Dodecyl 5-oxo-L-prolinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl 5-oxo-L-prolinate

EC Number:

245-224-1

EC Name:

Dodecyl 5-oxo-L-prolinate

Cas Number:

22794-26-9

Molecular formula:

C17H31NO3

IUPAC Name:

dodecyl 5-oxo-L-prolinate

Specific details on test material used for the study:

White powder provided by UCIB.
Insoluble in water.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo
- Age at study initiation: 6 weeks
- Weight at study initiation: 182 +/- 3 g for males and 142 +/- 3 g for females
- Fasting period before study: 18 hours before treatment water
- Housing: 4 or 7 animals/ sex during acclimatation and 5 animals/sex during study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
- The single administration was followed by a 14-day observation period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50+/- 20 %
- Air changes (per hr): non recycle but filtered with absolute filters
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: see below

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5% aqueous solution of methylcellulose
- methylcellulose, batch 90064
- water for injections, batch 1298
formed a suspension with the test item

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
clinical signs: frequent observations within hours of treatment
mortality: at least twice a day
- Necropsy of survivors performed: yes
- Other examinations performed:
body weight: before treatment and at Day 5,8 and 15
organ weights: no
histopathology: no macroscopic findings was observed consequently, no histological exam was performed

Statistics:

Not performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

No clinical sign was observed

Body weight:

No body weight modification was observed

Gross pathology:

No abnormality was observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under experimental conditions, the LD50 of the test substance, LAURYL PIDOLATE, when administered by oral route in rats was higher than 2000 mg/ kg bw. No signs of toxicity were observed at this dose.

Based on OECD 401 GLP compliant study, results are considered scientifically valid to be used to support a non classification.