Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29 January 2016 to 29 February 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 420. The study was conducted on the registered substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-aminoethanol and 6-[(p- tosyl)amino] hexanoic acid, compound with 2- aminoethanol (1:1)

IUPAC Name:

Reaction mass of 2-aminoethanol and 6-[(p- tosyl)amino] hexanoic acid, compound with 2- aminoethanol (1:1)

Constituent 2

Reference substance name:

Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)

EC Number:

942-732-1

Molecular formula:

C13H19NO4S.C2H7NO/C2H7NO/H2O

IUPAC Name:

Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1)

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino] hexanoic acid, compound with 2-aminoethanol (1:1)- Physical state: Pale yellow liquid- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Envigo RMS (UK) Limited- Age at study initiation: 8-12 weeks- Weight at study initiation: 155-174g- Fasting period before study: overnight prior to dosing and 3 to 4 hours after- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes- Diet: ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-25- Humidity (%): 30-70- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

For the purpose of the study the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.

Doses:

2000mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical observations at 30 minutes, 1, 2 and 4 hours after dosing then daily. Body weights recorded on days 0, 7 and 14- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Noisy respiration noted in one animal 9-11 days after dosing

Body weight:

All animals showed expected body weight gains

Gross pathology:

No abnormalities noted

Any other information on results incl. tables

Individual Clinical Observations and Mortality Data

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing				Effects Noted During Period After Dosing (Days)
		1/2	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1 -0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2 -0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2 -1 Female	0	0	0	0	0	0	0	0	0	0	0	0	Rn	Rn	Rn	0	0	0
	2 -2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2 -3 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0= No signs of systemic toxicity

Rn= Noisy respiration

Individual Body Weights and Body Weight Changes

Dose Level mg/Kg	Animal Number and Sex	Body Weight (g) at Day			Body Weight Gain (g) During Week
		0	7	14	1	2
2000	1 -0 Female	155	181	195	26	14
	2 -0 Female	174	186	199	12	13
	2 -1 Female	172	181	194	9	13
	2 -2 Female	167	180	190	13	10
	2 -3 Female	174	189	197	15	8

Individual Necropsy Findings

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2000	1 -0 Female	Killed Day 14	No Abnormalities Detected
	2 -0 Female	Killed Day 14	No Abnormalities Detected
	2 -1 Female	Killed Day 14	No Abnormalities Detected
	2 -2 Female	Killed Day 14	No Abnormalities Detected
	2 -3 Female	Killed Day 14	No Abnormalities Detected

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The acute toxicity study by oral route was conducted on the registered substance according to OECD Testing Guideline 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Executive summary:

The acute toxicity: oral of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 420.

Following a sighting test at dose level 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There was no mortality, all animals showed expected gains in body weight over the observation period and no abnormalities were noted at necropsy. The only clinical observations observed was one animal showed noisy respiration between days 9 and 12. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.