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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:
2003-06-23 to 2003-07-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented, scientifically sound study that was conducted in accordance to GLP and OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tungsten oxide blue
- Molecular formula (if other than submission substance): WO
- Physical state: Blue to black powder
- Analytical purity: 99.9%
- Purity test date: 2003-04-15
- Stability under test conditions: 5 years
- Storage condition of test material: Ambient temperature
- Other: Solubility in water- 118 mg/L at 20 degrees C
- pH: 6.9

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Weight at study initiation: 2.1-2.6 kg
- Housing: Housed singly in metal wire cages (79 cm x 59 cm bottom area, 38 cm height)
- Diet: ad libitum (Altromin 2123 maintenance diet
- Water: ad libitum (tap water from an automatic water system)
- Acclimation period: 5 days (one animal), 12 days (two other animals)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.4 degrees C
- Humidity (%): Average of 67.1%
- Photoperiod (hrs dark / hrs light): 12 dark/12 light; only artificial light from 6 am to 6 pm.

IN-LIFE DATES: From: 2003-06-23 To: 2003-07-04

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eyes remained untreated and served as control
Amount / concentration applied:
100 mg of the test substance was instilled into the conjunctival sac of the right eye of each of three rabbits. The eyes were held closed for about one second to prevent a loss of test substance.
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM
Scoring scheme for ocular lesions- Draize, examined the cornea, iris, and conjunctivae

TOOL USED TO ASSESS SCORE: Otoscope lamp

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: 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: 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: 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: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Both the untreated eyes and the eyes treated with the test substance, for all three animals, were normal at each observation point.
Other effects:
No general toxic effects of the test substance were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The administration of 100 mg of the test substance to the eyes of three female rabbits resulted in no signs of eye irritation. No general toxic effects of the test substance were observed.