Creosote oil, acenaphthene fraction

Endpoint summary

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 for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 for cross-reference:

reference to same study

Qualifier:

according to guideline

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.