Fatty acids, C16-18 (even numbered), esters with 1,2-propanediol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no data on individual body weights available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

limited data available (no data on individual body weights available)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1323-39-3/29013-28-3

IUPAC Name:

1323-39-3/29013-28-3

Test animals

Species:

rat

Strain:

other: SPF Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Weight at study initiation: 120 g
- Fasting period before study: animals were fasted for approx. 16 h prior to administration
- Housing: randomized into 2 groups in macrolon plastic cages bedded with wood chips (Ssniff/bedding, Intermast, Soest, Germany)
- Diet: pellets (Ssniff/Intermast, Soest, Germany)
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): the amount of vehicle administered was based on body weight (4.81, 4.83, 9.75 or 9.58 mL for 2500 or 5000 mg/kg bw test substance in males and females, respectively).

MAXIMUM DOSE VOLUME APPLIED: 9.75 mL

Doses:

2500 and 5000 mg/kg bw
(10 000 and 20 000 mg/kg bw test item solution containing 25% test substance)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed prior to substance administration and at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Group mean values of body weights were calculated.

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 was observed until the end of the treatment period.

Clinical signs:

other: Lightly decreased activity and slight disturbances of coordination were observed about 20 min after substance administration and held for 2 h. Afterwards, all animals appeared normal.

Body weight:

other body weight observations

Remarks:

Animals gained weight during the observation period (average body weight gain: 23.3 and 23.7 g for the low- and high-dose group, respectively).

Gross pathology:

No gross pathological findings were identified at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.