Sodium 2-hydroxy-3-[(2-hydroxyethyl)[2-[(1-oxo-9-octadecenyl)amino]ethyl]amino]propanesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-01-29 to 1992-02-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit

Molecular formula:

not available for UVCB

IUPAC Name:

Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 5 - 8 weeks old
- Weight at study initiation: males: 126 - 140 g; females: 126 - 134 g
- Fasting period before study: Yes
- Housing: In groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 53 - 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

2000 mg/kg bw (Dose volume: 1.74 ml/kg bw)

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, other toxicological effects

Results and discussion

Preliminary study:

There were no deaths or clinical signs of toxicity. The results of the range-finding study indicated that the acute oral median lethal dose of the test item was greater than 2000 mg/kg bw. Based on this information, a dose level of 2000 mg/kg bw was selected for the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

Individual clinical observations and mortality data are given in section "Any other information on results incl. tables"

Body weight:

All animals showed expected gain in bodyweight during the study.

Gross pathology:

No abnormalities were noted at necroscopy.

Other findings:

None

Any other information on results incl. tables

Table: Individual clinical observations and mortality data in the main study

Dose Level mg/kg bw	Animal Number & Sex	Effects Noted After Dosing (Hours)				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	3-0 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-1 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-2 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-3 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3-4 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4-2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4-3 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4-4 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

Table 2: Individual bodyweights and weekly bodyweight gain in the main study

Dose Level mg/kg	Animal Number & Sex	Bodyweight (g) at Day			Bodyweight Gain (g)	During Week
		0	7	14	1	2
2000	3-0 Male	137	216	270	79	54
	3-1 Male	134	202	254	68	52
	3-2 Male	132	209	267	77	58
	3-3 Male	140	209	261	69	52
	3-4 Male	126	194	254	68	60
	4-0 Female	129	170	197	41	27
	4-1 Female	126	174	206	48	32
	4-2 Female	127	164	197	37	33
	4-3 Female	134	187	221	53	34
	4-4 Female	128	169	186	41	17

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item in the Spraque-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

A study was performed to assess the acute oral toxicity of the test item in the Spraque-Dawley strain rat according to OECD Guideline 401 and in compliance with GLP principles. Following a range finding study, a group of ten fasted animals, five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bw. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination. In result, there were no deaths. No signs of toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. Thus, the LD50 of the test item was determined to be greater than 2000 mg/kg bw. The test is regared to be valid.