2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2nd December - 16th December 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

248-227-6

EC Name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

27107-89-7

Molecular formula:

C38H74O6S3Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Constituent 2

Reference substance name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (purity: 97.9%)

IUPAC Name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (purity: 97.9%)

Details on test material:

Date of receipt : 17 November 2009
Test material name : Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE)
Other name : Thermolite 9XX
Lot number : ESOC21.20092
Storage conditions : 2-10°C in the dark. Air space flushed with nitrogen.
Appearance : clear colorless liquid
Purity : 97.9% (see Annex 1)
Expiry date : 13 November 2010
TNO dispense number : 090148

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: ca. 8 weeks old at start of study
- Weight at study initiation: 215 - 251 g. Mean weight was 237 g.
- Fasting period before study: NDA
- Housing: a maximum of 5 animals/sex per macrolon cage with sterilised wood shavings (Woody Clean) as bedding material and environmental enrichment (shreds of paper); individual housing during dermal exposure.
- Diet (e.g. ad libitum): standard laboratory diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: mimimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 45-65%. Upper limit may be higher for short periods of time, because of meteorological circumstances and/or wet cleaning of the room.
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark


IN-LIFE DATES: From: 2nd December 2009 To: 16th December 2009

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 20 cm^2
- % coverage: at least 10 % of body surface
- Type of wrap if used: gauze affixed with tape wrapped around the trunk of the rat

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: ca. 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.79 mL/kg bw. equivalent to 2000 mg/kg bw
- Concentration (if solution): N/A
- Constant volume or concentration used: constant concentration of test substance per kg bw.
- For solids, paste formed: N/A

VEHICLE
- N/A

Duration of exposure:

Ca. 24 hours

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of each animal was recorded just prior to dosing and of each surviving animal on days 3, 7 and 14 of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal reactions, macroscopial findings

Statistics:

No statistics reported.

Results and discussion

Preliminary study:

NDA

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed during the 14-day study period.

Clinical signs:

other: No clinical signs were observed during the 14-day study period.

Gross pathology:

Examination at necropsy of the animals did not reveal distinct treatment related gross alterations.

Other findings:

In general, no signs of skin irritation were observed during the study. On days 1 and/or 3, three females showed minor skin effects, consisting of very slight or well-defined erythema and very slight or slight scaliness.

Any other information on results incl. tables

Table 1. Individual and mean bodyweights, dose amounts applied and mortality data.

Animal number	Sex	Dose (ml) applied	Bodyweights (g) recorded on day:				Mortality
			0	3	7	14
12	Male	0.38	215	203	230	262	-
14		0.45	251	255	281	315	-
16		0.43	238	241	266	298	-
18		0.43	241	231	260	281	-
20		0.43	242	244	267	300	-
Mean bodyweight			237	235	261	291	0/5
11	Female	0.32	180	174	191	211	-
13		0.32	181	183	199	211	-
15		0.29	163	154	177	189	-
17		0.32	180	162	188	206	-
19		0.31	174	171	190	213	-
Mean bodyweight			176	169	189	206	0/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Since all animals survived the 2000 mg/kg dose level, the dermal LD50 of Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) is considered to be higher than 2000 mg/kg body weight.

Executive summary:

Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was examined for acute dermal toxicity in an experiment with 8 week old male and female Wistar rats (limit testing), according EEC Directive 96/54/EEC, method B.3 and OECD Guideline no. 402. A dose level of 2000 mg per kg body weight was examined and the dermal contact period was 24 hours.

Since all animals survived the 2000 mg/kg dose level, the dermal LD50 of Octyltin tris(2-ethylhexylmercaptoacetate) is considered to be higher than 2000 mg/kg body weight.