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

Skin sensitisation

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Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

Not applicable

Justification for non-LLNA method:

The study was performed before the OECD guideline 429 was used as standard method for regulatory purposes.

Test material

Test material information

Constituent 1

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Challenge

Route:

epicutaneous, occlusive

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10 %

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10 %

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

10 %

No. with + reactions:

1

Total no. in group:

10

Clinical observations:

Dryness of skin

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Dryness of skin.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

10 %

No. with + reactions:

1

Total no. in group:

10

Clinical observations:

Dryness of skin

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Dryness of skin.

Results 5

Group:

positive control

Remarks on result:

positive indication of skin sensitisation

Any other information on results incl. tables

Table 1: range-finding test by intradermal route

Animal number	Concentration of the test item % (w/w)	Scoring after treatment
		24 hours	48 hours	6 days
female 301	10 + FCA	I	A	A
	10	LI	I	I
	5 + FCA	I	A	A
	5	LI	I	I
female 302	10 + FCA	I	A	N
	10	I	I	A
	5 + FCA	I	A	A
	5	LI	I	I
male 305	1 + FCA	I	I	A
	1	LI	LI	LI
	0.1 + FCA	I	I	I
	0.1	LI	LI	LI
female 306	1 + FCA	I	I	A
	1	LI	LI	LI
	0.1 + FCA	I	I	I
	0.1	LI	LI	LI

FCA : mixture Freund's Complete Adjuvant/0.9% NaCl (50/50, v/v)

N : necrosis

I : irritation

LI : slight irritation

A : crusts

Table 2: Range-finding test by topical application

Under the conditions of the induction phase

Animal number	Concentration of the test item % (w/w)	Scoring after removal of the dressing
		24 hours	48 hours
female 303	50	3/A	3/A/Oe
female 304	25	3/A	LS/A/Oe
male 307	10	0	0
female 308	5	0	0

A : crusts

LS : scoring masked by dryness of the skin

Oe : oedema

Under the conditions of the challenge phase

Animal number	Concentration of the test item % (w/w)		Scoring after removal of the dressing
			24 hours	48 hours
female 301	50	RF	2	2/S
	25	LF	1	0
female 302	50	RF	2	2/S
	25	LF	1	1
male 305	10	RF	0	0
	5	LF	0	0
female 306	10	RF	0	0
	5	LF	0	0

RF : right flank

LF : left flank

S : dryness of the skin