Glycerol, propoxylated, esters with acrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 15, 1992 to February 26, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol, propoxylated, esters with acrylic acid

EC Number:

500-114-5

EC Name:

Glycerol, propoxylated, esters with acrylic acid

Cas Number:

52408-84-1

Molecular formula:

(C3H6O)m(C3H6O)n(C3H6O)oC12H14O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.',.alpha.''-1,2,3- propanetriyltris[.omega.-[(1-oxo-2-propenyl)oxy]]-

Specific details on test material used for the study:

- Lot/batch No.: OF-20406

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) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5- 8 wk
- Weight at study initiation: Males: 139 - 156 g; Females: 121 - 144 g
- Fasting period before study: Yes
- Housing: Solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum, Rat and Mouse Expanded Diet No.1, Special Diet Services Ltd.
- Water: ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19- 23 °C
- Humidity: 47- 67%
- Air changes: 15/h
- Photoperiod: 12 h dark / 12h light

IN-LIFE DATES: From: 1992-06-15 to: 1992-07-07

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Dose volume: 1.91 mL/kg bw
Specific gravity: 1.050

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Range finding study: 1 animal/sex/dose
Main study: 5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Deaths and overt signs of toxicity were recorded 0.5, 1, 2 and 4h after dosing and subsequently once daily for 14 d. Body weight recorded on Day 0, 7 and 14.
- Necropsy of survivors performed: Yes for the main study; no necropsy in range finding study animals
- Other examinations performed: Behavioural and clinical signs, body weight, gross lesions, mortality and any other toxicological effects

Statistics:

No data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities observed in range finding and main study

Clinical signs:

other: No clinical signs observed in range finding and main study

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met