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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report of study following classical method for acute Limit Test, in accord with EPA test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA 40 CFR 163.81-1
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
439-070-6
EC Name:
-
Cas Number:
125005-87-0
Molecular formula:
Not applicable
IUPAC Name:
(2R,3R,4S,5S)-2,3,4,5-tetrahydroxyhexanal (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (2S,3S,4S,5R)-2,3,4,5-tetrahydroxy-6-oxohexanoic acid acetic acid calcium dihydride hydrate magnesium dihydride potassium hydride sodium hydride

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rats 200-215g weight at study start. Housed in single-sex groups, with free access to water and food (except 24 hours pre-dose) and at 70 +/-2 degrees F.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
Rats starved for 24 hours pre-dose.
Doses:
5000 mg/kg
No. of animals per sex per dose:
6 males, 6 females.
Control animals:
yes
Details on study design:
Rats weighed prior to dosing, then 7 and 14 days later. Observed 1, 2 and 4 hours post-dose, then daily up to 14 days after dosing. Gross pathology observations made at necropsy.
Statistics:
No applicable.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: NOEL
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No evidence of toxicity was seen.
Mortality:
None seen.
Clinical signs:
other: No effects of treatment.
Gross pathology:
No effects of treatment.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under EU criteria, no classification for acute toxicity applies.