Fast Pyrolysis Bio-oil

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 March 2005 - 11 March 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (final report not dated nor signed by the study director)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the study plan

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 2004/73/EC B.4, 29th April 2004

GLP compliance:

yes (incl. QA statement)

Remarks:

Agence Francaise de Securite Sanitaire des Produits de Sante

Test material

Test material information

Constituent 1

Reference substance name:

Fast Pyrolysis Bio-oil (BIOTOX-21)

IUPAC Name:

Fast Pyrolysis Bio-oil (BIOTOX-21)

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Supplier: ASTON
name: BIOTOX-21
batch number: on the analytical certificate: 110205
description: brown liquid
storage conditions: at + 4 °C and protected from light
purity: 100 %
stability: February 2006.

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Controls:

no

Duration of treatment / exposure:

The durations of exposure were 3 minutes, 1 hour and 4 hours.

Observation period:

The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.

Number of animals:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Remarks:

4-hour exposure, mean of scores

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Results 2

Irritation parameter:

edema score

Remarks:

4-hour exposure

Basis:

animal #1

Time point:

other: 48/72 h

Score:

1

Remarks on result:

other: a very slight edema

Results 3

Irritation parameter:

edema score

Remarks:

4-hour exposure

Basis:

animal #1

Time point:

other: 1/24 h

Score:

0

Results 4

Irritation parameter:

erythema score

Remarks:

4-hour exposure

Basis:

animal #1

Time point:

other: 1/24/48 h

Score:

2

Remarks on result:

other: a well-defined erythema

Results 5

Irritation parameter:

erythema score

Remarks:

4-hour exposure

Basis:

animal #1

Time point:

72 h

Score:

3

Remarks on result:

other: a marked ertythema

Results 6

Irritation parameter:

erythema score

Remarks:

4-hour exposure, mean of scores

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Irritant / corrosive response data:

The test item Biotox-1 is corrosive under these experimental conditions when applied topically to rabbit skin.

Any other information on results incl. tables

3 -minute exposure - Cutaneous examinations and mean values of the scores recorded for the animal (24, 48 and 72 hours)

Rabbit number	Dermal Irritation	Scores				Mean irritation score (1)
		1h	24h	48h	72h
		D1	D2	D3	D4
19	Erythema	0	1	1	0	0.7
	Oedema	0	0	0	0	0.0
	Other	C	C	C	0

(1) mean of scores on days 2, 3 and 4

h = hour

D = day

C = beige coloration of the skin

1-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal (24, 48 and 72 hours)

Rabbit number	Dermal Irritation	Scores				Mean irritation score (1)
		1h	24h	48h	72h
		D1	D2	D3	D4
19	Erythema	2	2	2	4	2.7
	Oedema	0	2	2	2	2.0
	Other	C	C	C	ZB

(1) mean of scores on days 2, 3 and 4

h = hour

D = day

C = beige coloration of the skin

ZB = brownish area similar to a severe burn of the skin

4-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal (24, 48 and 72 hours)

Rabbit number	Dermal Irritation	Scores				Mean irritation score (1)	Interpretation (+) (-)
		1h	24h	48h	72h
		D1	D2	D3	D4
19	Erythema	2	2	2	3	2.3	(+)
	Oedema	0	0	1	1	0.7	(-)
	Other	C	C	C	C/S

(1) mean of scores on days 2, 3 and 4

h = hour

D = day

(+) = irritant according to E.E.C. criteria

(-) = non-irritant according to E.E.C. criteria

S = dryness of the skin

C = beige coloration of the skin

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item BIOTOX-21 is corrosive when applied topically to rabbits. According to the classification criteria laid down in 67/548/EEC the test item should be classified as corrosive and assigned the symbol C, the indication of danger "Corrosive" and the risk phrase R34 "Causes burns". Under the Regulation EC No 1272/2008 (CLP) the corresponding hazard statement is H314 "Causes severe skin burns and eye damage".

Executive summary:

The potential of the test item BIOTOX-21 to induce skin irritation was evaluated in rabbits according to OECD (No. 404) and EC (2004/73/EC B.4) guidelines and in compliance with GLP. The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. As the test item showed corrosive properties on first animal, the study was considered complete and the test item was not evaluated on other animals. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated. The interpretation of results was carried out according to the classification criteria laid down in 67/548/EEC.