Registration Dossier
Registration Dossier
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EC number: 615-229-7 | CAS number: 70969-57-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- lack of data on test substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of data on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- 189200-42-8
- Cas Number:
- 189200-42-8
- IUPAC Name:
- 189200-42-8
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HRP Inc., Denver, PA, USA
- Age at study initiation: 12 - 13 weeks (female), 16 - 17 weeks (males)
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: animals were housed separately in suspended stainless steel and wire mesh cages with absorbent paper below the cages.
- Diet: Purina Certified Diet 5322 (PMI Feeds Inc., Richmond, IN, USA), the amount of feed was limited on a not further specified daily basis
- Water: tap water, ad libitum
- Acclimation period: 15 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 29 Aug 1995
To: 05 Sep 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 d
reading timepoints: 1, 24, 48 and 72 h and 7 d - Number of animals or in vitro replicates:
- 5 males and 1 female
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% sodium fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- One hour after instillation of the test substance, slight conjunctivae redness and chemosis were observed in all animals. After 24 h and 48 h, slight conjunctivae redness was observed in 3 animals. At the 72 h reading timepoint, slight conjunctivae redness was observed in 2 animals. The effect was reversible in all animals within 7 days. The test substance did not affect the other irritation parameters in any animal at any timepoint.
Flurescein staining of the cornea was observed in three animals at the 48 h reading timepoint. At the 72 h reading, no staining of the cornea was observed indicating that the corneal response was superficial and transient. - Other effects:
- There were no clinical signs observed in any animal during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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