Propanoic acid, 2-hydroxy-, C12-13-branched alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 24 Mar 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study. The rats were not fasted before dosing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

rats were not fasted before dosing

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters

IUPAC Name:

Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters

Details on test material:

- Name of test material (as cited in study report): (C12-C13) Alkyl lactate
- Analytical purity: 100% (UVCB)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morini, S. Polo d'Enza, Italy
- Weight at study initiation: 166 ± 4.18 g (males, mean ± SD); 150 ± 7.07 g (females, mean ± SD)
- Housing: the animals were housed in groups of 5 by sex in transparent polycarbonate cages (42.5 cm x 26.6 cm x 18.0 cm)
- Diet: standard pellet complete diet (Morini, S. Polo d'Enza, Italy), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 25 (maintained at a pressure higher than the outside atmosphere)
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Mar 1992 To: 24 Mar 1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle: 20 mL/kg bw
- Justification for choice of vehicle: sesame seed oil is documented to be non-toxic

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality daily (Monday - Friday); clinical signs were monitored daily (Monday - Friday); the body weight was recorded on Day 0 (prior to administration), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (behaviour, external examination, mucous membranes, somatomotor activity, sensory functions)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs were observed up to the end of the 14-day observation period.

Gross pathology:

The necropsy and histopathological examination did not reveal substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified