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Endpoint summary

Description of key information

The acute oral toxicity of ERGP-IEM was evaluated in a study in rats. The results of the study were:

ERGP-IEM has a rat oral LD50 > 2,000 mg/kg when tested according to OECD 423.

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:

2020

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M, Lot# 6252020
- Purity, including information on contaminants, isomers, etc.: No data.


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, humidity and protected from light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: No data.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test article was formulated as a 20% (w/w) mixture in ethanol and vortexed until visibly homogeneous.
- Preliminary purification step (if any): No data.
- Final concentration of a dissolved solid, stock liquid or gel: 20%.
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): No data.


OTHER SPECIFICS
- Other relevant information needed for characterising the tested material, e.g. if radiolabelled, adjustment of pH, osmolality and precipitate in the culture medium to which the test chemical is added: No data.

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) : NA
- Source: Charles River, Raleigh NC
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 2 months.
- Weight at study initiation: 199 - 221 grams
- Fasting period before study: The rats will be fasted 16 to 20 hours prior to test article administration.
- Housing: Animals will be individually housed in suspended wire-bottom cages that conform to the size recommendations in the Guide for the Care and Use of Laboratory Animals
(National Research Council).
- Diet (e.g. ad libitum): Fresh, Certified Rodent LabDiet® No. 5002 (or similar) will be available ad libitum during acclimation and the study except for 16 to 20 hours prior to dosing.
- Water (e.g. ad libitum): Water will be available ad libitum.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 26 December, 2019 To: 16 January 2020

Route of administration:

oral: gavage

Vehicle:

ethanol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test article was formulated as a 20% (w/w) mixture in ethanol and vortexed until visibly homogeneous.
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required): Ethyl alcohol, pure (Ethanol), Lot/batch No.: SHBK9944
- Purity: Pure ethanol.

MAXIMUM DOSE VOLUME APPLIED: The test article was mixed with ethanol to make dosing by gavage possible. The dose was based on the dry weight of the test article. A single dose was administered orally by syringe and dosing needle at a dose level of 2000 ml/kg to six female rats.

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

Limit Test: 2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: Animals will be observed at 15 (±5) minutes, 1, 2 and 4 hours post-dosing and at least once daily thereafter for 14 days.
- Frequency of observations and weighing: Body weight will be recorded pre-test, weekly, and at death, or termination in the survivors.
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

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.

Clinical signs:

other: Abnormal physical signs including ataxia, piloerection, chromorhinorrhea, dyspnea, and diminished fecal output were observed among all six animals within 24 hours following dose administration. From 48 hours post-dosing to study termination, no abnormal p

Gross pathology:

Pale areas were observed on the liver of one animal.

Other findings:

None.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The oral LD50 of ERGP-IEM is greater than 2000 mg/kg of body weight in female rats and is considered to be in GHS Category 5.

Executive summary:

The objective of this study was to determine the potential for toxicity of ERGP-IEM when administered orally. The study was conducted according to GLP. The test method was conducted based on the OECD Guideline no. 423 (2001). Six healthy female Sprague Dawley rats were dosed orally with ERGP-IEM at 2000 mg/kg. The rats were observed at 15 (± 5) minutes, 1-, 2-, and 4-hours post-dosing and at least once daily for 14 days. All animals were observed twice daily for mortality on Day 1 to Day 14. Body weights were recorded pretest, weekly, and at termination.

All animals survived the study.Abnormal physical signs including ataxia, piloerection, chromorhinorrhea, dyspnea, and diminished fecal output were observed among all six animals within 24 hours following dose administration. From 48 hours post-dosing to study termination, no abnormal physical signs were observed. The gross necropsy revealed no observable abnormalities among five out of six animals. Pale areas were observed on the liver of one animal.

The oral LD50 of ERGP-IEM is greater than 2000 mg/kg of body weight in female rats and is considered to be in GHS Category 5.

Endpoint conclusion

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Justification for classification or non-classification

Based on the results of the study, ERGP-IEM meets the oral toxicity classification criteria for GHS Category 5.