Registration Dossier
Registration Dossier
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EC number: 236-337-7 | CAS number: 13308-51-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Jul - 01 Aug 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2012)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Boron orthophosphate
- EC Number:
- 236-337-7
- EC Name:
- Boron orthophosphate
- Cas Number:
- 13308-51-5
- Molecular formula:
- BPO4
- IUPAC Name:
- boron(+3) cation phosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino (Zika)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kaninchenbetrieb Kock, Warnkenhagen, Germany
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: 2980 and 3210 g
- Housing: the test animals were housed individually in cages.
- Diet: conventional laboratory diet (a half-and-half blend of "Holstenstolz Kaninchenverbrauchsfutter 2, Type 038" [Wilhelm Stroeh jr. GmbH & Co. KG, Germany] and "Rabbit maintenance, MuesliMash", [ssniff Spezialdiäten GmbH, Germany], ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 8 days
Reading time points: 1, 24, 48 and 72 h and 8 days - Number of animals or in vitro replicates:
- 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The solid test substance had not been removed from the eye of the test animals by physiological mechanisms at the first observation time point after treatment, therefore the eyes were rinsed with physiological saline.
- Time after start of exposure: 1h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight conjunctival redness and chemosis (grade 1) were observed in 2/2 animals 1 h post-application of the test material, which were fully reversible within 24 h. No effects on cornea and iris were recorded. One animal was further observed for up to 8 days, which showed no effects in the treated eye.
- Other effects:
- No further local or systemic effects and no effects on body weight gain were observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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