L-Glutamic acid, N-coco acyl derivs., compds. with triethanolamine (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 November 1986 to 28 November 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

other: Read-across target

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For the justification for read-across, please refer to the read-across assessment framework report that is attached to Section 13.

Reason / purpose for cross-reference:

read-across source

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 - <= 10 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

other: Not classified according to EU criteria.

Conclusions:

Under the conditions of the test, the acute oral LD50 was > 5.0 g/kg body weight and < 10.0 g/kg body weight.

Executive summary:

The test material was administered once orally to mice in dosages of 5.0 g/kg, 10.0 g/kg and 20.0 g/kg.

Immediately after administration, a decrease in locomotor activity and diarrhoea were observed in the group that was administered 5.0 g/kg. One animal in this group died the second day after administration but the other 4 animals recovered. In the groups that were administered 10.0 g/kg and 20.0 g/kg, a decrease in locomotor activity, diarrhoea, and discharge of the substance administered from the naris were observed. In the group that was administered 20.0 g/kg, cyanosis, opisthotonus, and convulsions were also observed. Afterwards, all animals in the groups that were administered 10.0 g/kg and 20.0 g/kg died.

Based on the above, it was suggested, LD50 for this compound is greater than 5.0 g/kg body weight, less than 10.0 g/kg body weight.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was administered once orally to 20 male mice in dosages of 5.0 g/kg, 10.0 g/kg and 20.0 g/kg. A volume of 0.67 mL of the sample to be administered per 10 g of body weight was orally administered to the animals into their stomachs using gastric catheters.
Clinical signs, mortality and body weight were assessed during the study and necropsies performed on all animals.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

TEA Lauroyl L-Glutamate

IUPAC Name:

TEA Lauroyl L-Glutamate

Test material form:

liquid

Test animals

Species:

mouse

Strain:

CD-1

Remarks:

ICR (Crl: CD-1)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4 weeks oldon arrival, 5 weeks old at the time the test material was administered.
- Weight at study initiation: 25.2 to 29.3 g
- Fasting period before study: The animals were fasted for approximately 8 hours before administration. Feeding resumed 2 hours after administration.
- Housing: Polyethylene cages with 5 animals in each cage.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3 ± 3 °C
- Humidity (%): 55 ± 5 %
- Air changes (per hr): 12 cycles per hour (all-fresh air system)
- Photoperiod (hrs dark / hrs light): 12 hours light:dark with light intensity of between 200 and 500 lx.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test material was dissolved in distilled water, and solutions of 7.5 %, 15.0 %, and 30.0 % were prepared immediately before administration.

MAXIMUM DOSE VOLUME APPLIED: 0.67 mL per 10 g of body weight was administered, representing that dosages of 5.0 g/kg, 10.0 g/kg, and 30.0 g/kg, of the test material were administered, respectively.

Doses:

5.0 g/kg, 10.0 g/kg, and 30.0 g/kg.

No. of animals per sex per dose:

20 males

Control animals:

yes

Remarks:

The vehicle (distilled water)

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: From the day of administration (Day 1) until Day 8, observations were made once a day as to whether there were any deaths of the animals. On Day 1, observation of acute toxicity symptoms was continuously conducted, starting immediately after administration for approximately 2 hours. Observation of clinical signs was also conducted on Day 1 before administration and once a day between Day 2 and Day 8.
The body weight of all surviving animals was measured on Days 1, 2, 6, and 8.
Dates were counted based on Day 1 being the day that administration was carried out.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight,organ weights.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 - <= 10 000 mg/kg bw

Based on:

test mat.

Mortality:

During the study period, it was confirmed that upon orally administering the test material once to mice, there was 1 death on the 2nd day after administration (Day 3) in the group that was administered 5.0 g/kg. In addition, in the groups that were administered 10.0 g/kg and 20.0 g/kg, symptoms thought to be resulting from administration were observed immediately after administration, and all of the animals died.

Clinical signs:

other: Upon orally administering the test material once to mice, a decrease of locomotor activity and diarrohea were observed immediately after administration in the group that was administered 5.0 g/kg, and the death of 1 animal was confirmed on Day 3. The othe

Gross pathology:

Upon conducting necropsy examinations of the animals that died immediately after administration, haemorrhaging was found in the stomach or the intestinal tract of all animals, and there was also accumulation of water fluid in the intestinal tract. Upon conducting necropsy examinations of the surviving animals on the 7th day after administration, there were no abnormal findings for any of the animals.

Any other information on results incl. tables

Macroscopic findings

Dose (g/kg)	Sex	Animal No.	Type of death	Findings
0	Male	1	S	-
		2	S	-
		3	S	-
		4	S	-
		5	S	-
5.0	Male	1	S	-
		2	S	-
		3	D2	C
		4	S	-
		5	S	-
10.0	Male	1	D1	A,B
		2	D1	A,B
		3	D1	A,B
		4	D1	A,B
		5	D1	A,B
20.0	Male	1	D1	A,B
		2	D1	A,B
		3	D1	A,B
		4	D1	A,B
		5	D1	A,B

-: No abnormal findings,

A: Water fluid and haemorrhage in intestine

B: Dehydration (abdominal cavity)

C: No significant gross pathological findings were recorded because of the severe post-mortem change

Type of death:

S: Scheduled

D1: Death (Day 1)

D2: Death (Day 3)

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria.

Conclusions:

Under the conditions of the test, the acute oral LD50 was > 5.0 g/kg body weight and < 10.0 g/kg body weight.

Executive summary:

The test material was administered once orally to mice in dosages of 5.0 g/kg, 10.0 g/kg and 20.0 g/kg.

Immediately after administration, a decrease in locomotor activity and diarrhoea were observed in the group that was administered 5.0 g/kg. One animal in this group died the second day after administration but the other 4 animals recovered. In the groups that were administered 10.0 g/kg and 20.0 g/kg, a decrease in locomotor activity, diarrhoea, and discharge of the substance administered from the naris were observed. In the group that was administered 20.0 g/kg, cyanosis, opisthotonus, and convulsions were also observed. Afterwards, all animals in the groups that were administered 10.0 g/kg and 20.0 g/kg died.

Based on the above, it was suggested, LD50 for this compound is greater than 5.0 g/kg body weight, less than 10.0 g/kg body weight.