Resinoid of Boswellia serrata (Burseraceae) obtained from exudate by hexane extraction

Endpoint summary

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:

2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Specific details on test material used for the study:

LI13019F1 (Serratrin) is a unique composition of acidic and non-acidic components derived from an aqueous ethanol extract of B serrata gum resin. The gum resin was extracted with aqueous ethanol, and the concentrated extract was subjected to phase separation to obtain Boswellia nonacidic resin extract and the acidic extract containing BAs. Two parts of the BAs containing resin extract and one part of the nonacidic resin extract were combined, milled, and sieved using a unique process to obtain LI13019F1. To maintain the quality and batchto-batch consistency, LI13019F1 was standardized to contain at least 30% of total BAs with not less than 5% KBAs.

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

9-week-old female (n = 5) Wistar rats.
Wistar rats were purchased from Vivo BioTech Limited (Hyderabad, India). The experimental animals were specific pathogen-free. The animals were acclimatized to the laboratory conditions for 7 days and maintained in a controlled environment (21C + 2C, 40%-70% relative humidity, and 12 hour/12 hour light/dark cycle). During the study
period, the animals were allowed free access to a standard diet and bottled mineral water. The Institutional Animal Ethics Committee approved the experimental protocols. The animal care operating procedure followed the guidelines of the Committee for the Purpose of Control and Supervision of Experiments on Animals, India

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

CMC-Na (0.5% wt/vol)

Details on oral exposure:

a limit test was performed utilizing 9-week-old female (n = 5) Wistar rats. LI13019F1 suspended in CMC-Na (0.5% wt/vol) was administered by gavage at a dose of 2,000 mg/kg body weight (BW).

Doses:

2000mg/kg

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

Before the test item administration, the animals were observed for clinical signs. The animals were monitored for morbidity/mortality or clinical signs at 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours after the test item administration. Thereafter, all animals were observed once daily for 14 consecutive days. Body weights were measured once a week during the observation period. The vital organs and tissues were subjected to gross pathological examinations following CO2 euthanasia on day 15.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality observed

Clinical signs:

The animals did not show any clinical signs of toxicity during the 15-day follow-up period

Body weight:

The animals did not show abnormal changes in their body weights during the observation period

Gross pathology:

A gross pathological examination also did not reveal any abnormalities

Interpretation of results:

GHS criteria not met

Executive summary:

In a publication, Laila Nutraceuticals R&D Center made a toxicological assessment of a standardized Boswellia serrata Gum Resin Extract.

The acute oral toxicity study was performed according to OECD 425 guideline, followinf Good Laboratory Practices.

In this study, the extract show no acute oral toxicity (LD50>2000mg/kg bw/day).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw