Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predates OECD guidelines and GLP, minor restrictions in design and reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
Neat tripropylene glycol was applied to the intact skin of the trunk of male albino rabbits for 24 h under occlusive dressing.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tripropylene glycol
- Substance type: organic
- Analytical purity: not specified
- Lot/batch No.: 06827
- Identification: S-145541
- CHF sample No: 37-61
- Date of receipt: 2-8-74

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
The nonfasted animals were maintained on appropriate Rockland diets and water ad libitum except during period of manipulation or confinement. Rabbits were 3 to 5 months of age.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test substance was applied undiluted under impervious sheeting on the clipped intact skin of the trunk. Animals were immobilized for 24 hour contact period.
Duration of exposure:
24 h
Doses:
16.0 ml/kg bw
No. of animals per sex per dose:
5 males/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 was calculated by the moving average method based on a 14-day observation period.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 320 mg/kg bw
Remarks on result:
other: Value in mg/kg bw was calculated based on the LD50 > 16 mL/kg bw and the relative density of the substance of 1.02.
Mortality:
There were no mortalities.
Clinical signs:
There were no clinical signs.
Body weight:
Weight change: -45, 75, 140, 145 and 345 g
Gross pathology:
Livers mottled and acini prominent, spleens congested, kidneys pale and mottled.

Applicant's summary and conclusion