin area of one flank of each animal was exposed during 4 hours.

Observation period:

The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after treatment the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D14 in order to determine the reversible character of the lesions observed.

Number of animals:

3 animals were treated sequentially.
Initially, a single animal was treated. After considerations of the cutaneous responses produced in the first animal on day 14, two additional animals were treated during 4 hours in the same experimental conditions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

see conclusions

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

see conclusions

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

see conclusions

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

see conclusions

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

see conclusions

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other:

Remarks:

see conclusions

Irritant / corrosive response data:

A well defined erythema was noted on the treated area, 1 hour after the patch removal, and was totally reversible on day 7. A slight oedema was noted on the treated area, 1 hour after the patch removal, and was totally reversible between days 3 and 7.
On the cutaneous structure, dryness of the skin was noted from day 3 in one animal and from day 7 in two animals. The skin recovered a normal aspect on day 14 in two animals but the dryness of the skin was still noted on day 14 in one rabbit (end of the observations).

Other effects:

None.

Any other information on results incl. tables

OBSERVATIONS	INDIVIDUAL DATA
Skin reactions	Observation time	Animal 1	Animal 2	Animal 3
Erythema and eschar	24 hours	2	1	1
	48 hours	2	1	1
	72 hours	1	1	1
MEAN		1.7	1.0	1.0
Oedema	24 hours	2	0	0
	48 hours	1	1	1
	72 hours	1	0	0
MEAN		1.3	0.3	0.3

 

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The results obtained, in 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, 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 applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of three New Zealand rabbits. The experimental protocol was established according to the OECD guideline No.404 dated April 24^th, 2002 and the test method B.4 of the Council regulation No.440/2008 of 30 May 2008.

 

A well defined erythema was noted on the treated area, 1 hour after the patch removal, and was totally reversible on day 7. A slight oedema was noted on the treated area, 1 hour after the patch removal, and was totally reversible between days 3 and 7.

On the cutaneous structure, dryness of the skin was noted from day 3 in one animal and from day 7 in two animals. The skin recovered a normal aspect on day 14 in two animals but the dryness of the skin was still noted on day 14 in one rabbit (end of the observations).

 

The results obtained, in 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, the test item must not be classified. No signal word or hazard statement is required.