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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1988.02.24-1988.03.09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to internationally accepted test guidelines, and was considered to be reliable, adequate and relevant. The limit dose was reached for the active ingredient.
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-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
dose is higher
Principles of method if other than guideline:
The limit dose is 3000 mg/kg bw. instead of 2000 mg/kg bw. Taking into account the purity (70% sodium diisooctylsulfosuccinate), 2100 mg active ingredient/kg was given, which corresponds to the limit dose.
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
Constituent 2
Reference substance name:
formulated product containing 70% Docusate sodium
IUPAC Name:
formulated product containing 70% Docusate sodium
Details on test material:
- Name of test material (as cited in study report): MARLINAT DF 8
- Substance type: sulfosuccinic acid ester
- Physical state: liquid, clear
- Analytical purity: 70 % Diisoctylsulfosuccinat Natriumsalz
- Lot/batch No.:733470 (Chargen-Nr.)

Test animals

Species:
rat
Strain:
other: WISW (SPF TNO)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen
- Weight at study initiation: average 147 g (see Table 1)
- Fasting period before study: 16 hours
- Housing: 1-5 animals in Makrolon-cages Type III
- Diet: R10 Alleindiät für Ratten, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: public supply, ad libitum
- Acclimation period: 4 – 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C+-1°C
- Humidity (%):60% +- 5%
- Air changes (per hr): 15 air replacements/ hour
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: calculated at 2,83 mL /kg
DOSAGE PREPARATION (if unusual): undiluted

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:
3000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before administration (fasted), after 24 hours, 1 week and 2 weeks
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic pathology

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: MARLINAT DF 8
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 100 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality
Clinical signs:
other: All animals showed red brown lips and a slightly harsh skin 20-30 minutes after administration; one animal showed diarrhea 3-7 hours after administration. After 24 hours the skin was very harsh and the animals showed a squatting attitude; 4 animals showed
Gross pathology:
Dissection at the end of testing showed only in 1 animal with a partial bulge of the stomach mucosa.

Any other information on results incl. tables

 Table 1. Mean body weight evolution in g

Dosis mg/kg

Before administration (on an empty stomach) fasted

24 hours after administration

1 week after administration

2 weeks after administration

Increase of weight

3000

147,0

 

149,8

183,2

 

205,8

58,8

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of MARLINAT DF 8 was > 3000mg/kg body weight, corresponding with >2100 mg active ingredient/kg body weight.
Executive summary:

Acute toxicity testing in 5 male and 5 female rats showed that the LD50 of MARLINAT DF 8 was > 3000mg/kg body weight, corresponding with >2100 mg active ingredient/kg body weight. The body weight evolution was not influenced during the 14-day observation period. All animals showed red brown lips and a slightly harsh skin 20-30 minutes after administration; one animal showed diarrhea 3-7 hours after administration. After 24 hours the skin was very harsh and the animals showed a squatting attitude; 4 animals showed diarrhea and 3 had a dirtily brown skin. After 48 hours , the skin was still slightly harsh and after 72 hours all animals were without poisoning symptoms. Dissection at the end of testing showed only in 1 animal with a partial bulge of the stomach mucosa. All treated animals were free from poisoning symptoms after 72 hours.