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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, which is well documented and scientifically acceptable
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Bayeferrox VP AC 5122 M: Fe2O3 83.5 %, FeO 12%, Co 4.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Male rabbits were kept under standardised conditions in individual cages at a temperature between 19 and 15oC and a relative humidity between 40 and 60%. The animals weighed between 3 and 4 kg. The day/night rhytm was 12/12 hrs. The animals were fed with a standard diet and were allowed to drink tap water ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye was treated, one eye served as a control.
Amount / concentration applied:
100 mg fine powdered
Duration of treatment / exposure:
168 hours

Observation period (in vivo):
analog duration of treatment

Number of animals or in vitro replicates:
3
Details on study design:
Every animal was treated with 100 mg of fine powdered sample in the conjunctival sac of the eye. After application the eye was kept close for 1 second. After 24 hrs the treated eye was rinsed with a physiological salt solution. The other eye was not treated and served as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, 48, 72 and 168 hrs
Score:
0
Max. score:
0
Remarks on result:
other: no effect findings at any time point for any animal
Irritation parameter:
iris score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, 48, 72 and 168 hrs
Score:
0
Max. score:
0
Remarks on result:
other: no effect was observed at any point in time for any animal
Irritation parameter:
conjunctivae score
Basis:
other: each animal was evaluated individually
Time point:
other: 1, 24, 48, 72 and 168 hrs
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
other: One animal scored 1 in redness at 24 hrs. All other scores at all timepoints were 0.
Irritant / corrosive response data:
not irritating
Other effects:
No exsessive tear formation or any other adverse effects were observed for any animal at any point in time (each animal was evaluated seperately at 1, 24, 48, 72 and 168 h).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

In an eye irritation study, 100 mg of Bayeferrox VP AC 5122 M (a mixture consisting of Fe2O3 83.5 %, FeO 12%, Co 4.5%) was instilled into the conjunctival sac of the eye of 3 rabbits, according to OECD guideline 405. Animals were observed for a total of 168 hrs.  This study showed that Bayeferrox VP AC 5122 M is not eye irritating.