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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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
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

Constituent 1
Chemical structure
Reference substance name:
Docusate sodium
EC Number:
209-406-4
EC Name:
Docusate sodium
Cas Number:
577-11-7
Molecular formula:
C20H38O7S.Na
IUPAC Name:
sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate
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:
other: Signs of intoxication: none noted. Skin iritation: fissuring, desquamation, coriaceousness was noted. Rabbits noted pulling fur out.
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 .