Registration Dossier
Registration Dossier
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EC number: 231-891-6 | CAS number: 7775-19-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 12179-04-3
- Cas Number:
- 12179-04-3
- IUPAC Name:
- 12179-04-3
- Details on test material:
- - Name of test material: Borax 5 Mol: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: OE26
- Stability under test conditions: Stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harvey’s Lake, PA.
- Weight at study initiation: 2.4 – 2.8 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.08 mL equivalent.
- Duration of treatment / exposure:
- 14 days.
- Observation period (in vivo):
- 14 days.
- Number of animals or in vitro replicates:
- Six.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No rinsing was done.
SCORING SYSTEM: Scoring in report according to Draize, but scoring reported here according to EU 67/548/EEC.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
Any other information on results incl. tables
Results:
|
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
|||
score (average of animals investigated) |
0 to 4 |
0 to 2 |
0 to 3 |
0 to4 |
60 min |
0.00 |
0.00 |
2.33 |
3.00 |
24 h |
0.00 |
0.67 |
3.00 |
2.00 |
48 h |
0.00 |
0.00 |
3.00 |
2.00 |
72 h |
0.67 |
0.00 |
2.33 |
1.67 |
Average 24h, 48h, 72h |
0.22 |
0.22 |
2.80 |
1.89 |
Maximum average score (including area affected, max 110) |
|
|
|
|
Reversibility |
yes |
yes |
yes |
yes |
average time for reversion |
By Day 14 |
By Day 14 |
By Day 14 |
By Day 14 |
This study was carried out at the request of the US EPA to confirm that the eye irritation previously seen with disodium tetraborate pentahydrate was caused by the glassy nature of the crystals of substance and not a chemical effect of irritation, the sample in this study was ground to a fine powder before instillation to reduce the glassy, sharp crystals in the sample.
In normal handling and use the large glassy crystals would not be able to enter the eye easily and in addition over 50 years of occupational exposure to disodium tetraborate pentahydrate as well as other borates have indicated no adverse effects on the human eye.
As a result for this study the US EPA accepted that the effects were mechanical downgraded its classification according to US FIFRA to Toxicity II (40 CFR 156) by ocular administration (Corneal involvement or irritation clearing in 8-21 days).
The substance is not classifiable in the EU under Regulation (EC) No 12727/2008.
Disodium tetraborate decahydrate is used as a buffer in eyewashes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the mean redness score >2, the substance is classified as irritant to the eyes.
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