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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no date
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
This information is not provided in the migrated NONS file provided by ECHA.

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female
Details on test animals and environmental conditions:
This information is not provided in the migrated NONS file provided by ECHA.

Administration / exposure

Route of administration:
other: This information is not provided in the migrated NONS file provided by ECHA.
Vehicle:
corn oil
Details on oral exposure:
This information is not provided in the migrated NONS file provided by ECHA.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males
5 femelles
Control animals:
other: This information is not provided in the migrated NONS file provided by ECHA.
Details on study design:
This information is not provided in the migrated NONS file provided by ECHA.
Statistics:
This information is not provided in the migrated NONS file provided by ECHA.

Results and discussion

Preliminary study:
This information is not provided in the migrated NONS file provided by ECHA.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male & femelle (5000 mg/kg bw); Number of animalss: 5 of each sex; Number of deaths : 0
Clinical signs:
Signs of toxicity related to the dose (5000 mg/kg bw) : soft stools in 2 females the day of treatment. This was not considered as remarkable.
Body weight:
This information is not provided in the migrated NONS file provided by ECHA.
Gross pathology:
Effects on organs : no remarkable findings.
Other findings:
This information is not provided in the migrated NONS file provided by ECHA.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] was not classified for acute toxicity via the oral route of exposure (LD50 > 5000 mg/kg bw).
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule.

The acute oral toxicity to rats has been determined according to OECD Guideline 401 and in compliance with GLP.

A limit test was performed and a single dose of 5000 mg/kg was received by rats, 5 males and 5 femelles.

No mortality occured and no remarkable clinical signs or effects on organs were observed.

The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] is not classified for acute toxicity via the oral route of exposure according to the criteria of DSD and CLP (LD50 > 5000 mg/kg bw).