Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 941-188-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.5
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 75782-87-5
- EC Number:
- 616-261-4
- Cas Number:
- 75782-87-5
- IUPAC Name:
- 75782-87-5
- Details on test material:
- Tradename Alchem 145 C14-16 alcohols Type A
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: direct observation and UV lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.11
- Max. score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.7
- Max. score:
- 1
- Irritant / corrosive response data:
- AVERAGE SCORE (24+48+72 hour)
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): Individual scores 5 rabbits 0, 1 rabbit 0.7 (group mean score (0.11)
- Conjunctivae (Chemosis): Individual scores 0, 1, 1, 1, 0.7, 0.7 (group mean score 0.7)
DESCRIPTION OF LESIONS: Conjunctival redness (mostly grade 1, 1 animal grade 2) was observed in all eyes and chemosis in 5/6 (one grade 2, 4 grade 1) eyes 1 hour after instillation.
REVERSIBILITY: All eyes scored 0 by day 7. Chemosis persisted in 3 animals to 72 hours. - Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Alchem 145 is not an eye irritant when classified using EU or GHS criteria.
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