α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

2,2,4,4,6,12,15-heptamethyl-6-[(trimethylsilyl)oxy]-3,5,10,13,16-pentaoxa-2,4,6-trisilaheptadecane

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