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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scinetifically valid study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In this study predating the implementation of OECD guidelines seven dose levels were tested. One rat per dose was used, the observation time was 10-12 days. Clinical signs were examined, macroscopical examination at necropsy was performed.
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dimethyl 5-sulphonatoisophthalate
EC Number:
223-578-8
EC Name:
Sodium dimethyl 5-sulphonatoisophthalate
Cas Number:
3965-55-7
Molecular formula:
C10H10O7S.Na
IUPAC Name:
sodium 3,5-bis(methoxycarbonyl)benzenesulfonate
Test material form:
not specified
Details on test material:
substance name used in report: Sodium Sulfo Dimethylisophthalate

Test animals

Species:
rat
Strain:
other: ChR-CD
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 30% susp. in 1% aqueous gum guar
Doses:
1000, 1500, 2250, 3400, 5000, 7500 and 11000 mg/kg bw.
Doses from 1000 to 5000 mg/kg bw were given as a single dose, whereas 7500 and 11000 mg/kg bw were given as 2 doses within 1 hr.
No. of animals per sex per dose:
1 animal per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10-12 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD0
Effect level:
11 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: Diarrhea, white precipitate in urine and feces, discomfort, weight loss in some cases. Minimal effects at 3400 mg/kg bw and less.
Gross pathology:
None attributable to treatment found 10-12 days after exposure.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the present study the approximate lethal dose (LDLo) was > 11000 mg/kg.
Executive summary:

In an acute oral toxicity study (Haskell Laboratory for Toxicology and Industrial Medicine, 1959, non-GLP) rats (1/dose) were treated orally with Sodium Sulfo Dimethylisophtalate in concentrations of 7500, 5000, 3400, 2250, 1500 and 1000 mg/kg by a single dose. Furthermore, 11000 and 7500 mg/kg were given in 2 doses within one hour. Diarrhea, white precipitate in urine and feces, discomfort, wt. loss in some cases were observed. Effects were minimal at 3400 mg/kg and less. No mortility occurred leading to an approximate lethal dose (LDLo) of > 11000 mg/kg.