sodium;2-hexadecylsulfanyl-1H-benzimidazole-5-sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Japanese test guidelines (2000)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

sodium;2-hexadecylsulfanyl-1H-benzimidazole-5-sulfonate

EC Number:

616-081-6

Cas Number:

743423-33-8

Molecular formula:

C23 H37 N2 Na O3 S2

IUPAC Name:

sodium;2-hexadecylsulfanyl-1H-benzimidazole-5-sulfonate

impurity 1

Reference substance name:

1-hexadecyl-2-hexadecylsulfanyl-benzimidazole-5-sulfonate sodium salt

Molecular formula:

C39 H69 N2 Na O3 S2

IUPAC Name:

1-hexadecyl-2-hexadecylsulfanyl-benzimidazole-5-sulfonate sodium salt

impurity 2

Reference substance name:

N,N-dimethylacetamide

EC Number:

204-826-4

EC Name:

N,N-dimethylacetamide

Cas Number:

127-19-5

Molecular formula:

C4H9NO

IUPAC Name:

N,N-dimethylacetamide

impurity 3

Reference substance name:

Ethyldiisopropylamine

EC Number:

230-392-0

EC Name:

Ethyldiisopropylamine

Cas Number:

7087-68-5

Molecular formula:

C8H19N

IUPAC Name:

N-ethyl-N-isopropylpropan-2-amine

Test material form:

solid: particulate/powder

Remarks:

off-white powder with lumps

Details on test material:

Traces of 1-bromohexadecane

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Details on test animals:
Young adult animals (approx. 11 weeks).
Body weight variation <20% of the sex mean.
Identificatin by earmark

Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +- 3.0°C (actual range: 19.1 —22.6°C), a relative humidity of 30-70% (actual range: 35 - 72%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.

Accommodation
Group housing of 3 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm.) containing purified sawdust as bedding material (Woody Clean bedding, Tecnilab—BMl BV, Someren, The Netherlands) and paper as cage-enrichement (Enviro—dri, BMI, Helmond, The Netherlands).
Certificates of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage,
Germany). Certificates of analysis were examined and then retained in the NOTOX archives.

Water
Free access to tap-water. Certificates of quarterly analysis were examined and then retained in the NOTOX archives.

Results of analysis for ingredients and/or contaminants of diet, sawdust, and water were
assessed and did not reveal any findings that were considered to have affected study integrity.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Propylen glycol (specific gravity 1,036)

Remarks:

The vehicle was selected based on trial formulations at NOTOX

Doses:

single dosage of 2000 mg/kg (10 ml/kg) body weight on day 1

No. of animals per sex per dose:

3

Control animals:

no

Statistics:

No statistical analysis was performed (the method used is not intented to allow the calculation of a precise LD50 value)

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

Hunched posture, uncoordinated movements were noted among the animals on day 1. In one animal tremor was noted on day 1 and on day 13 chromodacryorrhoea was noted in one animal.

Body weight:

The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
The incidence of slight body weight loss or reduced body weight gain between days 8 and 15 in individual animals were considered not indicative of toxicity, based on the absence of any corroborative findings in these animals.

Gross pathology:

In one animal lobe infraportalis (diaphragmatic hernia) and enlarged mandibular lymph nodes at both sides were noted at macroscopic post mortem examination. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Does not have to be classified
No obligatory labelling requirement for oral toxicity