Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1953
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed prior to OECD guideline availability and GLP but follows basic scientific principles later adopted by OECD.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1953
Report Date:
1953

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
light yellow powder with no characteristic odor and insoluble in water

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
Animals were housed individually during study and observation period.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Application to shaved abdominal skin surface of white albino rabbits
Duration of exposure:
18-22 hours, followed by a five day observation period
Doses:
2, 4, 8 and 16 g/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Statistics:
no statistics was applied

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 000 mg/kg bw
Based on:
test mat.
Mortality:
One death at the 2 g/kg bw level occured and was probably associated with an intercurrent infection and not due to dermal application of the test material. Other than that no mortality occured.
Clinical signs:
Only mild skin irritation of short duration developed in 2 animals during the first 2 days of the study and only in animals of the lowest dose level.
Body weight:
not reported
Gross pathology:
Following necropsy and autopsy no significant gross findings were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD 50 (dermal, rabbit): > 16000 mg/kg bw
Executive summary:

In this study for dermal acute toxicity performed with male albino rabbits, no treatment related mortality was observed up to a dose of 16 g/kg bw. Thus the LD50 was set to be greater than 16 g/kg bw.

Only mild skin irritations were noted and only in 2 animals of the low dose group (2 g/kg bw). Also, one animal from this dose group died at day 4 of the observation period. Both observations, mild skin irritation and mortality of one test animal were obviously not treatment related as these occured at the low dose group tested and no skin irritation nor mortality was observed at the higher dose groups.