Poly(oxy-1,2-ethanediyl), α-(carboxymethyl)-ω-hydroxy-, C16-18 (even numbered) and C18-unsatd. alkyl ethers

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 August 1988 to 1st September 1988

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

GLP compliance:

yes

Test type:

standard acute method

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) limited
- Age at study initiation: young adult, 4-7 weeks
- Housing: in single sex groups of five
- 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 (%): 59-74
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The supplied material was formulated in distilled water to archive a dose volume of 10 mg/Kg bodyweight at a dose level of 2000 mg/L

Doses:

dose level: 2000 mg/kg bw; dose volume of 10 mL/kg bodyweight

No. of animals per sex per dose:

Five male and five female animals

Control animals:

no

Details on study design:

All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed on Day 1, 8 abd 15.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

no mortalities

Mortality:

No animals died

Other findings:

Piloerection was observed in all animals from within 30 minuts of dosing until four hours.
Transient peribuccal staining was additionally present in one female within 30 minuts of dosing. No other effects of observed during the study. At necropsy a white waxy plug was observed in the bladder of one male and fluid distension of the uterus was noted in one female.

Bodyweights - Individual values

Dose level mg/kg	Animal nº	Sex	1 Day (g)	8 Day (g)	15 Day (g)	change in bw Day 1 -15
2000	1	M	122	194	246	124
2000	2	M	122	171	220	98
2000	3	M	124	177	223	99
2000	4	M	122	186	249	127
2000	5	M	119	177	221	102
2000	Mean	M	122	181	232	110
2000	S.D	M	1.8	9.0	14.4	14.3
2000	6	F	116	148	166	50
2000	7	F	115	149	173	58
2000	8	F	134	166	190	56
2000	9	F	130	156	180	50
2000	10	F	108	142	166	58
2000	Mean	F	121	152	175	54
2000	S.D	F	10.9	9.2	10.2	4.1

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced no significant toxic effects when administred orally at a dose level of 2000 mg/kg

Executive summary:

The test material was administered orally, as a single dose of 2000 mg/kg bw, by gavage to a group of five male and female albino rats. Animals were observed for a fourteen day period for clinical signs after which surviving animals were killed and a gross necropsy undertaken.

Piloerection was observed in all animals during the four hours immediately following dosing. No other significant effects were noted throughout the study. At necropsy a white waxy plug was observed in the bladder of one male.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1999-09-23 to 1999-10-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

updated guideline, adopted: Feb 24, 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31, 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: males mean 207 g / females mean 191 g
- Fasting period before study: 16 hours before to 3 - 4 hours after treatment
- Housing: macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff" R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50±20 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 1999-09-29 to 1999-10-13

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

dose range finding study: 500, 1000, 2000 mg/kg bw;
definitive study: 2000 mg/kg bw

No. of animals per sex per dose:

dose range finding study: 1 m / 1 f per dose
definitive study: 5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once.
During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Preliminary study:

Comprehensive description of clinical signs:
After administration of 2000 mg/kg body weight the animaIs showed stilted and uncoordinated gait on application day. The animals of the 1000 and 500 mg/kg dose group showed no clinical signs.

Cornprehensive description of macroscopic findings:
The animals killed at the end of the observation period showed no macroscopically visible changes.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

no mortality

Mortality:

No mortality occurred during the whole study.

Clinical signs:

other: The following clinical signs were observed on application day after test substance administration: uncoordinated and stilted gait.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of the test substance for male and female rats is greater than 2000 mg/kg body weight.

Executive summary:

In an acute oral toxicity study according to OECD guideline 401 (24 February 1987) and EU method B.1 (31 July 1992), 10 fasted approx. 6-10 weeks old Sprague Dawley (SD) rats (5 male and 5 female) were given an oral dose of Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid as a 20% solution in sesame oil at a limit dose of 2000 mg/kg bw. Animals were then observed for 14 days.

No animal died during the observation period. On application day after the administration uncoordinated and stilted gait was noted for some animals.

The body weight development of the animals was within normal range for animals of the same age and strain. The necropsy at the end of the observation period showed no macroscopically visible test substance related pathologic organ findings.

Oral LD50 Males and Females > 2000 mg/kg bw

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

OECD guideline studies, no deviations, GLP

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

other:

Endpoint conclusion

Endpoint conclusion:

no study available