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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 7 - March 19, 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 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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:
- Name of test material (as cited in study report): DC 5067
- Substance type: Reaction mass (mixture)
- Physical state: Liquid
- Analytical purity: > 99%
- Lot/batch No.: AB 090122
- Expiration date of the lot/batch: December 1, 1991
- Stability under test conditions: Stable
- Storage condition of test material: In the original container at room temperature in the dark
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
The test substance (0.1 ml per animal) was instilled in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
Number of animals or in vitro replicates:
3 (females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Draize score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hrs
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: No occular corrosion, no signs of systemic intoxication
Irritation parameter:
overall irritation score
Remarks:
Draize score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hrs
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: No occular corrosion, no signs of systemic intoxication
Irritation parameter:
overall irritation score
Remarks:
Draize score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hrs
Score:
>= 0 - <= 6
Max. score:
6
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: No occular corrosion, no signs of systemic intoxication
Other effects:
No other effects observed.

Any other information on results incl. tables

Irritation:

Instillation of DC 5067 into one of the eyes of each of three albino rabbits affected the conjunctivae of all animals. The irritation of the conjunctivae was reversible within 48 hours in all animals. Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no cornea1 epithelial damage in all of the animals.

Colouration:

No staining by the test substance was observed.

Corrosion:

There was no evidence of ocular corrosion.

Toxic Symptoms / Mortality:

No toxic symptoms were observed in the animals during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Draize score: 3.3, Kay and Calandra rating: M1 Criteria used for interpretation of results: other: Draize score (Draize et al., J. Pharmacol. Exp. Ther. 82, 1944)
Conclusions:
DC 5067 should be considered minimally irritating (Ml) to the rabbit eye (Kay and Calandra interpretation of the Draize score : 3.3).
Executive summary:

The purpose of this study was to assess the possible irritation or corrosion potential of DC5067 when a single dose of DC5067 was placed in the conjunctival sac of a rabbit eye.

This study was carried out in accordance with OECD Guideline Number 405, "Acute Eye Irrittion/Corrosion" and EEC Directive 84/449/EEC, Part B.5, "Acute Toxicity-Eye Irritation". DC5067 was instilled in one of the eyes of each of three female rabbits, followed by four observations at approximately 1, 24, 48, and 72 hours after test article administration.

Under the conditions of this study, DC5067 resulted in adverse effects of the conjunctivae in all three animals. The irritation of the conjunctivae was reversible within 48 hours in all animals. No ocular corrosion was observed in any of the animals. No signs of systemic intoxication were observed during the study period.

The test substance should be considered minimally irritating (Ml) to the rabbit eye (Kay and Calandra interpretation of the Draize score: 3.3).

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 67/54B/EEC, DC5067 need not be labelled as an eye irritant.