N-(carbamoylmethyl)taurine

Endpoint summary

Description of key information

In a reliable in vivo acute oral toxicity study, the substance was administered to 6 female Wistar rats in a single dose by oral gavage at a limit dose of 2000 mg/kg body weight. All (6/6 females) animals survived the dose of 2000 mg/kg body weight.The substance did not cause death or evident signs of toxicity. During the observation period of 14 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The oral LD₅₀of the substance is considered to be greater than 2000 mg/kg body weight after single oral administration to female Wistar rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12th November 2018 - 27th November 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17th December 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment

Version / remarks:

No 24, 2001

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment

Version / remarks:

No 19, 2000

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Lot Number: GL865320171205
Composition: 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
CAS No: 7365-82-4
Molecular formula: C4H10N2O4S
Purity: >=99% Assay (Titration)
Appearance: White crystalline powder
Homogeneity: homogeneous
Production Date: 5th December 2017
Expiry Date: 5th December 2019
Storage: Room Temperature (20 ± 5 °C)

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Female animals were non-pregnant and nulliparous, 8-12 weeks of age at first dose.
Health condition of animals was examined by a veterinarian before initiation of the study.
The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22 ± 3 ° C, relative humidity within 50-60 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time.
The animals received tap water for human consumption. Drinking water was supplied ad libitum.
The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the substance.

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The substance was administered in a single dose by gavage using a metal stomach tube (administration volume 5 mL/kg). Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the substance administered. After substance administration, food was withheld for further 3-4 hours.

Doses:

Single dose of 2000 mg/kg body weight.

No. of animals per sex per dose:

6 females (3/step)

Control animals:

no

Details on study design:

Available information indicated that the substance is likely to be non-toxic with regard to acute toxicity.A limit dose of 2000 mg/kg body weight was therefore used as a starting dose. One group of 3 females was dosed. Substance-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose level.
The required amount of the substance (according to the body weight) was mixed with vehicle (olive oil) shortly before administration. The substance was administered in a single dose by gavage using a metal stomach tube (administration volume 5 mL/kg). Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the substance administered. After substance administration, food was withheld for further 3-4 hours.
Animals were observed individually immediately after administration of the substance and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Individual weights of animals were measured immediately prior to substance administration and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
All test animals were subjected to gross necropsy and the results were recorded for each animal.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.

Clinical signs:

other: No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Clinical Observation

Sex	Dose	ID	Administration Result	Clinical Observation
♀	2000 mg/kg	1	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		2	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		3	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		4	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		5	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period
		6	alive	no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period

Body Weight

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1-Initial	Week 2-Initial	Week 2-Week 1
♀	2000 mg/kg	1	203	217	229	14	26	12
		2	200	215	222	15	22	7
		3	207	203	208	- 4	1	5
		4	225	234	241	9	16	7
		5	224	234	243	10	19	9
		6	223	237	244	14	21	7

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 in an acute toxicity study conducted on the substance in female rats administered via gavage is >2000 mg/kg bw.

Executive summary:

In a reliable in vivo acute oral toxicity study, the substance was administered to 6 female Wistar rats in a single dose by oral gavage at a limit dose of 2000 mg/kg body weight. All (6/6 females) animals survived the dose of 2000 mg/kg body weight. The substance did not cause death or evident signs of toxicity. During the observation period of 14 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The LD₅₀of the substance is considered to be greater than 2000 mg/kg body weight after single oral administration to female Wistar rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Sufficient to address requirements.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings of a reliable acute oral toxicity study conducted on the substance, classification of the substance is not justified.