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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:
29 Sep 2005 - 06 Oct 2005
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test substance applied as received (formulation with at least 20% disodium isodecyl sulfosuccinate). The study can be used as supportive evidence: no toxicity is seen up to 2000 mg/kg bw of the formulation. However, the tested formulation contains several additional compounds, which could influence the acute effects of the disodium isodecyl sulfosuccinate. Furthermore, since the maximum concentration that should be tested to comply with C&L is 2000 mg/kg, the test is not considered sufficient to cover this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only males used; test substance held onto skin occlusively (instead of semi-occlusively); observation period only 7 days (instead of at least 14 days).
GLP compliance:
yes
Test type:
other: no guideline followed
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium C-isodecyl sulphonatosuccinate
EC Number:
253-452-8
EC Name:
Disodium C-isodecyl sulphonatosuccinate
Cas Number:
37294-49-8
Molecular formula:
C14H26O7S.2Na
IUPAC Name:
disodium C-isodecyl sulphonatosuccinate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): XSM 2697 (CT-833-05)
- Aqueous solution with at least 20% disodium isodecyl sulfosuccinate
- Substance type: Organic
- Physical state: Clear liquid
- Specific gravity: 1.17
- Storage conditions: Room temperature
- Expiration date of the lot: 31st August 2006
- pH: 5-6

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Age at study initiation: appr. 3 months
- Weight at study initiation: 2.8-3.4 kg
- Fasting period before study: no
- Housing: 1/cage in suspended wire cages
- Diet: PMI rabbit chow, daily portions
- Water: ad libitum
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature-controlled animal room (not further specified)
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 Sep To: 06 Oct 2005

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: 1, 4 and 24 hours postdose, daily afterwards (mortality, toxicology and pharmacological effects); bodyweights determined pretest and at test termination
- Necropsy of survivors performed: no
Other examinations performed: dermal responses (24 hours and on day 7)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks:
XSM 2697
Remarks on result:
other: The substance was dosed as supplied, with a concentration of at least 20% disodium isodecyl sulfosuccinate.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 400 mg/kg bw
Based on:
act. ingr.
Remarks:
in formulation at appr. 20%
Remarks on result:
other: The substance was dosed as supplied, with a concentration of at least 20% disodium isodecyl sulfosuccinate.
Mortality:
No mortality occurred.
Clinical signs:
No clinical effects were noted.
Body weight:
No changes in body weight gain were found.
Other findings:
Dermal effects were moderate on day 1 and ranged from absent to very slight on day 7.

Applicant's summary and conclusion

Interpretation of results:
other: data insufficient for classification purposes
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity test with 5 male rabbits, no mortality was observed at 2000 mg/kg bw XSM 2697 (an aqueous formulation with ≥20% disodium isodecyl sulfosuccinate). The LD50 of disodium isodecyl sulfosuccinate in this formulation is thus found to be >400 mg/kg bw when tested in this formulation.