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Administrative data

Description of key information

No experimental data is available with petro pitch. No particular irritation to skin and eye of rabbits was noted in experimental standard studies using the structure-related substance pitch, coal tar, high temp.  

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
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
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:
other: none
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): luke-warm water
- Time after start of exposure: 4 h


SCORING SYSTEM: according to Draize
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: score 0 in all animals at any time point both on the intact and scarified skin
Irritation parameter:
edema score
Basis:
animal: 1 to 6
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: score 0 in all animals at any time point both on the intact and scarified skin
Irritant / corrosive response data:
There was no skin reaction over the observation time of 72 h (score 0).
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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
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
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:
other: none
Controls:
not required
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:
Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed


SCORING SYSTEM: according to Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp: no data / biomicroscope: no data / fluorescein: after 24 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #5
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal: #1, #3, #4
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: #2, #5, #6
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
No irritation effects after 24 h (scores 0)
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The experimental results obtained with pitch, coal tar, high-temp. are assumed to be applicable to petro pitch, too, because of their close structural similarity.

After application of coal-tar pitch to the skin of rabbits for four hours, no skin reaction was observed in any of the animals over the complete observation period.

Noticeable eye irritation could only be observed at one hour post-application. 24 hours after application, effects had disappeared.

Overall, no irritating effects of coal-tar pitch could be observed. In analogy, also petro pitch is assessed not to produce relevant irritating effects either to the skin or in the eye.

However, the possibility of skin irritation to occur in workers in the presence of sun-light should be taken into account, since photo-induced skin reaction are known from exposure to coal-tar pitch.

For respiratory irritation, no experimental data has been located. Occupational experience gives no evidence of respiratory irritation. This is in line with the results of the skin and eye irritation studies. Reason may be the low irritating potential together with the low vapour pressure of petro pitch. At elevated temperatures, exposure to vapours may produce irritating effects on the respiratory tract.

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, petroleum, arom., classification for irritation/corrosion is not required.

Potential UV-light induced skin irritating effects (see above) are not taken into account for classification as conditions causing this effect do not correlate to standard test procedures.