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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2nd December to 16th December 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
other: read-across target
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read Across to Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) (EC Number 248-227-6 and CAS No 27107-89-7) based on structural similarity and hydrolytical behaviour, see attached justification.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
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

Constituent 1
Chemical structure
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
- 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 cm²
- % 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
Key result
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:
No clinical signs were observed during the 14-day study period.
Body weight:
Apart from a slight dip in body weight of some of the animals on day 3 of the study, all animals gained weight during the 14-day study (see Table 1).
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:
other: Not classified in accordance with EU Criteria
Conclusions:
Since all animals survived the 2000 mg/kg dose level, the dermal LD50 of the test material is considered to be higher than 2000 mg/kg body weight.
Executive summary:

The test material was examined for acute dermal toxicity in an experiment with 8 week old male and female Wistar rats (limit testing), according EU Method B.3 and OECD 402, under GLP conditions. 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 the test materuial is considered to be higher than 2000 mg/kg body weight.