Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is non-GLP, but well described except for ommissions in experimental conditions like temperature and humidity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Twenty-five young adult rats were distributed into five dosage groups and exposed to various dosages of test material administered by intragastric intubation.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

EC Number:

300-338-1

EC Name:

Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

Cas Number:

93925-36-1

Molecular formula:

C3O2-C12/13/14/15

IUPAC Name:

Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

Constituent 2

Reference substance name:

Ceraphyl 41

IUPAC Name:

Ceraphyl 41

Test material form:

other: liquid

Details on test material:

Batch 1363

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Type: young adult albino rats
Housing: in mesh bottom cages and fasted 24 h prior to dosing
TEST ANIMALS
- Source: Wistar
- Age at study initiation: young adult
- Weight at study initiation: 20 - 300 g
- Fasting period before study: 24 h
- Housing: mesh bottom cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No further details.

Doses:

2.5, 5.0, 10, 20, 40 ml/kg bw.

No. of animals per sex per dose:

Males: 3
Females: 2

Control animals:

no

Details on study design:

The rats received food and water ad libitum after dosage and were observed daily for 14 days following administration.

Statistics:

The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261, 1944)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

21 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Standard deviation: 9.2 mL/kg bw

Mortality:

Dosage Animals Number of deaths daily day 14
mL/kg dosed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 % Mortality
2.5 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
10.0 5 0 0 0 1 0 0 0 0 0 0 0 0 0 0 20
20.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
40.0 5 0 0 0 1 0 1 1 0 1 0 0 0 0 0 80

Clinical signs:

No details.

Body weight:

Rats were weighing between 200-300 grams, no effects recorded on body weights.

Gross pathology:

No details.

Other findings:

No details.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Ceraphyl 41 for rats is more than 10 times higher than the maximum limit for classification of 2000 mg/kg bw .

Executive summary:

The acute oral LD50 of CERAPHYL® 41 was 21 ml/kg bodyweight in rats. Twenty five Wistar albino rats (3 male, 2 female/group) were dosed orally with CERAPHYL® 41 at 2.5, 5, 10, 20 and 40 ml/kg bodyweight. Animals were observed daily for mortality for 14 days. Four animals in the 40 ml/kg group died. One animal in the 10 ml/kg group died.