Disodium 1,5-dihydroxypentane-1,5-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 15 AUG 2017 to 30 AUG 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1,5-dihydroxypentane-1,5-disulphonate

Cas Number:

7420-89-5

Molecular formula:

C5H10Na2O8S2

IUPAC Name:

Disodium 1,5-dihydroxypentane-1,5-disulphonate

impurity 1

Reference substance name:

Sodium sulfate

Cas Number:

7757-82-6

IUPAC Name:

Sodium sulfate

impurity 2

Reference substance name:

Sodium hydrogen sulfite

Cas Number:

7631-90-5

IUPAC Name:

Sodium hydrogen sulfite

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

6 females, 8-12 weeks, animals were non-pregnant and nulliparous.
Health condition of animals was examined by a veterinarian before initiation of the study.
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning. The average room temperature was maintained within the range of 23.18 ± 0.45° C, relative humidity within 55.40 ± 3 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test item administration, food was withheld for further 3-4 hours.

Doses:

Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose.

No. of animals per sex per dose:

One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.

Details on study design:

Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days. Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
All test animals were subjected to gross necropsy and the results were recorded for each animal.

Statistics:

The Acute Toxic Class Method is not designed to determine a point estimate of LD50. It provides a range estimate of LD50 defined by cut-off values of the applied classification system and not as a calculated lower and upper level.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.

Clinical signs:

other: No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

other: Category 5 or Unclassified

Conclusions:

The LD50 of the test item Glutardialdehyde bis-Sodiumbisulfite is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Glutardialdehyde bis-Sodiumbisulfite is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The test item Glutardialdehyde bis-Sodiumbisulfite administered to 6 females at a limit dose of 2000 mg/kg body weight did not cause death. No signs of toxicity were observed during the first 4 hours in females or the 14-day observation period thereafter. The body weights of all animals increased during the study. No body weight losses were observed between the first and second week after administration of the test item. During necropsy, no macroscopic findings were observed.