Decanoic acid, monoester with glycerol

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:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

National guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics" by the Staff of the Division of Pharmacology", FDA, 1959

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2,3-dihydroxypropyl laurate

EC Number:

205-526-6

EC Name:

2,3-dihydroxypropyl laurate

Cas Number:

142-18-7

Molecular formula:

C15H30O4

IUPAC Name:

2,3-dihydroxypropyl laurate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zucht Winkelmann, Paderborn, Germany
- Weight at study initiation: 120-145 g (males), 115-145 g (females)
- Fasting period before study: 16 h
- Housing: single caging
- Diet: standard laboratory diet (Ssniff/Intermast), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 20 and 40 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw

DOSAGE PREPARATION: The test substance was diluted in olive oil to a final concentration of 50%.

- Rationale for the selection of the starting dose: Based on a range-finding study (not further described), dose levels of 10 and 20 g/kg bw were selected for the determination of the LD50 value.

Doses:

10,000 and 20,000 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: 7 days
- Frequency of observations and weighing: animals were observed for clinical signs at 20 min, 1, 3, 24 and 48 h and 7 days post administration. Individual body weights were determined at study initiation (Day 0) and at the end of the observation period (Day 7).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

10,000 mg/kg bw: 0/5 males and 0/5 females died.
20,000 mg/kg bw: 1/5 males and 1/5 females were found dead at 48 h post-dose.

Clinical signs:

other: At both 10,000 and 20,000 mg/kg bw, slight staggering, ataxia and piloerection were observed 1 and 3 h post-dose (number of animals not specified). Effects were reversible within 24 h.

Gross pathology:

Gross necropsy of dead and sacrificed animals revealed no changes of the examined organs (brain, lung, heart, stomach, intestines, liver, spleen, kidneys, serous membrane/vessels, lymph nodes and gonads).

Any other information on results incl. tables

Table 1. Table for acute oral toxicity
Dose [mg/kg bw]	Mortalities [No. of animals/No. in group]	Time of death (post-administration)	Mortality [%]	Clinical signs / Duration
Males
10,000	0/5	-	0	Staggering, ataxia, piloerection / 1-3 h post-dose
20,000	1/5	48 h	20	Staggering, ataxia, piloerection / 1-3 h post-dose
Females
10,000	0/5	-	0	Staggering, ataxia, piloerection / 1-3 h post-dose
20,000	1/5	48 h	20	Staggering, ataxia, piloerection / 1-3 h post-dose

 

Table 2. Body weight and body weight gain
Animal number	Body weight on Day 0 [g]	Body weight on Day 7 [g]	Body weight gain [%]
Males (10,000 mg/kg bw)
1	130	155	19
2	135	160	19
3	120	135	13
4	140	150	7
5	145	165	14
Mean	134	153	14
Feales (10,000 mg/kg bw)
1	120	145	21
2	115	130	13
3	130	155	19
4	120	145	21
5	140	160	14
Mean	125	147	18
Males (20,000 mg/kg bw)
1	140	- (dead)	-
2	145	155	7
3	135	120	-11
4	140	145	4
5	145	155	7
Mean*	141.25	143.75	2
Females (20,000 mg/kg bw)
1	135	160	19
2	135	150	11
3	145	105	-28
4	140	- (dead)	-
5	145	160	10
Mean*	140	143.74	3

 *Calculations based only on surviving animals

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.