Registration Dossier
Registration Dossier
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EC number: 603-450-1 | CAS number: 1310-39-0
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-09-14 to 2016-10-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012-10-02
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2014-05-14
Test material
- Reference substance name:
- Iron titanium pseudobrookite
- EC Number:
- 603-450-1
- Cas Number:
- 1310-39-0
- Molecular formula:
- FexTiOy 1.2 ≤ x ≤ 2.1 y = 3/2 x + 2
- IUPAC Name:
- Iron titanium pseudobrookite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Pseudobrookite; Pigment Brown 48
- Physical state: brown powder, odourless
- Density: 4.25 g/cm³
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, stored in closed original container in a dry place
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Age at dosing: approx. 7 months
- Weight at dosing: 4.4 kg to 6.1 kg
- Housing: kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany)
- Diet (ad libitum): commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% - 70% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test material - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the administration
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- INITIAL AND CONFIRMATORY TEST
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in the animal treated in the preliminary test, 2 further animals were employed 24 hours after start of the initial test.
USAGE OF ANAESTHETICS AND SYSTEMIC ANALGESICS
Sixty minutes prior to test item administration, 0.01 mg Buprenovet®/kg bw were administered by subcutaneous (s.c.) injection to all animals to provide a therapeutic level of systemic analgesia to avoid or minimize pain and distress.
Five minutes prior to the test item administration, two drops of Conjuncain®EDO, a topical anaesthetic, were applied to each eye of all animals, to the right eye, in which the test item was to be applied, and to the left eye, which served as control.
Seven hours after administration, Buprenovet® 0.01 mg/kg, s.c. and Acticam 0.5 mg/kg, s.c. were administered to provide a continued therapeutic level of systemic analgesia.
REMOVAL OF TEST SUBSTANCE
- Washing: eyes were rinsed with 20 mL 0.9 % aqueous NaCl solution
- Time after start of exposure: 1 hour
SCORING SYSTEM: according to the Draize scale and a scale scoring the degree of staining (Fluorescein-test)
TOOL USED TO ASSESS SCORE: slit lamp and 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.
24, 48 and 72 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
OBSERVATIONS
- body weight: at the beginning and at the end of the study.
- behaviour and food consumption were monitored
- any adverse systemic effects were recorded
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - slight conjunctival redness (grade 1) and slight chemosis (grade 1) were observed in all animals 1 hour after administration.
- corneae and the irises were not affected by administration of the test item. - Other effects:
- - Lesions and clinical observations: no systemic intolerance reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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