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Administrative data

Description of key information

The target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) is considered to be a skin sensitiser, based on a BaP content of 1 - 1.5 %. BaP was shown to be a potent sensitiser in an assay using guinea pigs (Old et al. 1963).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
with reproducible test method
Qualifier:
no guideline available
Version / remarks:
year of study 1963
Principles of method if other than guideline:
Delayed hypersensitivity/contact sensitisation: Intradermal injection of the agents into the foot pad for induction in the presence of Freund´s adjuvant, followed by topical/epidermal challenge
(method according to: Gell PG and Benacerraf B J. Exp. Med. 113, 571 (1961)
GLP compliance:
no
Type of study:
intracutaneous test
Justification for non-LLNA method:
LLNA test method not available at time of the study
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3,4-benzpyrene (BP)
- Analytical purity: "highly purified" (acc. to report)
Species:
guinea pig
Strain:
Hartley
Sex:
female
Route:
intradermal
Vehicle:
other: emulsion in complete Freund´s adjuvant with saline
Concentration / amount:
125 µg into each front foot pad, total 250 µg
Day(s)/duration:
exposure period 2 - 3 wks
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: acetone-olive oil mixture (not further specified)
Concentration / amount:
0.001 %
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: acetone-olive oil mixture (not further specified)
Concentration / amount:
0.01 %
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No.:
#3
Route:
epicutaneous, open
Vehicle:
other: acetone-olive oil mixture (not further specified)
Concentration / amount:
0.1 %
Day(s)/duration:
24
Adequacy of challenge:
not specified
No.:
#4
Route:
epicutaneous, open
Vehicle:
other: acetone-olive oil mixture (not further specified)
Concentration / amount:
1 %
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
6, 16, and 10 were used for 3-methylcholanthrene (MC), BaP and 9,10-dimethyl-1,2-benzanthracene (DMBA), respectively
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 i.d.
- Exposure period: 2 - 3 weeks
- Test groups: 4
- Control group: 1
- Site: each foot pad
- Frequency of applications: 1x
- Concentrations: 250 µg (125 µg/0.1 mL into each front foot pad)
- Auxiliary agent: emulsion in complete Freund´s adjuvant with saline

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 - 3 weeks after induction
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site: ventral or dorsal shaved skin
- Concentrations: 0.001, 0.01, 0.1,and 1 % (one drop each applied)
- Evaluation (hr after challenge): 24

OTHER:
- Scoring system
according to Gell PG and Benacerraf B J. Exp. Med. 113, 571 (1961): from +++ to 0

Challenge controls:
PAH known to be contact sensitisers in this test system: MC and DMBA
Positive control substance(s):
yes
Remarks:
3- methylcolanthrene (MC) and 9,1-dimethyl-1,2-benzanthracene (DMBA)
Positive control results:
MC +++ (>= 0.1 %); DMBA +++ (1 %).
Dose-related intensity of the responses
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.001%
Clinical observations:
contact reactivity with score +
Remarks on result:
positive indication of skin sensitisation
Remarks:
score + indicates the onset of a sensitising effect
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.01%
Clinical observations:
contact reactivity with score ++
Remarks on result:
positive indication of skin sensitisation
Remarks:
score ++ shows a moderate sensitising response
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
Clinical observations:
contact reactivity with score +++
Remarks on result:
positive indication of skin sensitisation
Remarks:
score +++ demonstrates a clear sensitising response
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
Clinical observations:
contact reactivity with score +++
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
no application of substance during challenge
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
reponse - to +- (negative to slight erythema)
Remarks on result:
no indication of skin sensitisation
Remarks:
negative response on challenge

There was a dose-related increase in the intensity of the delayed contact reactivity. There was also cross-reactivity with MC and DMBA as challenging agent and BaP with previous inducer. The intensity of the response was dose-related but primarily expressed at the higher challenge doses, i.e. weaker than with BaP as challenger.

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
dose related intensity of the response with regard to the test substance concentration during challenge
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) as well as the read-across (source) compound, pitch (coal tar) [CAS No. 65996-93-2] are coal tar-borne UVCB substances consisting of a complex mixture of polycyclic aromatic hydrocarbons (PAH), predominantly of condensed four to five-ring aromatic ring systems which form a matrix that is practically insoluble in water. The GC-analytical profiles are very similar, and hence will be the physico-chemical and toxicological properties of these structure-related fractions. It is expected that the mammalian systemic and local toxicity of the target compound will not be higher than that of the read-across compound, pitch (coal tar).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The read-across (source) compound, pitch (coal tar) [CTPht], as heavy coal-tar distillate, shows a very similar PAH-profile: This is due to the fact that the considered coal-tar pitch is the high-molecular, "heavy" RESIDUE of a sequential fractionation procedure of coal tar with the temperature increasing, among others under vacuum distillation. On the other hand, the target compound is the high-termperature re-distillate of a high-molecular, heat-treated coal-tar fraction. This is expressed also in the respective fractions of total analysable GC-volatiles which amount to approx. 10% in coal-tar pich, while the GC volatiles of the target compound sum up to a comparable percentage of 13%.

3. ANALOGUE APPROACH JUSTIFICATION
In both cases, 1% or above account for BaP, which is an experimental skin sensitiser (see Old et al. 1963). Based on this finding and taking account of the classification criteria for this endpoint, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) has to be classified as a skin sensitiser the same way as CTPht.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across to the preceding entry:
Source substance: benzo[a]pyrene (benzo[def]chrysene), generic (commercial product);
Reference: Old LJ et al. 1993; WHO 1998; ATSDR 1995
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.001 %
Clinical observations:
contact reactivity with score +
Remarks on result:
positive indication of skin sensitisation
Remarks:
score + indicates the onset of a sensitising effect / test result is adopted for the target substance CTPht
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.01 %
Clinical observations:
contact reactivity with score ++
Remarks on result:
positive indication of skin sensitisation
Remarks:
score ++ shows a moderate sensitising response / test result is adopted for the target substance CTPht
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 %
Clinical observations:
contact reactivity with score +++
Remarks on result:
positive indication of skin sensitisation
Remarks:
score +++ demonstrates a clear sensitising response / test result is adopted for the target substance CTPht
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
Clinical observations:
contact reactivity with score +++
Remarks on result:
positive indication of skin sensitisation
Remarks:
test result is adopted for the target substance CTPht
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin Sensitisation

No data is available on sensitising effects of the target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0).

benzo[a]pyrene [BaP] is used as supporting substance to characterise the sensitising potential in analogy to CTPht.

Based on a the content of >1% of BaP, a strong experimental sensitiser, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) is classified as sensitising Cat. 1 by the registrant.