Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

Acute Toxicity: oral

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

Test material information

Constituent 1

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