Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature available (analytical purity of test substance not reported, limited documentation).

Data source

Reference
Reference Type:
secondary source
Title:
Handbook of Pharmaceutical Excipients
Author:
Rowe, R.C.
Year:
2009
Bibliographic source:
p549 - p553

Materials and methods

Principles of method if other than guideline:
Determination of intravenous LD50.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan monolaurate, ethoxylated
EC Number:
500-018-3
EC Name:
Sorbitan monolaurate, ethoxylated
Cas Number:
9005-64-5
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
Sorbitan monolaurate, ethoxylated (1-6.5 moles ethoxylated)
Details on test material:
- Name of test material (as cited in study report): Polysorbate 20
- Analytical purity: not given

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
intravenous
Vehicle:
not specified
Doses:
1420 mg/kg
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 420 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion