Dodecanoic acid, ester with 1,2-propanediol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Nov 1998 - 25 Feb 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecanoic acid, ester with 1,2-propanediol

EC Number:

253-462-2

EC Name:

Dodecanoic acid, ester with 1,2-propanediol

Cas Number:

37321-62-3

Molecular formula:

C15H30O3 C27H52O4

IUPAC Name:

Dodecanoic acid, ester with 1,2-propanediol

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
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: 5-7 weeks
- Weight at study initiation: females: 131-148 g, males 172-188 g
- Fasting period before study: yes, overnight.
- Housing: groups of up to 5 of the same sex in polycarbonate cages type M1 on dust-free sawdust bedding
- Diet (e.g. ad libitum): pelleted complete diet, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 26.1 to 89.7
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 08 Dec 1998 - 22 Dec 1998

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.18 mL/kg

Doses:

2003 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: mortality and abnormal clinical signs were examined 15 min, 1 h, 2 h, and 4 h after administration and thereafter once daily.
- Frequency of weighing: on the day before treatment, immediately before treatment (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes, on day 15.

Statistics:

None.

Results and discussion

Preliminary study:

Doses of 505, 1002 and 2003 mg/kg administered to one male and one female rat per dosage resulted in no mortalities during an observation period of 7 days after administration.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

rat

Effect level:

> 2 003 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed.

Clinical signs:

other: other: No abnormal clinical signs in any of the treated animals during the entire observation period.

Body weight:

lower than 10% body weight loss

Gross pathology:

No macroscopic findings at necropsy.

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.