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

Endpoint summary

Description of key information

LD50>2000 mg/kg bw in a limit test by oral route.
LD50>2000 mg/kg bw in a limit test by dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

None

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Well conducted and described study in accordance with GLP and OECD guideline 423 without any deviation.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Principles of method if other than guideline:

Not applicable

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Type of coverage:

semiocclusive

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Table 1: individual bodyweights

Dose (mg/kg)	Sex	Animals	Day 1	Body weight gain	Day 8	Body weight gain	Day 15
2000	Male	01	270	39	309	53	362
		02	248	53	301	65	366
		03	216	43	259	51	310
		04	253	56	309	69	378
		05	247	40	287	50	337
		Mean	247	46	293	58	351
		SD	20	8	21	9	27
2000	Female	06	237	0	237	23	260
		07	244	2	246	8	254
		08	234	12	246	22	268
		09	235	13	248	18	266
		10	249	-2	247	7	254
		Mean	240	5	245	16	260
		SD	6	7	4	8	7

Table 2: cutaneaous reactions

Time	Animals		Cutaneous reactions
	Males	Females
D 2	5/5	5/5	None
D 3	4/5		Discrete erythema
	1/5	2/5	Moderate erythema
		2/5	Severe erythema
		1/5	Moderate erythema, crusts
D 4		2/5	Dryness of the skin,moderate erythema
		3/5	Moderate erythema
	2/5		Dryness of the skin,discrete erythema
	3/5		None
D 5	2/5	1/5	Dryness of the skin
		1/5	Moderate erythema
		3/5	Dryness of the skin,discrete erythema
	3/5		None
D 6	2/5	2/5	Dryness of the skin
	3/5		None
		3/5	Dryness of the skin, discrete erythema
D 7	2/5	4/5	Dryness of the skin
	3/5	1/5	None
D 8 and D 9	1/5		Crusts, dryness of the skin
	4/5	3/5	Dryness of the skin
		2/5	None
D 10 and D 11	5/5	3/5	Dryness of the skin
		2/5	None
D12 to D 15	5/5	5/5	None

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP study conducted in compliance with international guidelines without any deviation.

Additional information

In an acute oral class method toxicity study performed in accordance with GLP and OECD guideline 423, no mortality and no clinical signs were observed in Sprague Dawley rats given a single oral dose of Chimexane NV in purified water at the limit test dose of 2000 mg/kg bw.

In an acute dermal toxicity study performed in accordance with GLP and OECD guideline 402, no mortality was observed in Sprague Dawley rats given a single dose of Chimexane NV at the limit test dose of 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Only one study available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint
The test substance is most of the time a pasty solid, so the potential for the generation of inhalable forms is unlikely. The substance is liquid and around 100°C during conditioning phase; sufficient RMM are already used during this phase, as workers are protected with intensive gloves, protective clothings and headgear as well as a local extraction ventilation. In addition, no acute toxic effects were identified in acute toxicity studies by oral and dermal routes. As this route of exposure is not significant and that no acute toxic effects are expected, an acute inhalation toxicity study is not deemed necessary.

Justification for selection of acute toxicity – dermal endpoint
Only one study available for this endpoint

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in rats therefore Chimexane NV does not need to be classified for acute toxicity according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (EC) N° (1272/2008).