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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 December, 1990 - 21 March, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
EC Number:
406-420-4
EC Name:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Cas Number:
69430-40-6
Molecular formula:
Unspecified example: C18.3H46.8O5.8Si4.1
IUPAC Name:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Details on test material:
Identification: DC 5067
Description: Clear, light brown liquid
Lot Number: AB 090122
Purity: >99%
Storage conditions: In the original container at room temperature in the dark
Stability under storage conditions: Stab1e
Expiry date: December 1, 1991

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg body weight.
5.26 ml/kg body weight.
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: 95% CL n/a

Any other information on results incl. tables

MORTALITY

No mortality occurred during the study period.

OBSERVATIONS

All animals showed lethargy and piloerection on the day of treatment only. All animals showed body weight gain over the study period.

PATHOLOGY

Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities, that were not commonly noted among rats of this age and strain.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral value of DC 5067 in rats of either sex was established as exceeding 5000 mg/kg body weight.
Executive summary:

The purpose of this study was to assess the toxicity of the test article when administered to rats as a single oral dose. The study was carried out in accordance with OECD Guideline Number 401, "Acute Oral Toxicity" and EEC Directive 84/449/EEC7 Part 8.1, "Acute Toxicity-Oral". DC5067 was administered by oral gavage, to five rats of each sex, at 5000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.

No animals died during the study. All animals showed lethargy and piloerection on the day of treatment. All animals showed body weight gain over the study period. Macrosopic post mortem examination of the surviving animals at termination did not reveal any abnormalities, that were not commonly noted among rats of this age and strain. The oral LD50 value of DC5067 in rats of either sex was established as exceeding 5000 rng/kg body weight.

According to the EEC criteria for classification and labeling requirements for dangerous substances (EEC Directive 83/467/EEC7 Annex VI of the EEC Directive 67/548/EEC), DC5067 cannot be classified and has no obligatory labelling requirement