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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-04-04- to 2011-04-19

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

other: White Wistar, HsdCpb: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 7 weeks at delivery, approx. 8 weeks at day of application
- Weight at study initiation: 186.2 ± 8.4 g (female) and 213.9 ± 6.7 (male) at day of application
- Housing: One rat was housed in a Makrolon cage type III
- 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: 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10 %
- Type of wrap if used:
The test substance was applied uniformly over the test site (approx. 10 % of the body surface area), covered with a gauze pad (4 x 5 em, Brauncel, B. Braun Petzold GmbH, Melsungen, Germany) which was held in place by strips of Micropore (3M company, St. Paul, USA). The dressing was bandaged with Acrylastic (Beiersdorf AG, Hamburg, Germany) and fixed with Leukoplast (Beiersdorf AG, Hamburg, Germany).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (Density 1.19 g/cm³)
- Concentration (if solution): undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): undiluted

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Clinical examination was performed immediately, 1 hour and 4 hours after test substance administration and thereafter daily except on Saturdays and Sundays. Determination of body weights took place before dosing, after 7 days and 14 days.

- Necropsy of survivors performed: yes;
After completion the test animals were sacrificed with carbon dioxide and necropsied.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: no animal died

Mortality:

All animals survived until the termination of the experiment 14 days p.a.

Clinical signs:

other: No signs of irritation or other clinical signs were observed.

Gross pathology:

The necropsy of all animals 14 days after application showed no macroscopic visible test substance related pathologic organ findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

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

Conclusions:

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

Executive summary:

In an acute dermal toxicity study according to OECD guideline 402, 1987 and EU method B.3, 5 male and 5 female young adult white Wistar rats were dermally exposed to the hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) for 24 hours under an occlusive dressing to approx. 10 % of body surface area at doses of 2000 mg/kg bw. Animals then were observed for14 days.

 

Dermal LD₅₀            Males:             > 2000 mg/kg bw

                                 Females:          > 2000 mg/kg bw

                                 Combined:      > 2000 mg/kg bw

 

No mortality occurred in this limit test.

 

No signs of skin irritation were observed at the site of application. Symptoms of systemic toxicity or unusual findings were not recorded at any time during the study. Weight gain was positive within normal range. No macrospic visible substance related pathologic organ findings were noted at terminal necropsy.