Fir, Abies balsamea, ext.

Endpoint summary

Description of key information

Acute oral toxicity: LD50 >2000 mg/kg bw (according to OECD TG 423, EU TM B.1tris)

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:

31 Oct 2017 - 15 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:

17th December 2001

Deviations:

yes

Remarks:

No chemical analysis of the dose formulation was performed as part of this study. The absence of dose formulation analysis data was considered not to prejudice the overall GLP status of the study and the scientific reliability of the study conclusions.

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris, EPA Health Effects Test Guidelines (OPPTS 870.1100), United States, EPA 712-C-98-190 (1998)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Botanical source and Lot# 67919
- Expiration date of the lot/batch: 13 septembre 2018
- Purity test date: UVCB, considered 100% pure

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (15-25 °C, ≤ 70 RH%), protected from light, avoid contact with iron.

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI Wistar rats

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks old
- Weight at study initiation: 232-258g
- Fasting period before study: night before treatment
- Housing: 3 animals / cage.
- Diet (e.g. ad libitum): ssniff® SM R/M (ad libitum except for night before treatment)
- Water (e.g. ad libitum): municipal tap water in 500mL bottles (ad libitum)
- Acclimation period: at least 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 25.5 deg C
- Humidity (%): 32 - 91%
- Air changes (per hr): 15-20 air exchanges/hr
- Photoperiod (hrs dark / hrs light): 12 hours (6am to 6pm)

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200mg/mL
- Amount of vehicle (if gavage): 10mL/kg bw
- Lot/batch no. (if required): lot A0386839 from Acros Organics (exp 31 july 2019)

MAXIMUM DOSE VOLUME APPLIED: limit dose of 2000mg/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as required by guideline OECD 423

Doses:

2000mg/kg

No. of animals per sex per dose:

3 animals/dose (if no or one animal dies, same dose is repeated 3 animals)
Only females (nulliparous and non-pregnant animals) are part of the study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30min, 1, 2, 3, 4, 6 hrs, then once a day for 14 days
- Necropsy of survivors performed: yes
- Histopathological examination was not performed
- Other examinations performed: skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention will be directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Body weights at different periods will be recorded

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality at a dose level of 2000 mg/kg bw.

Clinical signs:

other: At dose level of 2000 mg/kg bw, the following symptoms were observed from Day 0 up to Day 1: hunched back (6 out of 6 animals), slightly decreased activity (3 out of 6 animals) and slight incoordination (1 out of 6 animals). From Day 2 all animals were sy

Gross pathology:

Necropsy:
There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) was found to be above 2000 mg/kg bw in female Crl:WI rats.
According to the GHS criteria, Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) can be ranked as "Category 5" for acute oral exposure.

Executive summary:

The single-doseoral toxicity of Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008of30 May2008, B.1.tris) in female Crl:WI Wistar rats.

Two groups of 3 female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).

A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment.The test item was formulated in corn oil at a concentration of 200 mg/mL at a dose volume of 10 mL/kg bw. Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No other mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and CommissionRegulation(EC) No440/2008 of 30 May 2008, B.1.tris.

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 7 and 14 (before necropsy). All animals were subjected to a necropsy and a macroscopic examination.

The results of the study were summarized as follows:

Mortality

Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) did not cause any mortality at a dose level of 2000 mg/kg bw.

Clinical Observations

At dose level of 2000 mg/kg bw, the following symptoms were observed from Day 0 up to Day 1: hunched back (6 out of 6 animals), slightly decreased activity (3 out of 6 animals) and slight incoordination (1 out of 6 animals). From Day 2 all animals were symptom-free.

Body Weight and Body Weight Gain

There were no effects on body weights or body weight gains that could be attributed to treatment with of Fir Needle Oil Canadian (Fir, Abies Balsamea, ext).

Necropsy

There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw

Under the conditions of this study, the acute oral LD₅₀value of the test item Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) was found to be above 2000 mg/kg bw in female Crl:WI rats. According to the GHS criteria, Fir Needle Oil Canadian (Fir, Abies Balsamea, ext) can be ranked as "Category 5" for acute oral exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available