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

Endpoint summary

Description of key information

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.

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:

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.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study was considered as fully reliable as it was conducted on the registered substance, as defined in section 1.1.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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 levels of 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. At dose 2000 mg/kg there was no mortality, all animals showed expected gains in body weight and no abnormalities were noted at necropsy. One animal showed noisy respiration 9-11 days after dosing. 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.

Justification for selection of acute toxicity – oral endpoint
This study was selected as the key study as it was a GLP study conducted on the registered substance according to OECD Testing Guideline 420. The LD50 was >2000mg/kg bw.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.

Justification for selection of acute toxicity – dermal endpoint
In accordance with REACH, Annex XI, no testing is required as no significant dermal exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.

Justification for classification or non-classification

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.