Registration Dossier

Administrative data

Description of key information

AOH is irritating to skin but not irritating to the eye, based on experimental results of the closely structure-related tar oil creosote.
There is no evidence of respiratory irritation at ambient temperatures based on occupational experience (low vapour pressure of the substance). At elevated temperatures, exposure to vapours may produce irritating effects on the respiratory tract.

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: 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

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:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Erythema scores were ≥ 2.3 - ≤ 4.0 for two of three animals while oedema scores were ≥ 2.3 - ≤ 4.0 for three animals. According to EU criteria, the test material creosote is skin irritating Cat 2.
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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on skin and eye irritation is available for the substance distillates (coal tar), heavy oils (anthracene oil high (> 50 ppm) BaP, AOH) itself. Data obtained originate from the closely related tar oil creosote. Due to the similar production process (fractionated distillation of coal tar using overlapping conditions), composition of both substances correspond to each other. Major components are mid-range PAH for both substances (3- and 4-ring PAH) with some additional 2-ring PAH in creosote but not in AOH.

2-ring PAH have been tested demonstrating possible irritation to skin but not to the eye of rabbits. These effects are similar to that found for creosote. Using test results obtained with creosote may eventually overestimate the irritating potential of AOH as 2-ring PAH with known skin irritating potential are not present in AOH. The use of creosote as supporting substance in establishing the irritation potential of AOH can be considered as worst case. Thus, it is justified to use creosote as supporting substance in characterising the irritating potency of AOH.

Creosote was found to be skin irritating (Cat. 2 according to EU criteria) while at the same time not being irritating to the eye. Based on results of the supporting substance creosote, AOH is categorised as skin irritating according to EU criteria but simultaneously not being irritating to the eye.

For respiratory irritation, no experimental data has been located. Occupational experience gave no evidence of respiratory irritation. Reason may be the low vapour pressure of AOH at ambient temperature (0.6 Pa, see Chapter 1.3). However, exposure to vapours at elevated temperatures may produce irritating effects on the respiratory tract.


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), AOH 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.