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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19th December 2005-17th January 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(isobutyrato)zirconium
EC Number:
619-635-5
Cas Number:
12567-73-6
Molecular formula:
Hill formula: C16H28O8Zr CAS formula: C16H28O8Zr
IUPAC Name:
Tetrakis(isobutyrato)zirconium
Constituent 2
Reference substance name:
Zirconium, tetrakis(isobutyrato)- (8CI)
IUPAC Name:
Zirconium, tetrakis(isobutyrato)- (8CI)
Details on test material:
- Name of test material (as cited in study report): Zirkonium-tetrakis(isobutyrato)
- Physical state: solid
- Analytical purity: 97.4 % (complexometric titration)
- Impurities (identity and concentrations): By-products:
toluene: ca. 2.1 %.
iso-butyric acid: ca. 0.5 %.
- Lot/batch No.: 02/05 (HK1005)
- Expiration date of the lot/batch: September 2006
- Storage condition of test material: Ambient temperature. Tightly closed. Storage under a nitrogen atmosphere, as the substance reacts with water.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Weight at study initiation: 1.9-2.2 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
- Diet (e.g. ad libitum): Altromin 2123 ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.0 °C
- Humidity (%): Average of 49.5 %, Average of 47.7 %
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The approximate equivalent of 0.1 mL of the test substance (54, 60 and 60 mg of the test substance)
Observation period (in vivo):
Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a.
An additional examination was performed in 1/3 animals 7 d p.a.
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM:

Scoring scheme for eye lesions (Grades for ocular lesions):
CORNEA:
Opacity : degree of density (area most dense is taken for reading).
0 No ulceration or opacity.
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre),
details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS:
0 Normal.
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia
or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).
CONJUNCTIVAE:
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No swelling.
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 24-72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24-72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: nº 41
Time point:
other: mean 24-72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: nº42
Time point:
other: mean 24-72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: nº 43
Time point:
other: mean 24-72 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: nº 41
Time point:
other: mean 24-72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: nº 42
Time point:
other: mean 24-72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal: nº 43
Time point:
other: mean 24-72 h
Score:
0
Irritant / corrosive response data:
The untreated eyes ("control eyes") were normal at each observation time. The eyes, treated with the test substance ("test eyes") were normal before the instillation. After the instillation of the test substance, the following findings were made:
Corneae: Not affected.
Irises: Not affected.
Conjunctivae, redness: A score of "1" in all animals from 1 h or 24 h p.a. onwards until a maximum of 72 h p.a.
Conjunctivae, chemosis: A score of "1" in all animals from 1 h onwards until a maximum of 24 h p.a.
Additional findings: Ocular discharge was noted in 1/3 animals only 1 h p.a.

Any other information on results incl. tables

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
After the instillation of the test substance, the following findings were made:
Corneae: Not affected.
Irises: Not affected.
Conjunctivae, redness: A score of "1" in all animals from 1 h or 24 h p.a. onwards until a maximum of 72 h p.a.
Conjunctivae, chemosis: A score of "1" in all animals from 1 h onwards until a maximum of 24 h p.a.
Additional findings: Ocular discharge was noted in 1/3 animals only 1 h p.a.
Ocular lesions were reversible in all animals within 7 d p.a.
Executive summary:

In vivo eye irritation: key study in rabbits, according to OECD Guideline 405 and the Directive 2004/73/EC, method B.5

The aim of this study was to investigate possible irritating or corrosive effects of the pure test substance following a single administration into a conjunctival sac of rabbits.

The approximate equivalent of 0.1 mL of Zirkonium-tetrakis(isobutyrato) was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. Firstly the test substance was administered to one animal.

Eye examinations were carried out at 1, 24, 48, 72 h and 7 d after the administration (p.a.) of the test substance (ending individually, when the animal was free of alterations).

After the instillation of the test substance, the following findings were made:

Corneae: Not affected.

Irises: Not affected.

Conjunctivae, redness: A score of "1" in all animals from 1 h or 24 h p.a. onwards until a maximum of 72 h p.a.

Conjunctivae, chemosis: A score of "1" in all animals from 1 h onwards until a maximum of 24 h p.a.

Additional findings: Ocular discharge was noted in 1/3 animals only 1 h p.a.

Ocular lesions were reversible in all animals within 7 d p.a.

The substance is classified as not irritating for eyes.