Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
This endpoint study record is part of a Weight of Evidence approach comprising data of the constituents composing the UVCB substance "Amaryllidaceae, Allium Cepa L. (fresh bulb), Rutaceae, Citrus Limon (L.) Burm. F. (fresh pulp), extract, sodium chloride" constituents.

Data source

Reference
Reference Type:
review article or handbook
Title:
Sax's Dangerous Properties of Industrial Materials. 11th Edition.
Author:
Lewis, R.J.
Year:
2004
Bibliographic source:
Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 3238

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
this is a published data, from a peer reviewed data handbook.
However, no guideline is mentionned in the summary.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 3 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

A weight of evidence approch was used on to assess the acute toxicity of the UVCB substance "Amaryllidaceae, Allium Cepa L. (fresh bulb), Rutaceae, Citrus Limon (L.) Burm. F. (fresh pulp), extract, sodium chloride".

A bibliographic search was performed on the constituents composing this substance:

-Sodium Chloride 231-598-3, 40 -50%; oral EC 50 (rat) = 3000 mg/kg

-Monosaccharides (mainly glucose EC 200-075-1 and fructose EC 200-333-3) 25 -30%

Glucose, oral EC 50 (rat) =25,800 mg/kg

Fructose,oral EC 50 (rat) =4000 mg/kg

-Disaccharides (mainly saccharose EC 200-334-9) 10 -20%

Saccharose,oral EC 50 (rat) =29,700 mg/kg

-Citric acid EC 201-069-1 , approx 1,5%; oral EC 50 (rat) = 11700mg/kg

 

As a precautionary principle, the LD50 of the substance should be based on the LD50 of NaCl which is the lowest one:
LD50 Rat oral 3000 mg/kg