Sorbitan, tridocosanoate

Endpoint summary

Description of key information

Acute oral toxicity (OECD 423, rat, f): LD50 > 2000 mg/kg bw

Acute inhalation toxicity: No study required as the inhalation route of exposure is considered less relevant than the dermal route.

 

Acute dermal toxicity: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required. Sorbitan tridocosanoate (CAS 9380-59-7) does not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin sensitisation).

 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

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.

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

Sorbitan tridocosanoate was tested for acute oral toxicity according to OECD guideline 423 (Acute Toxic Class Method) and in compliance with GLP (Riken Vitamin, 2017). The test item was dissolved in 0.5% aqueous methylcellulose and applied to groups of 3 female Sprague-Dawley rats at dose levels of 2000 and 300 mg/kg bw. Following administration, the animals were observed for a time period of 14 days to assess general health, body weight gain and mortality. Thereafter, all animals underwent gross macroscopical examination.

No mortality was observed during the study period and there were no clinical signs of toxicity noted for any animal. All animals gained body weight as expected. At scheduled necropsy, no abnormal findings were observed. Under the conditions of the test, the acute oral lethal dose (LD50) was > 2000 mg/kg bw for female rats.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.

No information on acute toxicity via the inhalation and dermal routes of exposure are available for sorbitan tridocosanoate because the inhalation route is considered less relevant than the dermal route and the substance does not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin sensitisation).