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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 January 2013 to 30 January 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
potassium (2S)-4-carboxy-2-tetradecanamidobutanoate
EC Number:
700-938-7
Cas Number:
72716-26-8
Molecular formula:
C19H34NO5K
IUPAC Name:
potassium (2S)-4-carboxy-2-tetradecanamidobutanoate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: White powder
- Storage condition of test material: Room temperature (15-25 °C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: CRL:(WI)
- Age at study initiation: Young healthy adult rats, 9 – 10 weeks old.
- Weight at study initiation: 202 – 211 g
- Fasting period before study: Overnight.
- Housing: Standard housing conditions, in groups of three per cage. Type II polypropylene/polycarbonate cages were used.
- Diet: Complete diet for rats and mice was provided ad libitum.
- Water: Tap water from the municipal supply was provided ad libitum.
- Acclimation period: at least 12 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 – 21.9 °C
- Humidity (%): 34 – 66 %
- Air changes (per hr): 15 – 20 air exchanges/hour.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From: 15 January 2013 To: 30 January 2013.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: The test material was freshly formulated at a concentration of 200 mg/mL in the vehicle, on the day of administration. The formulation container was stirred continuously up to finishing the treatment.

CLASS METHOD
- Rationale for the selection of the starting dose: The initial dose level was selected by the study director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Two groups of three females were dosed.
Control animals:
no
Details on study design:
- Dosing procedure: Initially, three females (Group 1) were dosed, and then based on the observations a further group of three females (Group 2) were dosed.
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
> Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> Body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: Yes, macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in either Group 1 or 2.
Clinical signs:
other: Treatment at the dose level of 2000 mg/kg bw caused vocalisation (3/6), hunched back (6/6), irritability (3/6). Group 1 was symptom free from 6 hours after the treatment and Group 2 was symptom free from one day after the treatment. See Table 1 for result
Gross pathology:
There was no evidence of any gross findings at a dose level of 2000 mg/kg bw.

Any other information on results incl. tables

Table 1: Clinical Observations

Group No.

Animal No.

Observation

Observation Time

Frequency

30 min

1 h

2 h

3 h

4 h

6 h

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7-14

1

8897

Symptom Free

-

-

-

-

-

+

+

+

+

+

+

+

+

15/20

Vocalisation

+

+

+

-

-

-

-

-

-

-

-

-

-

3/20

Irritability

1

1

-

-

-

-

-

-

-

-

-

-

-

2/20

Hunched Back

+

+

+

+

+

-

-

-

-

-

-

-

-

5/20

8898

Symptom Free

-

-

-

-

-

+

+

+

+

+

+

+

+

15/20

Vocalisation

+

+

-

-

-

-

-

-

-

-

-

-

-

2/20

Irritability

1

1

-

-

-

-

-

-

-

-

-

-

-

2/20

Hunched Back

+

+

+

+

+

-

-

-

-

-

-

-

-

5/20

8899

Symptom Free

-

-

-

-

-

+

+

+

+

+

+

+

+

15/20

Vocalisation

+

+

-

-

-

-

-

-

-

-

-

-

-

2/20

Irritability

1

1

-

-

-

-

-

-

-

-

-

-

-

2/20

Hunched Back

+

+

+

+

+

-

-

-

-

-

-

-

-

5/20

2

8900

Symptom Free

-

-

-

-

-

-

+

+

+

+

+

+

+

14/20

Hunched Back

+

+

+

+

+

+

-

-

-

-

-

-

-

6/20

8901

Symptom Free

-

-

-

-

-

-

+

+

+

+

+

+

+

14/20

Hunched Back

+

+

+

+

+

+

-

-

-

-

-

-

-

6/20

8902

Symptom Free

-

-

-

-

-

-

+

+

+

+

+

+

+

14/20

Hunched Back

+

+

+

+

+

+

-

-

-

-

-

-

-

6/20

+ = present; - = absent

Frequency of observations = number of occurance of observation/ total number of observations

Severities: 1 = Slight/Small/Few; 2 = Moderate/Medium; 3 = Market/Large/Many

 

Table 2: Body Weight

Group No.

Animal No.

Body weight (g)

Day

Body Weight Gain (g)

Days

-1

0

7

14

-1 - 0

0 - 7

7 - 14

-1 - 14

1

8897

223

208

235

265

-15

27

30

42

8898

223

210

229

242

-13

19

13

19

8899

215

202

226

244

-13

24

18

29

2

8900

218

211

237

245

-7

26

8

27

8901

211

202

244

249

-9

42

5

38

8902

205

195

228

234

-10

33

6

29

Mean:

215.8

204.7

233.2

246.5

-11.2

28.5

13.3

30.7

Standard Deviation:

7.1

6.1

6.8

10.3

3.0

8.0

9.5

8.2

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of the study, the acute oral LD50 of the test material was determined to be > 2000 mg/kg bw in female Wistar rats.
Executive summary:

The acute oral toxicity of the test material was determined in a GLP study conducted in line with OECD 423, EU Method B.1 tris and EPA OPPTS 870.110, according to the acute toxic class method.

A total of six fasted female Wistar rats were exposed to the test material at 2000 mg/kg bw by oral gavage. Individuals were observed for mortality, clinical signs of toxicity, bodyweight gain and then submitted for necropsy 14 days after exposure.

Initially, three female animals were treated with the test material at 2000 mg/kg bw. No mortality was observed, therefore further 3 animals were treated at the dose level of 2000 mg/kg bw. As no mortality was observed in this second dose group, further testing was not required according to the test guidelines.

Under the conditions of the test no mortality was observed, individual weight gain showed no signs of treatment related effects, and t here was no evidence of any gross findings at necropsy. Clinical signs were observed in some individuals, vocalisation (3/6), hunched back (6/6), irritability (3/6). However, Group 1 was symptom free from 6 hours after the treatment and Group 2 was symptom free from one day after the treatment.

Based on these observations the acute oral LD50 of the test material was determined to be > 2000 mg/kg bw in female Wistar rats.