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Administrative data

Description of key information

No experimental data is available with Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8] (CTPhtht) itself.

But, no particular irritation to skin and eye of rabbits was noted in experimental standard studies with the structure-related supporting substance Coal-tar pitch, high temp. [CAS no. 65996-93-2].

These results are adopted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

- ANALOGUE APPROACH JUSTIFICATION
Coal-tar pitch, high temp. [CAS no. 65996-93-2] is the precursor of CTPhtht and used as structure-analogue: similar structure and phys-chem. properties like the target substance, Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8] (CTPhtht) but potentially higher bioavailability than CTPhtht.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across to preceding entry:
Source test material: pitch, coal tar (CTP)
Reference: Sterner et al. 1987, skin irritation
GLP compliance:
yes
Irritation parameter:
erythema score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: on the intact and scarified skin
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: on the intact and scarified skin
Endpoint:
skin 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
Qualifier:
according to guideline
Guideline:
other: Directive 83/467/EEC
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Physical state: solid, black powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremerförde/Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: cage, single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2 °C
- Humidity (%): 50 - 86 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12


Type of coverage:
occlusive
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 g

Duration of treatment / exposure:
4 hour(s)
Observation period:
readings: 1 h, 24, 48, and 72 h after removal of the cover
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- skin intact and scarified

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

SCORING SYSTEM: according to Draize
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: on the intact and scarified skin
Irritation parameter:
edema score
Basis:
animal: 1 - 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: on the intact and scarified skin
Irritant / corrosive response data:
There was no skin reaction over the observation time of 72 h (score 0 for all parameters).
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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
Qualifier:
according to guideline
Guideline:
other: Directive 83/467/EEC.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Physical state: solid, black powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremerförde/Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: cage, single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2 °C
- Humidity (%): 50 - 86 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):
1, 24, 48, and 72 h post-application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, eye not rinsed

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein after 24 and 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
No irritation effects after 24 h (scores 0)
Interpretation of results:
GHS criteria not met
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

- ANALOGUE APPROACH JUSTIFICATION
Coal-tar pitch, high temp. [CAS no. 65996-93-2] is the precursor of CTPhtht and used as structure-analogue: similar structure and phys-chem. properties like the target substance, Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8] (CTPhtht) but potentially higher bioavailability than CTPhtht.

Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across to preceding entry:
Source test material: pitch, coal tar (CTP)
Reference: Sterner et al. 1987, Eye irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No irritating effects have been observed after exposure to pitch, coal tar, high-temp. under standard test conditions. Adopting these results for Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons [EC no. 701-305-8] (CTPhtht), classification for irritation/corrosion is not required.

Potential UV-light-induced skin irritating effects (see above) are not taken into account for classification.