Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted equivlent to international guidelines, but predates GLP conditions. The study was conducted in a renomated laboratory and to the standards possible at the time of testing.
Justification for type of information:
Data has been read across from a structurally similar substance in a category approach. See further discussion in the read across justification attached.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
male animals only
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): Aerosol® OT-100, Sodium Dioctyl Sulfosuccinate
- Physical state: white, waxy solid
- Analytical purity: >97%



Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male

Administration / exposure

Type of coverage:
other: covered
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dermal application to clipped unabraded skin
Duration of exposure:
24 hours
Doses:
10 mL/kg bw; equivalent to 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
Signs of intoxication: none noted.
Skin iritation: fissuring, desquamation, coriaceousness was noted. Rabbits noted pulling fur out.
Body weight:
Mean weight at initiation: 2290 g
Mean weight at termination: 2551 g
Gross pathology:
No gross pathology was observed
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50>10000 mg/kg, dosed as received.
Executive summary:

Docusate sodium dosed dermally in male rabbits at 10000 mg/kg bw did not lead to mortality. Clinical observations included some skin iritation (fissuring, desquamation, coriaceousness, pulling fur out), however no signs of intoxication or gross pathological findings were noted .