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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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.

Diss Factsheets

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:
1993
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

Constituent 1
Reference substance name:
Creosote
EC Number:
232-287-5
EC Name:
Creosote
Cas Number:
8001-58-9
IUPAC Name:
8001-58-9
Constituent 2
Reference substance name:
A complex combination of monocyclic aromatic hydrocarbons, polycyclic aromatic hydrocarbons, tar acids and tar bases, obtained by the distillation of coal tars produced by the high-temperature destructive distillation of bituminous coal to form coke. It consists of hydrocarbons boiling in the range of approximately 200°C-355°C
IUPAC Name:
A complex combination of monocyclic aromatic hydrocarbons, polycyclic aromatic hydrocarbons, tar acids and tar bases, obtained by the distillation of coal tars produced by the high-temperature destructive distillation of bituminous coal to form coke. It consists of hydrocarbons boiling in the range of approximately 200°C-355°C
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

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.