Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Mar - 20 Apr 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane
EC Number:
700-957-0
Molecular formula:
UVCB
IUPAC Name:
1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane
Constituent 2
Reference substance name:
Reaction products of trimethoxy(vinyl)silane and 2-methylpropane-1,3-diol (2:5-6)
IUPAC Name:
Reaction products of trimethoxy(vinyl)silane and 2-methylpropane-1,3-diol (2:5-6)
Details on test material:
- Name of test material (as cited in study report): Y-15866
- Physical state: colourless liquid
- Analytical purity: 72%
- Lot/batch No.: 3710-10
- Expiration date of the lot/batch: 2013-07-16
- Stability under test conditions: stability unknown in PEG 300 (vehicle)
- Storage condition of test material: at room temperature (20 ± 5 °C) and light-protected
- Other: stability under storage conditions: yes

Test animals

Species:
rat
Strain:
other: RccHan: WIST
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: polyethylene glycol 300 (PEG 300)
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

The acute dermal toxicity of Y-15866 was tested in accordance with OECD guideline 402 and in compliance with GLP. The study was performed as a limit test in RccHan: WIST rats (5 males and 5 females) at a dose of 2000 mg/kg bw. The test substance was applied at a concentration of 50% (w/w) in polyethylene glycol 300 (PEG 300) onto the clipped skin of the test animals for 24 h under semiocclusive conditions. After removal of the test substance, animals were observed for a period of 14 days. No local dermal signs were noted during the course of the study with the exception of one male, which showed very slight erythema at the application site on Day 2 after treatment. No mortalities and no signs of systemic toxicity were observed. The body weight evolution in all animals was not affected by treatment. No macroscopic findings were recorded at necropsy. Based on these results, the dermal LD50 value for male and female rats was greater than 2000 mg/kg bw.