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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 3 - February 27, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
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:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 65 min., 24 hrs, 48 hrs, 72 hrs
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Erythema also outside treated site.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 65 min., 24 hrs, 48 hrs, 72 hrs
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Oedema also outside treated site.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 65 min., 24 hrs, 48 hrs, 72 hrs
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 14 Tage
Remarks on result:
other: Ervthema also outside treated site.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 65 min., 24 hrs, 48 hrs, 72 hrs
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Ervthema and oedema also outside treated site.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 65 min., 24 hrs, 48 hrs, 72 hrs
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Ervthema and oedema also outside treated site.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 65 min., 24 hrs, 48 hrs, 72 hrs
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 65 min., 24 hrs, 48 hrs (all animals): Ervthema and oedema also outside treated site. 72 hours/animals 2 and 3: Erythemaalso outside treated side.
Other effects:
No other effects observed.

Any other information on results incl. tables

The observed skin irritation consisted of well defined erythema and very slight or slight oedema in the three animals. The skin irritation was reversible within 14 days after exposure in all animals.

No staining of the treated skin by the test substance was observed.

There was no evidence of a corrosive effect on the skin.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DC 5067 resulted in a primary irritation index of 2.3 (moderately irritating) when applied to the intact rabbit skin.
According to the EEC criteria for classification and labelling requirements for dangerous substances (EEC Directive 83/467/EEC, Annex VI of the EEC Council Directive 67/548/EEC), DC 5067 need not be labelled as a skin irritant.
Executive summary:

The purpose of this study was to assess the possible irritation or corrosion potential of DC5067 when a single dose was placed on the skin of rabbits. This study was carried out in accordance with OECD Guideline Number 404, "Acute Dermal Irri tation/Corrosion and EEC Directive 84/449/EEC, Part 8.4, "Acute Toxicity-Skin Irritation". DC5067 was applied on the shaved skin of three female rabbits using semi-occlusive dressings for 4 hours, followed by six observations at approximately 1, 24, 48 and 72 hours and 7 and 14 days after removal of the dressings and the remaining test substance. Under the conditions of this study, DC5067 resulted in well defined erythema and very slight or slight oedema in the three animals. The skin irritation was reversible within 14 days after exposure in all animals. In the area of application, no staining of the treated skin in any of the rabbits. No signs of systemic intoxication were observed during the study period.