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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-hydroxyethoxy)propyl prop-2-enoate; 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]butoxy]ethoxy]propyl 3-(dibutylamino)propanoate
EC Number:
605-658-8
Cas Number:
173011-06-8
Molecular formula:
Not specified UVCB - Reaction product of ethoxylated/propoxylated (0-6 EO; 0-6 PO) propylidenetrimethanol with acrylic acid and dibutylamine (acrylic acid : dibutylamine = 3:1)
IUPAC Name:
2-(2-hydroxyethoxy)propyl prop-2-enoate; 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]butoxy]ethoxy]propyl 3-(dibutylamino)propanoate
Details on test material:
- Name of test material (as cited in study report): Laromer PO 83 F
- Physical state: liquid
- Lot/batch No.: P N 2/93

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight (150 - 300 g)
- Fasting period before study: 16 h before administration
- Housing: single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet 343, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
No abnormality.
Body weight:
The expected body weight gain has been observed in the course of the study.
Gross pathology:
No pathologic findings.

Applicant's summary and conclusion