Registration Dossier
Registration Dossier
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EC number: 241-972-8 | CAS number: 18063-03-1
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- other: Non-GLP, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,6-difluorobenzamide
- EC Number:
- 241-972-8
- EC Name:
- 2,6-difluorobenzamide
- Cas Number:
- 18063-03-1
- Molecular formula:
- C7H5F2NO
- IUPAC Name:
- 2,6-difluorobenzamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch number: 722.35
ST number: ST86/206
Characterisation: no purity data available- commercial sample
Appearance: white powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding unit
- Age at study initiation: 4 to 9 months
- Weight at study initiation: 4.8 kg (males) and 4.4 kg (females)
- Housing: single in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cgae measured 67 x 43 x 45 cm
- Diet: Standard Rabbit Diet (S.Q.C., Special Diet Service Ltd., Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg powder - Duration of treatment / exposure:
- single application, the eyes were not washed thereafter
- Observation period (in vivo):
- 1 hour, 4-7, 24, 48, 72 hours and 7 days after instillation
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable: no effects were observed
- Remarks on result:
- other: the score was also 0 at 1 hour, 4-7 hours and 7 days after installation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable: no effects were observed
- Remarks on result:
- other: the score was also 0 at 1 hour, 4-7 hours and 7 days after installation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable: no effects were observed
- Remarks on result:
- other: the score was also 0 at 1 hour, 4-7 hours and 7 days after installation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable: no effects were observed
- Remarks on result:
- other: the score was also 0 at 1 hour, 4-7 hours and 7 days after installation
- Irritant / corrosive response data:
- no ocular effects
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The instillation of the test item into the conjuctival sac of the eyes of six rabbits resulted in no initial pain and no ocular effects. The test material is therefore not an eye irritant in rabbits.
- Executive summary:
In an eye irritation test according to OECD guideline 405, 2,6-difluorobenzamide was applied as 25 mg of powder to the conjunctival sac of one of the eyes of New Zealand White rabbits (3/sex) (Sittingbourne Research Centre, 1987). The eyes were not washed thereafter. A visual assessment of the eyes was performed at 1, 4-7, 24, 48 and 72 hours and 7 days after instillation. No effects on any of the eye irritation parameters (cornea, iris, chemosis and conjunctivae score) were observed nor was there any indication of an initial pain response. The substance was judged as being not irritating to the eyes.
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