2-methoxyethyl acetoacetate

Endpoint summary

Description of key information

A study was carried out according to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. 4 groups of 4 rats (2 male, 2 female) for Dose-Range-Finding and 1 group of 10 rats (5 male, 5 female) for the main study were treated by gavage with doses of 50, 250, 1250 and 5000 mg/kg in the pretest and with 5000 mg/kg in the main study. The LD50 was determined to be ca. 5000 mg/kg for both sexes.

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:

November-December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-study (non-GLP)

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldbrough, Nr. Hull
- Weight at study initiation: 125-146 g
- Housing: five animals per cage by sex and dose group
- Diet (e.g. ad libitum): Rat and Mouse Food No. 1 Modified, BP Nutrition (UK) Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25°C
- Humidity (%): recorded daily
- Photoperiod (hrs dark / hrs light): 12 hours artificial light

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test article preparations were administered once only by oral gavage using a metal stomach tube (14 gauge x 8 cm,
Stand Medicals Ltd., Manchester) attached to a 2 ml disposable plastic syringe. Individual doses were based on the fasted body weight of the animals at the time of treatment.

Doses:

PRELIMINARY STUDY:
- 50, 250, 1250 and 5000 mg/kg

MAIN STUDY:
- 5000 mg/kg

No. of animals per sex per dose:

PRELIMINARY STUDY:
- 2 males & 2 females

MAIN STUDY:
- 5 males & 5 females

Control animals:

no

Preliminary study:

No deaths were noted at the end of the 48-hour observation period.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Four animals (1 male, 3 females) died during the study. The females died 24-48 hours after treatment and the male on day 4.

Clinical signs:

other: All treated animals were lethargic 15 minutes after dosing. The majority continued to be lethargic throughout the day of dosing. Other toxic signs noted 2-4 hours after treatment were hunched posture and piloerection. Signs of intoxication noted in surviv

Gross pathology:

No necropsies were performed.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity LD50 on WistarAlbino rats was determined to be ca. 5000 mg/kg for males and females.

Executive summary:

A study was carried out according to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. 4 groups of 4 rats (2 male, 2 female) for Dose-Range-Finding and 1 group of 10 rats (5 male, 5 female) for the main study were treated by gavage with doses of 50, 250, 1250 and 5000 mg/kg in the pretest and with 5000 mg/kg in the main study. No mortality was observed in the pretest. Four animals (1 male, 3 females) died during the main study. All treated animals were lethargic 15 minutes after dosing. The majority continued to be lethargic throughout the day of dosing. Other toxic signs noted were hunched posture, piloerection, prostration, emaciation, perinasal haemorrhage, deep, rapid breathing, and difficult or laboured breathing. All surviving animals appeared normal 7 days after treatment. Animals showed normal body weight gains at the end of the 14 day observation period. Necropsy was not performed. The LD50 was determined to be ca. 5000 mg/kg for both sexes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Justification for selection of acute toxicity – oral endpoint
Klimisch 2 study; test design according to OECD 401 (non-GLP)

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).