Tin, dioctylbis(2,4-pentanedionato-.kappa.O2,.kappa.O4)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

july to august 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel Des Produits Chimiques, Paris, France

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

483-270-6

EC Name:

-

Cas Number:

54068-28-9

Molecular formula:

Hill formula: C26H48O4Sn CAS formula: C26H48O4Sn

IUPAC Name:

(3Z)-4-{[dioctyl({[(2Z)-4-oxopent-2-en-2-yl]oxy})stannyl]oxy}pent-3-en-2-one

Details on test material:

VP07-560

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

-

Duration of treatment / exposure:

weight: 2.79 - 3.03 kg
temperature: 19 - 24°C
relative humidity: 43 -66 %
lighting time: 12 hours daily
rate of air exchange: at least ten changes per hour

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

-

Results and discussion

In vitro

Results

Irritation parameter:

other: -

Run / experiment:

-

Value:

> 0.2 - < 1

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

not measured/tested

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

0.8

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Other effects:

It was noted a whitish secretion, requiring a physiological saline rinse, in one animal at D1.

Any other information on results incl. tables

see study report

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EU, OECD GHS

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item TIB
KAT 223:
- is slightly irritant for the eye (Max. O.I = 8.0) according to the classification established in the
Journal Officiel de la République Française dated July 10th, 1992.
- and, must not be classified according to the criteria for the classification, packaging and labelling of
dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No
symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not
be classified in category 2. No signal word and hazard statement are required.

Executive summary:

see study report