Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
17 Oct - 16 Nov 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
08 Feb 2002
Deviations:
yes
Remarks:
acclimatisation period less than 5 days
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan, tridocosanoate
EC Number:
301-037-8
EC Name:
Sorbitan, tridocosanoate
Cas Number:
93980-59-7
Molecular formula:
C72H138O8
IUPAC Name:
Sorbitan tridocosanoate

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Age at study initiation: 8 - 9 weeks old
- Weight at study initiation: 186.3 - 222.7 g
- Fasting period before study: animals were fasted over night, approx. 16 h
- Housing: individual, in stainless wire mesh cage, 260W×350D×210H (mm)
- Diet: Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), ad libitum
- Water: Public tap water, filtered and irradiated by ultraviolet light, ad libitum ; analysis was performed
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3 - 27.2
- Humidity (%): 40.2 - 64.9
- Air changes (per hr): 10 - 15 clean, fresh, filtered
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
(0.5% Methylcellulose 1,500cP solution)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Lot/batch no.: Methylcellulose 1,500cP (Lot no.: SLBL2578V, SIGMA-ALDRICH, Co., U.S.A.) dissolved in water for injection (Lot no.: DBA7004, JW Pharmaceutical Co., Ltd., Republic of Korea)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg because there was no available toxicity information on the test substance.
Doses:
300 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Remarks:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 min after dosing and at 1, 2, 4 and 6 h after dosing on Day 0 and once daily thereafter for 14 days (Day 1 - Day 14)
- Frequency of weighing: prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy (Day 14)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, complete gross postmortem examinations
Statistics:
Statistical analysis was not performed. Mean scores and values were presented.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No abnormalities of clinical signs were observed during the study period.
Gross pathology:
No grossly visible findings were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008