Registration Dossier
Registration Dossier
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EC number: 270-185-2 | CAS number: 68412-38-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77899.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (purity unknown, non-GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- Sicotan Braun K 2711
- Cas Number:
- 68412-38-4
- IUPAC Name:
- Sicotan Braun K 2711
- Details on test material:
- no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.89 kg (males) and 2.70 kg (females)
- Housing: 1 per cage (Stainless steel cages with wire mesh walk floors)
- Diet: Kliba 341, approx. 130 g/d
- Water: tap water, approx. 250 ml/d
- Acclimation period: at least 8 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Controls:
- other: The untreated eye served as negative control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (approx. 104 mg) - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not removed
SCORING SYSTEM: OECD/ Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- other: Slight redness was seen only 1 hr after application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- other: Slight redness was seen only 1 hr after application
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following the conditions of the test: No classification as eye irritant according to EU and GHS criteria.
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