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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

EC Number:

611-563-2

Cas Number:

57635-48-0

Details on test material:

- Physical state: clear yellow liquid

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.