Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
other: National guideline study with acceptable restrictions.

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

Constituent 1
Chemical structure
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 dodecanoate
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: wax-like
- Analytical purity: no data
- Other: for the experiment, the test substance was diluted in olive oil to a concentration of 50%. The dilution had a pH value of 6.0.

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
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified