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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-02-11 to 2008-02-22
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 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)

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

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system 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 - 5.5 months
- Weight at study initiation:
Animal no. 1: 2.4 kg
Animal no. 2: 2.4 kg
Animal no. 3: 2.2 kg
- Housing: Before and after the exposure period, the animals were kept singly in cages measuring 380 mm x 425 mm x 600 mm. During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded
irritation of the skin by excrements and urine.
- Diet: Commercial diet, ssniff® K-H V2333 served as food. The food was available ad libitum before and after the exposure period.
- Water: ad libitum

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: The surrounding untreated skin served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg test item/patch and animal
- Concentration: Aliquots of the test item were mixed at a ratio of 1:0.5 (w/w) with aqua ad iniectabilia (Batch no. 24610811), and 750 mg of this paste were applied per animal.

No further details are given.
Duration of treatment / exposure:
4-hour periods
Observation period:
At least 20 adaptation days, 1 test day and a follow-up period of 72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: The test item was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin with non-irritating tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure time no residual test item had to be removed.

SUSPECTED CORROSIVE/IRRITATING TEST ITEMS
- Initial test: As there was no evidence that the test item will produce severe irritancy or corrosion, a single patch was applied to one animal for 4 hours.
- Confirmatory test: As no corrosive or severe irritant effects were observed in the initial test, 2 further animals were employed 24 hours after start of the initial test.

SCORING SYSTEM: see attached tables

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: before dosing
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 minutes
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: before dosing
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 minutes
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Under the present test conditions, none of three rabbits exposed for 4 hours to the test substance showed any skin reactions at the examination time-points 60 minutes, 24, 48 and 72 hours after patch removal. 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 the test item revealed no skin irritating properties in rabbits.