Registration Dossier
Registration Dossier
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EC number: 275-738-1 | CAS number: 71631-15-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77504.
Toxicological information
Eye irritation
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: see 'Remark'
- Remarks:
- Comparable to guideline study reliable without restrictions Minor deviations from the guideline: - the lot/batch no. of the test substance was not stated. - the relative humidity is slightly higher than 70 % (55 % +/- 25%). - it was not stated, if the eyelids were held together after application of the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1987-02-24
- Deviations:
- yes
- Remarks:
- , please refer to "Rationale for reliability incl. deficiencies" above
- GLP compliance:
- no
Test material
- Reference substance name:
- Nickel iron chromite black spinel
- EC Number:
- 275-738-1
- EC Name:
- Nickel iron chromite black spinel
- Cas Number:
- 71631-15-7
- Molecular formula:
- (Ni,Fe)(Fe,Cr)2O4
- IUPAC Name:
- Nickel iron chromite black spinel
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): NEGRO-G19
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2072 grams - 2212 grams
- Housing: individual stainless steel cages, brand Tecniplast; cleaning: automatic
- Diet (daily dose of 150 g): special diet for experimental rabbits, provided by an authorized provider
- Drink: automatic ad libitum, treated and filtered at 5 µm
- Acclimation period: 7 days
At arrival at the Unit, rabbits went through a health control.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 2 °C
- Relative humidity: 55 % +/- 25 %
- Air: renewed 15 times per hour and prefiltered at 5 µm
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the solid test item (grinded to fine dust) was administered into the conjunctival bag of one eye by separating the lower eyelid.The untreated eye was used as control. - Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 7 days after administration of the test substance
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- The rabbits were fixed in an immobilization trap during test item administration.
REMOVAL OF TEST SUBSTANCE
not stated
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: in order to facilitate the evaluation of the reactions, light from a manual lamp was used and 24 hours after administration of the test item, fluorescein was used to check for injuries of the cornea.
OBSERVATIONS:
- Weight control: it was performed at the beginning of the study
- General examination: the general condition of the animal was observed, as well as the conditions of the eyes. Special attention was given to the apparition of modifications on the treated eye: cornea, iris, conjunctiva, as well as any other injury observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 adn 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Opacity of the cornea of grade 1 affecting 1/4 of the eyeball was observed in two animals at the 1 hour and 24 hour observations. Opacity of the cornea of grade 1 was also observed in the remaining animal at the 1 hour observation.
Injury of the iris of grade 1 was observed in two animals at the 1 hour observation. Injury of the iris of grade 1 was also observed in the remaining animal at the 1 hour and 24 hour observation.
Erythema of the conjunctiva of grade 2 was observed in all animals at the 1 hour, 24 hour and 48 hour observations. The erythema of the conjunctiva changed to a grade 1 in all animals at the 72 hour observation and had disappeared by day 7.
Oedema of the conjunctiva of grade 1 was observed in one animal at the 1 hour, 24 hour and 48 hour observations and in another animal at the 1 hour and 48 hour observation. Oedema of the conjunctiva of grade 2 was observed in the remaining animal at the 1 hour observation , which changed to a grade 1 at the 24 hour observation and had disappeared at the 48 hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- NEGRO-G19 is not irritating to the eye.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
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