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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 26, 1988 - March 13, 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
Dose level: 2000 mg/kg b.w.
Dose volume: 2.11 ml/kg b.w.
No. of animals per sex per dose:
5 males, 5 females
Control animals:
not required

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: confidence limits n/a

Any other information on results incl. tables

MORTALITY

No mortality occurred during the study period.

OBSERVATIONS

NO clinical signs of ill health or behavioural changes were seen during the study.

All animals showed body weight gain over the study period.

TREATED SKIN ABNORMALITIES

No skin irritation was observed on the treated area during 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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of DC 5067 in rats of either sex was established as exceeding 2000 mg/kg body weight.
Executive summary:

This study was entitled "Assessment of acute dermal toxicity with DC 5067 in the rat". The purpose of this study was to assess the toxicity of the test article when administered to rats as a single dermal dose. The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity" and EEC Directive 84/449/EEC, Part 8.3, "Acute Toxicity - Dermal".

DC 5067 was administered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.

No clinical signs of ill health or behavioural changes were seen during the study. All animals showed body weight gain over the study period. No skin abnormalities were observed on the treated area during the study period. 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.

The dermal LD50 value of DC 5067 in rats of either sex was established as exceeding 2000 mg/kg body weight.

According to the EEC criteria for classification and labelling requirements for dangerous substances'(EEC Directive 83/467/EEC, Annex VI of the EEC Directive