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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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
Molecular formula:
not applicable
IUPAC Name:
Creosote
Test material form:
liquid
Details on test material:
- Test material quality: Creosote Type WEI B (Grade B)
- Substance type: organic
- Analytical purity: not applicable (UVCB substance, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
Specific details on test material used for the study:
- Name of test material (as cited in study report): Creosote SNCF
- Type of test material: Creosote Type WEI B (Grade B)
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
- Source and lot/batch No.of test material: SNCF, 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): no data
- 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: (no effects were observed in any of the test animals)
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: (no effects were observed in any of the test animals)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: (two animals with a mean score of 0.667 each)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: (one animal with a mean score of 0.667)
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:
GHS criteria not met
Remarks:
as well as EU criteria according to CLP regulation
Conclusions:
All individual effect scores (mean score from gradings at 24, 48, and 72 hours after test material instillation) remained below cut-off limits for classification: cornea < 1, iris < 1, redness < 2, oedema < 2 .
Under the conditions of the test, the test material creosote SNCF, WEI-Type B is not irritating to the eyes of rabbits.