Registration Dossier
Registration Dossier
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EC number: 268-608-0 | CAS number: 68131-04-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from August 21, 2007 to September 10, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- short term temperature change
- Principles of method if other than guideline:
- Increasing of temperature of animals room (up to 26.1°C). The limit (in EU Method B.4) for temperature is 20 ± 3°C. The deviation from the limit was short-term and did not influence the wellness of animals and the study results.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Humic acids, sodium salts
- EC Number:
- 268-608-0
- EC Name:
- Humic acids, sodium salts
- Cas Number:
- 68131-04-4
- Molecular formula:
- NA
- IUPAC Name:
- Humic acids, sodium salts
- Details on test material:
- - Name of test material (as cited in study report): Humic acids, sodium salts
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 9. 5. 2007/R
- Expiration date of the lot/batch: 05/2022
- Stability under test conditions: stable
- Storage condition of test material: dry conditions
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeding farm BioTest s.r.o., Konárovice, 281 25, Czech Republic
- Age: 4-5 months
- Weight at study initiation: 3.4-3.9 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 17 - 23ºC, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3 (1male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: water irrigation
- Time after start of exposure: 24 hours
SCORING SYSTEM:
The grades of ocular reaction (conjunctivae, cornea and iris) -see Table
TOOL USED TO ASSESS SCORE: fluorescein, ophthalmoscopy
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: some blood vessels hyperaemic (injected)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48,72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: some swelling above normal
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1, 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: some blood vessels hyperaemic (injected)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: some swelling above normal
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1, 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: some blood vessels hyperaemic (injected)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: some swelling above normal
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corrosive response data
- Other effects:
- No clinical signs of systemic intoxication
No mortality
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test substance was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the EU Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Directive 2004/73/EC. Published in O.J. L 152, 2004.
The test was performed initially using one animal. Because corrosive effect was not observed in initial test, negative response was confirmed using two additional animals.
The following changes were observed on eye of animals at 1 hour after application in all animals: conjunctivae - some blood vessels hyperaemic (injected) and some swelling above normal. At 24 hours after application changes were observed in all animals: conjunctivae - some blood vessels hyperaemic (injected). At 48, 72 hours after application no other signs of eye irritation were observed.
No clinical signs of systemic intoxication were detected
Examination of eye irritation after single application demonstrated, that the test substance, Humic acids, sodium salts, is not irritating for eye of rabbit.
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