Sodium 2-[(2-aminoethyl)amino]ethanesulphonate

Toxicity to reproduction

Administrative data

Endpoint:

toxicity to reproduction

Remarks:

other: subacute study

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 407

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-[(2-aminoethyl)amino]ethanesulphonate

EC Number:

252-173-9

EC Name:

Sodium 2-[(2-aminoethyl)amino]ethanesulphonate

Cas Number:

34730-59-1

Molecular formula:

C4H12N2O3S.Na

IUPAC Name:

sodium 2-(2-aminoethylamino)ethanesulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

The application volume was 10 mL/kg bw.

Details on mating procedure:

not applicable because it is a subacute study

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

The test item AAS-Loesung is a 48.8% solution in water. Dilution in water is therefore expected not to influence the stability of the test item. The stability of the formulations was declared by the sponsor as at least 8 days.

Duration of treatment / exposure:

29 days

Frequency of treatment:

once daily

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw and day
Basis:
other: solid content of AAS-Loesung (48.8%)

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0, 205, 615, 2050 mg/kg bw and day
Basis:
other: AAS-Loesung

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Based on:

other: solid content of AAS-Loesung (48.8%)

Sex:

male/female

Basis for effect level:

other: no adverse effects on reproductive organs or tissues

Remarks on result:

other: Generation: not applicable because it is a subacute study (migrated information)

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No adverse effects on reproductive organs or tissues were observed in a subacute oral study with rats up to and including 1000 mg/kg and bw.

Executive summary:

In a repeated dose toxicity study in rats (Wistar, OECD TG 407) the substance was administered via gavage to 5 rats/sex/dose at 0, 100, 300, 1000 mg/kg bw in demineralized water for 4 weeks. Up to and including 1000 mg/kg bw no mortality, treament related clinical signs or other toxicological relevant effects occured. Neither gross pathological nor histopathological changes of organs, including the male and female reproductive organs (testes, epididymides, prostate, seminal vesicles incl. coagulation glands, ovaries with oviducts, uterus with cervix, vagina, mammary glands) were reported at any exposure concentration, including the limit dose of 1000 mg/kg bw. Overall, based on the subacute toxicity study there is no indication of a reproductive toxicity potential of AAS and the NOAEL for reproductive effects for male and female rats can be considered as 1000 mg AAS/kg bw.