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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

july to august 2008

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel Des Produits Chimiques, Paris, France

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

weight: 2.41 - 3.00 kg
temperature: 19 - 24°C
relative humidity: 43 -66 %
lighting time: 12 hours daily
rate of air exchange: at least ten changes per hour

Type of coverage:

other: patch, secured with surgical adhesive tape

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all

Time point:

other: 1 hour

Score:

> 0 - < 1

Reversibility:

fully reversible

Remarks on result:

other: between D2 and D4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

> 0 - < 1

Reversibility:

fully reversible

Remarks on result:

other: between D1 and D3

Other effects:

On the cutaneous structure. a slight dryness was noted on the treated area, from D3 in three animals. The skin recovered a normal
aspect between D8 and D10.

see study report

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, according to the scales of interpretation retained:
- is irritant to skin (PSi = 2.3) according to the classification established in the Journal Officiel de la
République Française dated February 21st, 1982,
- and, must not be classified, according to the criteria for classification, packaging and labelling of
dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59
and 99/45. No symbol and risk phrases are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not
be classified in category 2 “Irritant”. No signal word and hazard statement are required.

Executive summary:

see study report

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

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

Species:

rabbit

Strain:

New Zealand White

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:

-

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

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

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

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

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.

see study report

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available