Bis(neodecanoyloxy)dioctylstannane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July - August 2018

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)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(neodecanoyloxy)dioctylstannane

EC Number:

269-595-4

EC Name:

Bis(neodecanoyloxy)dioctylstannane

Cas Number:

68299-15-0

Molecular formula:

C36H72O4Sn

IUPAC Name:

Neodecanoic acid, 1,1'-(dioctylstannylene) ester

Test material form:

liquid: viscous

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
16JSVA015
- Expiration date of the lot/batch:
14. September 2018
- Purity test date:
not state

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Room Temperature: (20 ± 5°C), keep container tightly closed, store under inert gas
- Stability under test conditions:
assumed stable


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 190 - 200 g
- Fasting period before study: over night
- Housing: in gorups of 3
- Diet (e.g. ad libitum): The laboratory food ssniff (Spezialdiäten GmbH, Germany) was
offered at recommended doses each day approximately at the same
time.
- Water (e.g. ad libitum): Supply of
drinking was unlimited.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.7 ± 0.7° C,
- Humidity (%): 55.1 ± 3.1 %.
- Air changes (per hr): central air conditioning, no value given
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not stated
- Amount of vehicle (if gavage): not stated
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): L61067
- Purity: not applicable

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days ´
- Frequency of observations:
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
and weighing:
Individual weights of animals were measured immediately prior to test item was administered and
weekly thereafter. Weight differences after first and second weeks after administration were
calculated and recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Statistics:

none applied

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Five of six females survived the limit dose of 2000 mg/kg body weight.
Female No 6 was
lethargic from Day 5 to Day 12 and died on Day 13 post-treatment.

Clinical signs:

other: Lethargy and sleepiness between 0.5 and 4 hours after treatment was observed in all animals. These observations in animals No 1, 2 and 3 were noticed on Day 1 post-treatment too. Female No 6 was lethargic from Day 5 to Day 12 and died on Day 13 post-treat

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed in females
No 1-5. Adrenomegaly, petechial haemorrhages on the gastric mucosa in female No 6 were registered.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item Bis(neodecanoyloxy)dioctylstannane is greater than 2000 mg/kg body
weight after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item

Bis(neodecanoyloxy)dioctylstannane when administered as a single oral dose to Wistar rats. The

procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.

Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of

2000 mg/kg body weight was used as a starting dose.

One group of 3 females was dosed. Due to lethargy of all animals, next step proceeded after 7 days.

Test item-related mortality was not observed during 7 days; another 3 females were treated with the

same dose.

Five females survived the limit dose. One female died on Day13 post-treatment. Lethargy and

sleepiness between 0.5 and 4 hours after treatment was observed in all animals. These observations

in animals No 1, 2 and 3 were noticed on Day 1 post-treatment too. From Day 5 to Day 12 female No

6 was lethargic and this animal died on Day 13 post-treatment.

During post-treatment time, the rest animals displayed neither signs of intoxication, change of health,

nor any other adverse reaction. Stagnation of the body weight in 4 animals, slight increase of the body

weight in 1 animal and decrease of the body weight in 1 animal between the first and second week

were observed.

During necropsy, no macroscopic findings were observed in 5 females. In died female adrenomegaly,

petechial haemorrhages on the gastric mucosa were registered.

The LD50 of the test item Bis(neodecanoyloxy)dioctylstannane 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 Bis(neodecanoyloxy)dioctylstannane is classified

in GHS Category 5 (> 2000 – 5000) with a LD50 cut off value equal to 2500 mg/kg body weight, after

single oral administration to Wistar rats.