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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Remarks:
Maximum non-lethal dose
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Acute toxicity studies:

Acute oral toxicity investigations in rats
(Charles River CD strain for the substance, AHH-R
or AP1-R strains) were undertaken by determining the
range in which the maximum non-lethal dose (MNLD)
occurred.

A dose-range finding study with two rats per sex
per group examined doses of 25, 200, 1000, 2000
or 5000 mg/kg bodyweight: the highest dose was
only administered if no significant changes were
seen at lower doses after two hours. Mortalities
and clinical signs were recorded for 14 days. A
confirmatory study, with a 14 day observation
period, using five rats per sex examined the MNLD
determined by the range-finder.
GLP compliance:
not specified
Test type:
other:

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
EC Number:
607-813-5
Cas Number:
25830-77-7
Molecular formula:
C13 H9 N O5
IUPAC Name:
2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
Test material form:
solid

Test animals

Species:
rat
Strain:
other:
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
25, 200, 1000, 2000
or 5000 mg/kg bodyweight: the highest dose was
only administered if no significant changes were
seen at lower doses after two hours
No. of animals per sex per dose:
2
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 - < 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the available information the substance is not classified for acute oral toxicity.
Executive summary:

Acute toxicity studies: Acute oral toxicity investigations in rats (Charles River CD strain for the substance, AHH-R or AP1-R strains) were undertaken by determining the range in which the maximum non-lethal dose (MNLD) occurred. A dose-range finding study with two rats per sex per group examined doses of 25, 200, 1000, 2000 or 5000 mg/kg bodyweight: the highest dose was only administered if no significant changes were seen at lower doses after two hours. Mortalities and clinical signs were recorded for 14 days. A confirmatory study, with a 14 day observation period, using five rats per sex examined the MNLD determined by the range-finder.

Maximum non-lethal dose is between 2000 and 5000 mg/kg.

Based on the available information the substance is not classified for acute oral toxicity.