Reaction mass of glycerol, glycerol 1-formate, glycerol 2-formate, glycerol 1,2-diformate, glycerol 1,3-diformate and glycerol triformate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

This endpoint study record is part of a Weight of Evidence approach comprising of read-across from six analogue source substance studies. The results of the read-across studies agree as to the acute oral toxicity and are sufficient to fulfil the information requirements as further explained in the provided acute toxicity endpoint summary.

Data source

Reference

Reference Type:

publication

Title:

THE SINGLE DOSE TOXICITY OF SOME GLYCOLS AND DERIVATIVES

Author:

Smyth HF, Seaton J & Fischer L

Year:

1941

Bibliographic source:

Journal of Industrial Hygiene and Toxicology, 23(6): 259-268

Materials and methods

Test guideline

Guideline:

other: Pre-guideline oral gavage

Principles of method if other than guideline:

Test material was administered as a 50% solution in water at various doses to rats. Animals were monitored for two weeks post-dosing for mortality. Gross pathologic examination was conducted only on rats whose death was inconsistent with that of the others in the group.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

Propane-1,2,3-triol

Details on test material:

GLYCERINE USP grade

Specific details on test material used for the study:

Reported as Glycerol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Albino male Wistar strain rats weighing 90-120 g when dosed. The animals received an adequate diet of Purina chows, supplemented by fresh vegetables, and water was freely available. The diet was given in the afternoon, and the doses administered the following morning in most cases.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The maximum dose was a 50% solution in water. The amount administered varied but was not stated in paper. Doses produced no mortality to complete mortality.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

Groups of 10 male rats/dose were dosed by oral gavage and the mortality for the 14 day post-dosing period determined for each dose level.

Statistics:

method of probits

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

27 500 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met