Pitch, coal tar, high-temp., < 1% 4- to 5-membered condensed ring aromatic hydrocarbons

Endpoint summary

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

Reference

Reference 1

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

Reference 2

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

Reference

Reference 1

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

Reference 2

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

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.