[(3-Oxo-butyryl)-phenyl-amino]-acetic acid ethyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

n-phenyl n-acetoacetyl glycine ethyl ester

IUPAC Name:

n-phenyl n-acetoacetyl glycine ethyl ester

Test material form:

liquid

Specific details on test material used for the study:

TEST MATERIAL NAME (as stated in study report): Intermediate 37

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Valtris Specialty Chemicals Ltd. / Batch/Lot No. W042272
- Expiration date of the lot/batch: November 21, 2019
- Purity: 84.5%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. Containers kept tightly closed in a dry, cool and well ventilated place.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 160 - 181 g
- Fasting period before study: overnight prior to dosing
- Housing: Polypropylene rat cages covered with stainless steel grid tops. Two rats per cage.
- Diet (e.g. ad libitum): ad libitum with exception of fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 to 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 °C
- Humidity (%): 49 to 66%
- Air changes (per hr): Minimum 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

300, 2000 mg/kg

No. of animals per sex per dose:

300 mg/kg - one animals
2000 mg/kg - five animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5-6 h post-administration on the day of dosing. Subsequently, the rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

Not needed.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

No clinical signs were observed

Body weight:

Normal gain in body weight was observed

Gross pathology:

No effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified by CLP Criteria

Conclusions:

Under guideline (OECD 420) test conditions, the acute oral LD50 of Intermediate F37 was greater than 2,000 mg/kg in female Wistar rats.