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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-02-11 to 2008-02-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Slags, ilmenite electrothermal smelting
EC Number:
293-671-6
EC Name:
Slags, ilmenite electrothermal smelting
Cas Number:
91081-64-0
Molecular formula:
M3O5
IUPAC Name:
Slags, ilmenite electrothermal smelting
Details on test material:
- Name of test material (as cited in study report): Titanium Slag "Exxaro Sulphate Slag"
- Substance type: technical product
- Physical state: solid, black brown granular
- Composition of test material, percentage of components: 100 % UGI
- Purity test date: 14 December 2006
- Lot/batch No.: MKT_SUL_061207_0000
-Receipt no. 38606
- Date of receipt December 19, 2007
- Expiration date of the lot/batch: December 2026
- Storage condition of test material: at room temperature
No further details are given.

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, Germany
- Age at study initiation: approximately 4.5 months
- Weight at study initiation:
Animal no. 1: 2.1 kg
Animal no. 2: 2.1 kg
Animal no. 3: 2.4 kg
- Housing: For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine. During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm.
- Diet: Commercial diet, ssniff7 K-H V2333 served as food. The food was available ad libitum.
- Water: ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod: 12 hours dark/light cycle
No further details are given.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye, which remained untreated, served as a control.
Amount / concentration applied:
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Single instillation into the conjunctival sac. 100 mg of the test item were administered into one eye each of three animals.
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
At least 20 adaptation days, 1 test day and a follow-up period of 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 1 hour after administration the eyes were rinsed with portions of 20 mL 0.9% aqueous NaCl solution, each.

SCORING SYSTEM: see attached list

TOOL USED TO ASSESS SCORE: fluorescein: The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: before dosing
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
iris score
Basis:
mean
Time point:
other: before dosing
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: before dosing
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: before dosing
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritation parameter:
conjunctivae score
Remarks:
secretion
Basis:
mean
Time point:
other: 60 minutes
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: examination of the treated eye
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: examination of the treated eye
Irritant / corrosive response data:
Under the present test conditions, a single instillation of 100 mg of test substance per animal into the conjunctival sac of the right eye of three rabbits caused the following changes: Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation. In addition, secretion was observed in all animals 1 hour after instillation. The corneae and the irises were not affected by instillation of the test item. The fluorescein test performed 24 hours after instillation did not reveal any changes. There were no systemic intolerance reactions.
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the present test conditions UGI revealed no eye irritating properties in rabbits.