Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD 402)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]:Octyltin tris(2-EHMA) [CAS No. 27107-89-7] (mixture 90:10%)

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:no data
- Age at study initiation:no data
- Weight at study initiation: 221-261 g
- Fasting period before study:no data
- Housing: individually
- Diet (e.g. ad libitum): not precised, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
none
Details on dermal exposure:
The dose volume applied was 2 ml/kg bw.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males, 5 females)
Control animals:
no
Details on study design:
Prior to exposure, an area on the back of each test animal (~ >=10% of body surface) was shaved.
After 24 hours, the exposed skin was cleaned and the area of application was observed for 14 days.
Body weights were recorded on days 0 (prior to dosing), 7, and 14. Animals were observed once or twice daily for clinical signs of toxicity and mortality over the exposure period. Animals were sacrificed and necropsied at death or at the end of the exposure period, whichever came first.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no mortality
Mortality:
No mortality was observed over the course of this study. 
Due to the lack of observed mortality, the 14-day acute dermal LD50s of the test substance were reported as:
LD50 (males) = >2000 mg/kg bw
LD50 (females) = >2000 mg/kg bw
LD50 (both sexes) = >2000 mg/kg bw
Clinical signs:
On the day of application, all test animals (both sexes) exhibited slight piloerection. On days 1 and 2 post-application, all animals (both sexes) exhibited erythema at the application site. All clinical symptoms of toxicity disappeared by day 3 post-application.
Gross pathology:
No substance-related gross organ changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
Conclusions:
The acute dermal toxicity LD50 (rat) of DOT(2-EHMA),  >2000 mg/kg bw (both sexes).
Executive summary:

An acute dermal toxicity to rat study (OECD 402) was carried out with a mixture of DOT(2 -EHMA) and Octyltin tris(2-EHMA) (90:10 % w/w). The test dose was 2000 mg/kg bw; the dose volume applied was 2  ml/kg bw.  After 24 hours, the exposed skin was cleaned and the area of  application was observed for 14 days. Due to the lack of observed mortality, the 14-day acute dermal LD50s of  the test substance were reported as: LD50 (males) >2000 mg/kg bw LD50 (females) >2000 mg/kg bw LD50 (both sexes) >2000 mg/kg bw. Based on these results classification is not required.