Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well described, acceptable study.

Data source

Reference
Reference Type:
publication
Title:
Comparative toxicity of synthetic and natural glycerin
Author:
Hine C. et al.
Year:
1953
Bibliographic source:
Arch. Ind. Hyg. Occup. Med. 7: 282-291

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
No information
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Synthetic glycerol was a commercial product manufactured by Shell Chemical Corporation. Purity 99.5%. The impurities contained mostly water, and there was no spectroscopic evidence of benzene or naphtalene nuclei or any other aromatic compounds. The only specific contaminants have been glycerin polymers and glyceraldehyde.

Natural glycerin was selected at random from market stock.

Each specimen was analysed acc. to the "Pharmacopoeia of the US" and chloride values were determined. There were minor differences between the natural and synthetic glycerin - the residue on ignition, the content of fatty acids and esters was grater for natural glycerin.

Test animals

Species:
rabbit
Strain:
other: albino rabbit
Sex:
male
Details on test animals and environmental conditions:
The rabbits were obtained from the local suppliers and were quarantined for 2 weeks prior to use.

No information provided

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
see below
Duration of exposure:
8 hours
Doses:
6.25 - 18.7 g/kg b.w.
No. of animals per sex per dose:
six rabbits (3.0 +/- 0.5 kg) were treated with 6.25 - 18.7 g/kg of glycerin.
Control animals:
not required
Details on study design:
The rabbits were obtained from the local suppliers and were quarantined for 2 weeks prior to use.

The rabbits whose trunks were shaved 24 hours previously were immobilised in the multiple rabbit holder. Glycerin was poured over the dorsal region and gently rubbed in with a glass rod. The glycerin was held in contact with skin for 8 hours by means of a rubber dam.
Statistics:
No information

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 18.7 other: g/kg
Mortality:
None
Clinical signs:
None
Body weight:
No effects
Gross pathology:
No effects

Any other information on results incl. tables

The results were negative; apparently neither glycerin was absorbed in quantities sufficient to produce a pharmacologic effect.

Applicant's summary and conclusion

Conclusions:
Acute dermal toxicity of natural and synthetic glycerin was studies in six rats. After 8 hour exposure to 6.25 - 18.7 g/kg glycerin, no effects of acute toxicity were observed. Neither glycerin was absorbed in quantities sufficient to produce a pharmacologic effect.