Registration Dossier

Administrative data

Description of key information

No particular irritation to skin and eye was noted in experimental standard studies. 
In the presence of UV-light (UVA), photo-induced human skin irritation was observed under working (bright sunlight) and experimental (artificial UV irradiation) conditions.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
other: Study according to national / international standard
Qualifier:
according to
Guideline:
other: Directive 83/467/EEC
Qualifier:
equivalent or similar 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: 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:
other: erythema and 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: 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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
other: Directive 83/467/EEC.
Qualifier:
equivalent or similar 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: 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:
2
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

No particular irritation to skin and eye was noted in experimental standard studies.

However, in the presence of UV-light (UVA), photo-induced human skin irritation was observed under working and experimental conditions (Crow et al. 1961).Human exposure to pitch (identity not specified) within a working environment under bright sunlight resulted in skin irritation. In addition, the same pitch experimentally applied on the skin of human volunteers as chloroform solution caused pronounced skin irritation after radiation with UV-light (UVA).The composition of the pitch utilised may be somewhat different from the registration substance due to differences in production conditions and distillation temperature. Basic constituents and consequentially basic effects will be the same for both substances. Thus, it is justified to use this study (Crow et al 1961) to indicate possible irritation effects of coal tar pitch, high temp. under UV-light irradiation.

Justification for classification or non-classification

No irritating effects have been observed after exposure to pitch, coal tar, high temp. under standard test conditions. 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.