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

Endpoint summary

Description of key information

Signs of corrosive effects were observed in a skin irritation study in one New-Zealand white rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Housing temperature and area of application not reported.

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

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

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

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

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.

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a GLP study conducted according to OECD guideline 404, a New-Zealand white rabbit treated with 0.5 mL of Chimexane NV for 4 h showed necrosis associated with a severe oedema on the whole treatment site on Day 4.

According to ANNEX VII column 2 of the REACH regulation, no study was needed to assess eye irritation as Chimexane NV is classified as corrosive.

When taking into account the corrosive properties of CHIMEXANE NV on skin, it is considered that it can cause severe damages to the eye.

Justification for selection of skin irritation / corrosion endpoint:
Only one study assessing the irritant potential of the substance.

Justification for selection of eye irritation endpoint:
One skin irritation study showing corrosive effects on skin is available. A waiver is therefore submitted for this endpoint.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

As corrosive effects were observed on the skin of a New-Zealand white rabbit exposed by dermal route to Chimexane NV for 4 h, Chimexane NV is classified as corrosive (C; R34) according to the Directive 67/548/EC and category 1C according to CLP Regulation (EC) N° (1272-2008).

No study for eye irritation was performed; when taking into account the corrosive properties of CHIMEXANE NV on skin, it is considered that it can cause severe damages to the eye.