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Diss Factsheets

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 guidelineopen allclose all
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 (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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