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:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1938

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Test material was administered dermally to groups of guinea pigs. The material remained in dermal contact for 4 days. Animals were observed for two weeks after removal of the dermal bandage
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
No additional information available.

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No additional information available.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The hair was removed with electric clippers from a band of skin about three inches wide, completely encircling the animal between the fore and hind legs. One day was then allowed for healing of any small accidental skin nicks. Then the animal was weighed and the dose calculated in terms of millitliters of material per kilo body weight. A piece of three-inch adhesive tape was cut, long enough to encircle the clipped area about twice. On this a flat pad of absorbent cotton was laid, thick enough and large enough to retain the entire calculated dose. For the larger doses, this cotton pad was about 2 x 10 cm., and the full thickness of cotton in a standard one pound roll. For smaller doses the pad was made proportionately smaller and thinner. This cotton pad then received the measured dose and the tape and pad were wrapped about the pig, covering the clipped area, the cotton over the abdomen. About three, or in most cases four days, the tape was removed without the use of solvents, the skin area observed for signs of irritation other than that due to the tape.
Duration of exposure:
three or four days
Doses:
16, 40, 50 and 60 ml/kg
No. of animals per sex per dose:
5 guiinea pigs (mixed sex) were dosed at 50 and 60 ml/kg, 8 guinea pigs were dosed at 40 ml/kg and 1 guinea pig was dosed at 16 ml/kg. One male was dosed with 16 ml/kg, 3 males and 5 females were dosed with 40 ml/kg, 1 male and 4 females were dosed with 50 ml/kg and 4 males and 1 female were dosed with 60 ml/kg.
Control animals:
not specified
Details on study design:
Following removal of the bandage the animals were kept under observation for two weeks, or until they died.
Statistics:
No additional information available.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
45 mL/kg bw
Based on:
test mat.
Mortality:
See Table below
Clinical signs:
After about 12 hours the animals became accustomed to the restriction of the bandage and ate and in general behaved as usual, those having large doses being weak with low body temperature and dying; those with small doses apparently not being affected.

No evidence of skin irritation from the dose in the cotton pad was observed.
Body weight:
At 60 ml/kg, the body weight of the surviving male was 130 gram greater than on the day of dosing.
At 60 ml/kg, the body weight of the surviving female was 3 grams less than on the day of dosing.

At 50 ml/kg, the body weight of the surviving female was 3 grams greater than on the day of dosing.

At 40 ml/kg, the body weight of the two surviving males was 8 and 34 grams less than on the day of dosing.
At 40 ml/kg, the body weight of the three surviving females was -12, -38 and 14 grams from the predosing level.

At 16 ml/kg, the body weight of the surviving male was 23 grams less than on the day of dosing.
Gross pathology:
No additional information available.
Other findings:
No additional information available.

Any other information on results incl. tables

Mortality

 Dose Level (ml/kg)  Number dosed  Number survived
16   1  0
 40  8  3
 50  5  4
 60  5  3

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute dermal toxicity of glycerin was examined in guinea pigs. The dermal LD50 was determined to be 45 ml/kg (56,750 mg/kg) in guinea pigs.
Executive summary:

The acute dermal toxicity of glycerin was examined in guinea pigs. The dermal LD50 was determined to be 45 ml/kg (56,750 mg/kg) in guinea pigs.