Registration Dossier

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:
1990-07-16 to 1990-07-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, conducted and documented in accordance with GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 February 1987
Deviations:
no
GLP compliance:
yes
Remarks:
The study report states that the study was conducted in compliance with Good Laboratory Practice Standards, e.g. by the United Kingdom Compliance Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health, 1989.

Test material

Constituent 1
Reference substance name:
Molybdenum trioxide
EC Number:
215-204-7
EC Name:
Molybdenum trioxide
Cas Number:
1313-27-5
IUPAC Name:
trioxomolybdenum
Details on test material:
- Name of test material (as cited in study report): Pure molybdic oxide
- Physical state: light grey powder
- Analytical purity: > 99.9% (calculated based on molybdenum content of 66.63 %)
- Impurities (identity and concentrations): no relevant impurities were stated (> 1.0%)
- Purity test date: 1990-06-06
- Stability under test conditions: not determined
- Storage condition of test material: at ambient temperature

No further significant information on test material was stated.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: aprroximately 11 to 13 weeks
- Weight at study initiation: weight range 2.6 to 3.0 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: free access to SDS Standard Rabbit Diet
- Water: free access to tap water
- Acclimation period: the rabbits were acclimated, but the acclimatisation period is not stated


ENVIRONMENTAL CONDITIONS
- Temperature: maintained at approximately 19 °C
- Relative humidity: maintained at 30-70%
- Air exchanges: maintained at approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hr / 12 hr

No further significant details on test animals were stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: A 100 mg amount of Pure molybdic oxide, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.

VEHICLE: Test substance was administered as supplied by the Sponsor.

No further significant information on Amount/concentration applied was stated.
Duration of treatment / exposure:
not stated
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.
Number of animals or in vitro replicates:
6 males
Details on study design:
SCORING SYSTEM:

Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows:

Cornea:
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible = 1
Easily discernible translucent areas, details of iris slightly obscured = 2
Nacrous areas, no details of iris visible, size of pupil barely discernible = 3
Opaque cornea, iris not discernible through the opacity = 4



Area of cornea involved:
One quarter (or less) but not zero = 1
Greater than one quarter, but less than half = 2
Greater than half, but less than three quarters = 3
Greater than three quarters, up to whole area = 4

Iris:
Normal = 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) = 1
No reaction to light, haemorrhage, gross destruction (any or all of these) = 2

Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
Blood vessels normal = 0
Some blood vessels definitely hyperaemic (injected) = 1
Diffuse, crimson colour, individual vessels not easily discernible = 2
Diffuse, beefy red = 3

Chemosis (lids and/or nictitating membranes)
No swelling = 0
Any swelling above normal (includes nictitating membranes) = 1
Obvious swelling with partial eversion of lids = 2
Swelling with lids about half-closed = 3
Swelling with lids more than half-closed = 4

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld torch.

OTHER OBSERVATIONS: All animals were observed daily for signs of ill health or toxic signs.

No further significant information was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean for all 6 animals
Time point:
other: 24, 48 and 72h
Score:
0
Irritation parameter:
iris score
Basis:
other: mean for all 6 animals
Time point:
other: 24, 48 and 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
mean
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of molybdic trioxide into the rabbit eye elicited transient mild conjunctival inflammation only.
Molybdenum trioxide does not require classification as an eye irritant according to directive 67/548/EEC or regulation 1272/2008/EC, respectively. A pdf document including the calculation of mean irritation scores according to both guidelines is attached to this endpoint study record.