Hexanoic acid, 3,5,5-trimethyl-, tin(2+) salt (2:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-11-29 to 2010-12-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

tin(2+) bis(3,5,5-trimethylhexanoate)

EC Number:

700-567-0

Cas Number:

1231728-34-9

Molecular formula:

C18H34O4Sn

IUPAC Name:

tin(2+) bis(3,5,5-trimethylhexanoate)

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 10 weeks at delivery, approx. 11 weeks at day of application
- Weight at study initiation: 202.2 ± 5.8 g (dose group 300 mg/kg) and 207.7 ± 5.9 g (dose group 2000 mg/kg) at day of application
- Fasting period before study: overnight before application
- Housing: Three rats were housed in one Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum, Altromin Rats/mice maintenance diet 1324
- Water (e.g. ad libitum): ad libitum, tap water from municipal source
- Acclimation period: 6 to 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours dimmed light, 12 hours dark

IN-LIFE DATES: From: 2010-11-23 To: 2010-12-15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 % w/w for the 300 mg/kg bw and undiluted for the 2000 mg/kg bw dose
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required): Lot 068K0150

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 females per dose, in a stepweise procedure

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: immediately, 1 hour and 3 hours after test substance administration and thereafter daily
except on one Saturday and one Sunday in the second week p.a.; weighing: before dosing , after 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

300 mg/kg bw - no animal died
2000 mg/kg bw - in the first step no animal died, but in the second step two of the three animals died

Clinical signs:

other: 300 mg/kg bw - no symptoms of toxicity 2000 mg/kg bw : Two animals showed symptoms of toxicity like reduced activity and ventral position. 20 h p.a one of the two animals was found dead; the second one was found morbund (unconscious and with reduced resp

Gross pathology:

The necropsy 14 days after oral application showed no test substance related macroscopic visible pathologic organ findings in the survived animals.
The necropsy of the sacrificed animal 20 h p.a. revealed that the liver was discolored yellowish. No necropsy was performed on the animal found
dead
due to advanced maceration.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The LD50-value for acute oral toxicity of the test substance hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) is > 300 - 2000 mg/kg body weight.

Executive summary:

In an acute oral toxicity study performed according to the OECD Guideline 423, (Acute Toxic Class Method, 2001), 6 female 10 weeks old HanRcc:WIST (SPF) rats per group were given a single oral dose of test substance hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1)

, in sesame oil at doses of 300 and 2000 mg/kg bw and observed for 14 days.The test substance was applied as 10 % (w/w) preparation in vehicle and undiluted.

 

The test substance was tolerated by the test animals at a dose of 300 mg/kg body weight without any symptoms of toxicity. A dose of 2000 mg/kg body weight caused symptoms of toxicity (reduced activity and cower position) in four of six animals and two of these animals died within 20 h following oral administration of the test substance. Body weight development was not negatively affected in all animals that survived.

 

According to the test procedure scheme given in the test guideline the LD₅₀-value for acute oral toxicity of the test substance hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) is > 300 - 2000 mg/kg body weight.