[No public or meaningful name is available]

Endpoint summary

Description of key information

In an acute oral study in rats conducted to OECD TG 423 (Acute Toxic Class) (Safepharm Laboratories Ltd., 2001) and in compliance with GLP there were no deaths at a dose of 2000 mg/kg bw of the test substance. The authors concluded the LD50 to be >2500 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:

10/10/2001 to 08/11/2001

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:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: Approximately 8 weeks.
- Weight at study initiation: At least 200 g.
- Fasting period before study: Yes, overnight fast immediately before dosing.
- Housing: In groups of three single sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Ad libitum, except during pre-dosing fast and for 3-4 hours after dosing.
- Water (e.g. ad libitum): Ad libitum, except during pre-dosing fast and for 3-4 hours after dosing.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): At least 15 per hour.
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.16 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: None given, limit dose

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Three

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths and overt signs of toxicity at 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes, all animals were subjected to gross pathological examination. This consisted of an external examination and examination of major organs. The appearance of macroscopic abnormalities was recorded.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Statistics:

Using the mortality data obtained, an estimate of the acute median lethal dose (LD50) of the test material was made.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity.

Body weight:

All animals showed expected gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on an acute oral study in rats conducted to OECD TG 423 (Acute Toxic Class; reliability score 1) and in compliance with GLP there were no deaths at a dose of 2000 mg/kg bw. The authors concluded the LD50 to be >2500 mg/kg bw. There were no adverse clinical signs, effects on body weight gain or abnormal findings during necropsy examinations.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 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

Additional information

In the oral acute toxicity study (Safepharm Laboratories Ltd., 2001) in which a single limit dose of 2000 mg/kg bw of the test substance was tested in Sprague-Dawley rats, there were no deaths, adverse clinical signs, effects on body weight gain or abnormal findings during necropsy examinations during a 14-day observation period following exposure. The LD₅₀ was >2500 mg/kg bw

Justification for classification or non-classification

Based on the available acute oral toxicity study in rats, the substance is not classified for acute toxicity under Regulation (EC) No. 1272/2008.