[No public or meaningful name is available]

Endpoint summary

Description of key information

Oral (OECD 423), rat: LD50: > 2000 mg/kg bw (limit test)

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:

29 Nov - 19 Dec 2016

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)

Remarks:

National Institute of Environmental Research, Republic of Korea

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

(Crl:CD(SD)), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8 weeks
- Weight at study initiation: 180.3 - 203.7 g
- Fasting period: overnight, approximately 16 h prior to dosing up to 4 h post dosing
- Housing: individually 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: tap water filtered and irratiated by ultraviolet light, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 24.5
- Humidity (%): 45.7 - 66.8
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.37 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to low expected toxicity of the test substance, 2,000 mg/kg bw was selected as the starting dose (limit test) for this study based on the information supplied by the sponsor.

Doses:

step 1 and 2: 2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs such as tremor, convulsions, salivation, diarrhea, lethargy and vocalisation (type, severity, time of onset and recovery) 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). The body weight was recorded 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

Statistics:

Body weights and body weight gain: Calculation of group mean values and standard deviations.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths of animals at the dose of 2000 mg/kg bw throughout the study.

Clinical signs:

other: Mucous stool was observed in two animals of step 2 at 6 h after dosing and in all animals on Day 1 at 2000 mg/kg bw and disappeared on Day 2. This clinical sign was considered to be a test substance-related effect.

Gross pathology:

No visible findings were observed at gross pathology in any animal dosed with 2000 mg/kg bw.

Interpretation of results:

GHS criteria not met

Conclusions:

In this acute oral toxicity study in rats an LD50 value of > 2000 mg/kg bw was found.

Executive summary:

The purpose of this study was to assess the potential toxicity test item following a single oral dose administration to female Sprague-Dawley rats. Two dose groups of three females received:

Steps 1−2: A dose of 2,000 mg/kg bw was administered and no mortality was observed (Step 1). A second dose of 2,000 mg/kg bw was administered. Again, no mortality was observed (Step 2). The study was finished at that point.

There were no deaths of animals at 2,000 mg/kg bw. Mucous stool was observed in animals on the day of dosing and Day 1 at the dose of 2,000 mg/kg bw. This change disappeared on Day 2.

No test substance-related effects were observed in body weight data or necropsy findings in any of the animals dosed with 2,000 mg/kg bw.

Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was not classified according to the CLP regulation and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study, 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

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2017). In this study, no mortality was observed at 2000 mg/kg bw (steps 1 and 2) in female rats.

Mucous stool was observed in animals after dosing on Day 1 at 2000 mg/kg bw and disappeared on the next day.

Thus, an LD50 value > 2000 mg/kg bw for female rats was derived.

Justification for classification or non-classification

The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.