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:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data, List V
Author:
Smyth H.F.Jr. et al.,
Year:
1954
Bibliographic source:
Arch. Ind. Hyg. Occup. Med., Vol.10, 61-68

Materials and methods

Principles of method if other than guideline:
Penetration of rabbit skin was estimated by a technique closely to the one-day cuff method of Draize and associates, using groups of four male albino rabbits weighing 2.5 to 3.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious plastic film. The animals were immobilized during the 24 hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14 day observation period.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
430 mg/kg bw
Remarks on result:
other: conversion into mg/kg is based on the density of 0.86 g/cm3 (according to BASF internal data).
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
A dermal LD50 value for propylenediamine of 0.5 ml/kg bw, equivalent to 430 mg/kg bw (based on a density of 0.86 g/cm³) was reported for rabbits.
Executive summary:

Penetration of rabbit skin was estimated by a technique closely to the one-day cuff method of Draize and associates, using groups of four male albino rabbits weighing 2.5 to 3.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an impervious plastic film. The animals were immobilized during the 24 hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14 day observation period. No data regarding mortality, clinical signs and body weight changes are given. The reported LD50 for the penetration of rabbit skin is 0.5 ml/kg bw.