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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (only 2 animals/step exposed simultaneously).

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
(2 males and 2 females used, simultaneous exposure)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids
EC Number:
931-434-7
Cas Number:
1338-39-2
Molecular formula:
C18H34O6
IUPAC Name:
Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids
Constituent 2
Reference substance name:
931-434-7
EC Number:
931-434-7
IUPAC Name:
931-434-7

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight: males 296 g, females 219 g

Administration / exposure

Route of administration:
oral: gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 females, 2 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths or clinical symptoms were observed in all animals treated.
Clinical signs:
other: No deaths or clinical symptoms were observed in all animals treated.
Gross pathology:
No pathological changes were observed at gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified