Cyperus scariosus, ext.

Endpoint summary

Description of key information

LD50 (oral) > 2000 mg/kg bw

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:

6th February 2018-22nd March 2018

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)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

Batch Manufactured and supplied by
Jagat Aroma Oils Distillery,
Kannauj-209725,
Uttar Pradesh, India

Test Item : CYPRIOL (Cyperus Scariosus ext. Oil)

CAS No. : 91771-62-9 / 68916-60-9

Chemical Name (IUPAC)
Not applicable

Physical Appearance : Amber colored or Light Brown Liquid

Purity as per Certificate of Analysis: 100% Natural

Batch No. : Lot # 11/CYP/2016

Manufactured Date : November 2016

Retest Date : October 2018

Recommended Storage Condition: Ambient (+15 to +25°C)

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-Vivo Biosciences, Kodigehalli Village, Magadi Road, Bangalore, Code-29, Karnataka State

- Females (if applicable) nulliparous and non-pregnant: yes

- Age at study initiation: 9 to 11 weeks

- Weight at study initiation: 189.5-197.8g

- Fasting period before study: 16-18 hours

- Housing: Rats were housed individually in standard polysulfone cages
(Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage once a week.

Bedding: steam sterilized corn cob was used and changed once a week along with the cage.

- Diet (e.g. ad libitum): yes. Hypro Rat & Mice pellet feed, manufactured by Krishna Valley Agro Tech LLP, MIDC Kupwad block, Sangli, Maharashtra, was provided to animals.

- Water (e.g. ad libitum): yes. Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, was provided to animals in polycarbonate bottles with stainless steel sipper tubes.

- Acclimation period: After physical examination for good health and suitability for experiment, the animals were acclimatized for six, eight, ten and twelve days before treatment G1-FTS, G1-STS, G2-FTS and G2-STS respectively. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 64 to 67 %
- Air changes (per hr): 13.2 to 14.0 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.

IN-LIFE DATES: From: To:

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The undiluted test item as supplied by the sponsor was administered as a single oral gavage to the fasted (16 to 18 hours) access to water was not interrupted. Each animal was administered the test item orally by gavage using disposable plastic syringe attached with metal feeding cannula. Food was offered about 3 to 4 hours after dosing. Water was not withheld

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: There was no acute oral toxicological information is available for the test item Cyperus Scariosus. Hence, the study was initiated with the starting dose of 300 mg/kg body weight. Hence the test was started as per Annex 2c of the OECD 423 test guideline. The starting dose was 300 mg/kg body weight (G1 FTS).

Doses:

300 & 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Group Dose
(mg/kg) No. of
Rats Sex Rat numbers
From To
G1 (FTS) 300 3 Female Rm8031 Rm8033
G1 (STS) 300 3 Female Rm8034 Rm8036
G2 (FTS) 2000 3 Female Rm8037 Rm8039
G2 (STS) 2000 3 Female Rm8040 Rm8042

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

G1 - [300 mg/kg body weight – (FTS and STS)]: There were no pre-terminal deaths.
G2 - [2000 mg/kg body weight - (FTS and STS)]: There were no pre-terminal deaths.

Clinical signs:

other: G1 - [300 mg/kg body weight – (FTS and STS)]: There were no clinical signs. G2 - [2000 mg/kg body weight - (FTS and STS)]: There were no clinical signs.

Gross pathology:

No abnormalities were detected at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the present study, the test item, CYPRIOL (Cyperus Scariosus ext. Oil) has oral LD50 in the range of 2000 to 5000 mg/kg. The test item does not meet the criteria for classification per Regulation (EC) No 1272/2008.

Executive summary:

The acute oral toxicity study with CYPRIOL (Cyperus Scariosus ext. Oil) in Wistar rats was conducted to assess the toxicological profile of the test item.  The undiluted test item was administered as a single oral gavage to overnight fasted (16 to 17 hours) three female rats (G1-FTS) at a dose volume of 0.31 mL/kg body weight to attain the dose of 300 mg/kg body weight (G1-FTS). There were no clinical signs and pre-terminal deaths.

Based on the scheme - Annex 2c of the guideline OECD 423, three additional female rats were tested at the same dose of 300 mg/kg body weight (G1-STS). There were no clinical signs and pre-terminal deaths. Based on the scheme - Annex 2c of the guideline OECD 423, three female rats were tested at the next higher dose of 2000 mg/kg body weight and at the dose volume of 2.06 mL/kg body weight (G2-FTS). There were no clinical signs and pre-terminal deaths. Based on the scheme - Annex 2c of the guideline OECD 423, additional three female rats were tested at the same dose of 2000 mg/kg body weight (G2-STS). There were no clinical signs and pre-terminal deaths. Based on the scheme - Annex 2c of the guideline OECD 423, the dose was stopped.

The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the survived rats at terminal sacrifice. There were no clinical signs and mortality during the experiment period. All rats gained weight during experimental period. The rats were subjected to necropsy at termination and there were no abnormalities detected at necropsy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral exposure

There is one good quality guideline compliant acute toxicity study via oral route (OECD 423 - Acute Toxic Class Method) conducted for the substance (Kumar, U. 2018). The purpose of the study was to evaluate the potential toxic effect of the test item Cypriol after single oral administration to rats. A dose of 300 mg/kg body weight was used as starting dose. There were no clinical signs and pre-terminal deaths. Based on the scheme - Annex 2c of the guideline OECD 423, rats were tested at the next higher dose of 2000 mg/kg body weight. There were no clinical signs and pre-terminal deaths.

The post exposure period was 14 days. All animals were subjected to gross necropsy- no abnormalities were notes. All animals showed expected gains in bodyweight. The acute median lethal dose (LD50) of the test item in female Wistar rat was estimated to be greater than 2000 mg/kg bodyweight.

As a conclusion, the results of the key study did not indicate this substance to be classified for acute toxicity via oral route.

Justification for classification or non-classification

The available data for Cypriol indicate no potential for acute toxicity via oral route. Based on the oral LD50 value the substance no classification is warranted for acute toxicity according to CLP Regulation

1272/2008.