Oligomerisation products of ethylene oxide with reaction products of rape oil and ethanolamine

Endpoint summary

Description of key information

No mortalities occurred after oral and dermal exposure, while an inhalation study is waived. All available studies were done according to corresponding guidelines under GLP conditions.

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

Study period:

From 5 August 1991 to 28 October 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 197-218 g
females: 155-169 g
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/Kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No mortality

Mortality:

No mortality occurred during the study period

Clinical signs:

other: No clinical signs of ill health or behavioural changes were seen during the test

Gross pathology:

Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities

INDIVIDUAL ANIMAL OBSERVATIONS - MALES

Dose Level (mg/kg)	Observations	Number showing effects during day of exposure (hours)			Number showing effects during day of observation														Total mortality
		0,05	2,1	4,15	2	3	4	5	6	7	8	9	10	11	12	13	14	15
2000	No abnormalities	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5
	Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5

INDIVIDUAL ANIMAL OBSERVATIONS - FEMALE

Dose Level (mg/kg)	Observations	Number showing effects during day of exposure (hours)			Number showing effects during day of observation														Total mortality
		0,05	2,1	4,15	2	3	4	5	6	7	8	9	10	11	12	13	14	15
2000	No abnormalities	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5	5
	Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/Kg body weight.

Executive summary:

This study was entitled "Assessment of acute oral toxicity with the substance in the rat". The study was carried out in accordance with the OECD Guideline No. 401, “Acute Oral Toxicity” and EEC Directive 84/449/EEC, Par B.1, “Acute Toxicity-Oral”. No clinical signs of ill health or behavioural changes were observed during the study and no macroscopic abnormalities were seen at necropsy. The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/kg body weight.

The substance cannot be classified and has no obligatory labelling requirement.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Study is reliable without restrictions.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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

Study period:

23/10/2007-6/11/2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River (UK) Ltd, Margate, Kent, UK
- Housing: individually during the 24-hour exposure period and in group of five, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females and 5 males per 2000 mg/kg each of them

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality.

Mortality:

There were no deaths

Clinical signs:

other: There were no signs of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy

Dose Level 2000 mg/kg

		Effect		Notted		after		initiation		of		exposure		(Days)
	Observation	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1 - 0 Male / 2 - 0 Female	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1 -1 Male / 2 -1 Female	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1 -2 Male / 2 - 2 Female	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1 - 3 Male / 2 - 3 Female	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1 - 4 Male / 2 - 4 Female	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxciity" and method B3 Acute toxicity (Dermal). A group of ten animals (five males and five females) was given a single, 24 -hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Moratlity: There were no deaths

Clinical observations: There were no signs of systemic toxicity .

Dermal irritation: There were no signs of dermal irritation.

Bodyweight: All animals showed expected gains in bodyweight over the study period.

Necropsy: No abnormalities were noted at necropsy

The acute dermal median lethal dose LD50 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Study is reliable without restrictions.

Additional information

Acute oral toxicity:

The oral LD50 value of the substance in rates of either sex was established as exceeding 2000 mg/kg body weight. Neither mortalities nor clinical signs were observed during the study.

 

Acute inhalation toxicity:

No study data available. Inhalation was not tested as this is not a likely way of entry/route of exposure.

 

Acute dermal toxicity:

The acute dermal toxicity median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. Neither mortalities norclinical signs were observed during the study.

Justification for selection of acute toxicity – oral endpoint
Sole study available

Justification for selection of acute toxicity – dermal endpoint
Sole study available

Justification for classification or non-classification

- oral toxicity:

Based on the above stated assessment of the acute oral toxicity of the test item, the results from reliable study are above the threshold value given in the CLP Regulation. Therefore the test item does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity of the test item, the results from reliable study are above the threshold value given in the CLP Regulation. Therefore the test item does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- inhalation toxicity:

No inhalation studies are available and due to exposure considerations the conduct of studies and the classification and labelling for this endpoint is deemed not to be necessary.