Poly[oxy[(hydroxymethyl)-1,2-ethanediyl]], .alpha.-dodecyl-.omega.-hydroxy-

Skin irritation / corrosion

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Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Housing temperature and area of application not reported.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Housing temperature and area of application not reported.

Principles of method if other than guideline:

Not applicable

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: After 3 min exposure

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: After 3 min exposure

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: After 4 h exposure

Other effects:

A yellow coloration of the skin also observed at the 24 h and 48 h readings after both exposures.

Any other information on results incl. tables

Table 1: 3-minute exposure - Cutaneous examinations and mean values of the scores

Dermal irritation	Scores				Mean irritation score
	1 h	24 h	48 h	72 h
erythema	0	0	0	2	0.7
oedema	0	0	0	3	1.0
other	none	Yellow coloration	Yellow coloration	none

Table 2: irritation scores for the 14-day observation period after 3-min exposure

Dermal irritation	Scores
	D5	D6	D7	D8	D9	D10	D11	D12	D13	D14
erythema	2	2	2	1	1	1	1	1	1	0
oedema	2	2	2	0	0	0	0	0	0	0
other	none	none	Dryness of the skin	Dryness of the skin	Dryness of the skin	Dryness of the skin	none	none	none	none

Table 3: 4-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal

Dermal irritation	Scores				Mean irritation score
	1 h	24 h	48 h	72 h
erythema	1	1	2	Scoringmasked by necrosis	(2) (not calculated)
oedema	0	0	3	4	2.3
other	none	Yellow coloration	Yellow coloration	none