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Toxicological information

Eye irritation

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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:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.