Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-28 to 2009-05-13
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).
EC Number:
700-534-0
Cas Number:
117172-56-2
Molecular formula:
Not applicable: UVCB substance, see section 1.2 and 1.4. The UVCB substance consits of differnt products consiting of differnt isomers: Product I and Product II cannot analytically be distinguished and moreover, Product I-III are expected to consist of isomers that can neither analytically be identified nor quantified.
IUPAC Name:
Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).
Constituent 2
Reference substance name:
Reaction products of 3- (trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1)
IUPAC Name:
Reaction products of 3- (trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1)
Details on test material:
- Name of test material: Intermediate 36
- Colour: light yellow
- Physical state: liquid
- Purity: >99%

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
Based on density of the test item (= 1.058 g/cm3), the dose volume was 1.89 mL/kg bw at the temperature 22±3 C˚.
No. of animals per sex per dose:
3
Control animals:
not specified

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of the present study, a single oral administration of the test item Intermediate 36 at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects. According to OECD Guideline No. 423, Intermediate 36 was ranked into ‘Category 5 or Unclassified’ (at least GHS Category 5) in terms of Globally Harmonized Classification System as described in this guideline.
Executive summary:

In summary, a single oral gavage treatment with Intermediate 36 did not cause any test article related adverse effects, all findings were typical for rats following euthanasia and exsanguination.
The acute toxic class method according to Comission Regulation (EC) No 440/2008, Annex Part B, B.1.tris: " Acute Oral Toxicity – Acute Toxic Class Method", Official Journal of the European Union No. L 142, dated May 31st, 2008. and First Addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 423, “Acute Oral Toxicity – Acute Toxic Class Method.”, adopted 17th December 2001, was performed with Intermediate 36 in rats. The study was performed at a dose level of 2000 mg/kg bw. Two groups of three female CRL: (WI) BR Wistar rats were treated with Intermediate 36 at 2000 mg/kg bw (Groups 1 and 2). Initially, three females (Group 1) were treated at 2000 mg/kg bw. As no mortality occurred in this dose group, a confirmatory treatment according to OECD 423 was performed on 3 further females at the same dose level (2000 mg/kg bw). As no mortality was observed in the second dose group, no further treatment was needed. A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Intermediate 36 was administered undiluted as supplied by the Sponsor. Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Food was made available again 3 hours after the treatment. Body weight was measured on Days -1, 0 and 7 and before necropsy. Gross necropsy was performed on all animals (Day 14). The day of dosing was designated as Day 0.
A single oral gavage of Intermediate 36 to the CRL: (WI) BR Wistar rat at a dose level of 2000 mg/kg bw, followed by a 14-day observation period did not produce any test item-related macroscopic findings.