Registration Dossier

Administrative data

Description of key information

Based on experimental findings with the structure-analogous substance creosote, wash oil is identified as skin irritating Cat. 2 (CLP regulation) while at the same time not being irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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: polystyrene 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
9 and 12 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: bandage semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water-moistened gauze
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scale with grades 1 to 4 for severity of erythema and oedema
Data evaluation: According to directive 91/325/EEC: irritating = score >= 2 in 2/3 animals for >= 24 h for erythema or oedema
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
2.2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
3.1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
Mean scores per animal were 2 or distinctly higher at any time point until 72 h with mean scores over time >2 for erythema (2/3 animals) or >3 for oedema (3/3 animals).
Other effects:
Skin dryness prevailed between day 4 and 11 in 2 animals.

Table for skin irritation study

Score (average of three animals investigated)

time

Erythema

Edema

Average Draize scores
(0 to maximum 4)

60 min

2.3

4.0

24 h

2.7

4.0

48 h

2.3

3.3

72 h

1.7

2.0

Average score

24h, 48h, 72h

2.2

3.1

Reversibility: *

c

c

Time for reversibility in all animals (score 0)

7 d

6 d

*   c :    completely reversible
  n c :    not completely reversible
     n :    not reversible

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the test material, creosote SNCF, is irritating to the skin of rabbits.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
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
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

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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

No data is available for creosote oil, acenaphthene fraction (wash oil) itself. Data obtained for irritation originate from the closely related tar oil creosote and from some major components of wash oil (naphthalene and methylnaphthalenes). Due to the similar production process (fractionated distillation of coal tar using overlapping conditions), composition of both oils is quite similar. Major components are two and three ring PAH with creosote oil containing slightly less methylnaphthalenes and somewhat more of higher molecular weight PAH (phenanthrene to fluoranthene). The irritating potential of both materials can be considered to be similar. In combination with the information from the naphthalenes, the irritating potential of wash oil is assessed as being examined satisfactorily. Hence, creosote and the wash oil constituents naphthalene and 1- and 2-methylnaphthalene are used as supporting substances for characterisation of the irritating effects of wash oil.

Skin irritation

A study according to OECD TG 404 demonstrated the supporting substance creosote to be skin irritating (criteria according to CLP regulation). Based on this test, wash oil is characterised as skin irritating Cat. 2 (CLP Regulation (EC) No 1272/2008). The skin irritation tests with naphthalene and 1- and 2-methylnaphthalene (TG: USA Code of Federal Regulations, Title 16, Section 1500.41) are not valid as test conditions deviate substantially from present test requirements. Results of these tests (test substances not irritating) are disregarded.

Eye irritation

In an eye irritation study (OECD TG 405), no irritation potential could be demonstrated for the test substance creosote. Tests with naphthalene and 1- and 2-methylnaphthalene (TG: USA Code of Federal Regulations, Title 16, Section 1500.42) did as well not indicate a relevant irritation potential for these components of wash oil. The procedure for this eye irritation test is much closer to the OECD/EU test guideline than the procedure of the skin irritation test. Hence, results can be used as supporting evidence. Based on experimental evidence obtained with supporting substances, wash oil is characterised as not being irritating to the eye.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on experimental evidence (study according to OECD TG 404 with supporting substance creosote), wash oil is to be classified as skin irritating Cat. 2 based on criteria of Regulation (EC) No 1272/2008. Test results for eye irritation do not demonstrate a relevant eye irritating potential. Classification for eye irritation is not required.