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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited report with only basic information on test substance purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: mobile liquid
Details on test material:
- Name of test material (as cited in study report): Surfactant E-268 (anionic)
- Sample No. CHF 34-133
- Commercial name: Aerosol A-268

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2632 (mean)

Administration / exposure

Type of coverage:
other: covered (no further details given)
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No details
Duration of exposure:
No data
Doses:
10 mL/ kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weight was measured before dosing and at sacrifice
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs were recorded (no further details on frequency)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Test substance tested as received, as 50% aqueous formulation. This corresponds to an LD50 of > 5 mL/kg bw for Disodium iso-decylsulfosuccinate when tested in this formulation.
Mortality:
One animal died on day 5 after dosing.
Clinical signs:
No clinical signs noted.
Body weight:
No change in mean body weight noted.
Gross pathology:
Livers and kidneys appeared congested and mottled.

Applicant's summary and conclusion

Conclusions:
In an acute dermal toxicity test with 5 male rabbits, an LD50 > 10 mL/kg bw was found for Surfactant E-268 (anionic). The test substance was tested as received, as 50% aqueous formulation of disodium 4-isodecyl sulfosuccinate. The LD50 thus corresponds to an LD50 of > 5000 mg/kg bw for disodium 4-isodecyl sulfosuccinate when tested in this formulation.