Registration Dossier
Registration Dossier
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EC number: 292-607-4 | CAS number: 90640-86-1 Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Creosote
- EC Number:
- 232-287-5
- EC Name:
- Creosote
- Cas Number:
- 8001-58-9
- IUPAC Name:
- 8001-58-9
- Details on test material:
- - Name of test material (as cited in study report): Creosote SNCF
- Creosote Type WEI B (Grade B)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture.)
- Impurities (identity and concentrations): not applicable
- Composition of test material, percentage of components: see below "Any other information on materials...."
- Batch No. 4460 A 93
- Storage condition of test material: Stable at room temperature under exclusion of UV light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.8 ±0.1 kg
- Housing: polystyren cage, 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-3
- Humidity (%): 50 +-20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 1, 24, 48, 72 h post-instillation
- Number of animals or in vitro replicates:
- 3 (male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
SCORING SYSTEM: Numeric Draize scale:
Grades 0 to 3 for severity of redness of conjunctivae as well as lacrimation,
grades 0 - 4 for oedema and corneal effects,
grades 0 - 2 for iris effects.
EVALUATION: according to EU classification system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Very slight chemosis (score 1 in one animal only) and slight (score 1) to moderate (score 2) redness of the conjunctivae between 1 and 48 h, the moderate effect in one animal after 24 h. No effect on the iris and cornea.
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- All individual effects scores over time remained below cut-off limits for classification: cornea < 2, iris < 1, redness < 2.5, oedema < 2.
Under the conditions of the test, the test material, Creosote SNCF, is not irritating to the eyes of rabbits.
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