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EC number: 244-870-1 | CAS number: 22252-43-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 dagen
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the study was old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- not under GLP conditions (studies dates 1983)
- Principles of method if other than guideline:
- Six animals are dived per two and were treated as follows:
Group 1- the test substance is added and not rinsed.
Group 2- the test substance is rinsed after 4 seconds with 0.5% alcohol.
Group 3- the test substance is rinsed after 8 seconds with 0.5% alcohol.
In all treated animals the other eye serves as negative control. Irritation is scored after 24, 48, 72 hours, and after 4 and 7 days conform Draize. - GLP compliance:
- not specified
Test material
- Reference substance name:
- (6R-trans)-7-amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- EC Number:
- 244-870-1
- EC Name:
- (6R-trans)-7-amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Cas Number:
- 22252-43-3
- Molecular formula:
- C8H10N2O3S
- IUPAC Name:
- 7-amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Reference substance name:
- 7-aminodesacetoxycephalosporanic acid
- IUPAC Name:
- 7-aminodesacetoxycephalosporanic acid
- Details on test material:
- -Name of test material (as cited in study report): ZOR-F
- Substance type: white to off-white powder
- Physical state: solid
- Analytical purity: 98.6 %
- Impurities (identity and concentrations): no impurities -> 1%
- Purity test date: not mentioned
- Lot/batch No.: 28055
- Expiration date of the lot/batch: not mentioned
- Storage: ambient temperature
- Other: a Certificate of Analysis of batch 28055 is included in the report
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman te Someren
- Age at study initiation: not mentioned
- Weight at study initiation: 2,2 - 3,2 kg
- Housing: not mentiond
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not mentioned
ENVIRONMENTAL CONDITIONS: not mentioned
Test system
- Vehicle:
- not specified
- Controls:
- other: other eye served as negative control
- Amount / concentration applied:
- TEST MATERIAL: not mentioned
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 g - Duration of treatment / exposure:
- Rinsed after 4 and 8 seconds, or not rinsed.
- Observation period (in vivo):
- 24, 48, 72 hours, and 4 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 and 8 seconds, or not
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4, 7 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4, 7 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Time point:
- other: 1, 2, 3 ,4, 7 days
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- not irritant, not corrosive
- Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- A study in 6 rabbits revealed that ZOR-F was not irritating for the eye. The study was not performed under GLP conditions, but the used method was comparable to OECD Guideline 405.
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