Registration Dossier
Registration Dossier
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EC number: 271-013-9 | CAS number: 68513-69-9 A complex residuum from the distillation of the products from a steam-cracking process. It consists predominantly of aromatic and unsaturated hydrocarbons having carbon numbers greater than C7 and boiling in the range of approximately 101°C to 555°C (214°F to 1030°F).
Skin sensitisation
Administrative data
- 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:
- other: GLP compliant, near guideline study, available as unpublished report, restrictions in study design but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 10 per group
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Distillates (petroleum), light steam-cracked naphtha
- EC Number:
- 270-662-5
- EC Name:
- Distillates (petroleum), light steam-cracked naphtha
- Cas Number:
- 68475-80-9
- IUPAC Name:
- 68475-80-9
- Reference substance name:
- E000014200
- IUPAC Name:
- E000014200
- Details on test material:
- - Name of test material (as cited in study report): E000014200
- Physical state: dark amber to greenish blue coloured liquid; distinctive odour
- Lot/batch No.: no data
- Specific gravity: 0.92-0.98 (H2O = 1 at 39.2°F)
- Density: 0.9403 g/mL
- Solubility: negligible in water
- Boiling point: 350-575°F
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Camm Research, Wayne, New Jersey, USA
- Age at study initiation: Young adults
- Weight at study initiation: 300-500 g
- Housing: Individually in stainless steel, wire mesh bottom cages
- Diet: Agway guinea pig feed ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64-79°F (~17.8 -26°C)
- Humidity: 40-70%
- Air changes: at least 10 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 4 April 1990 To: 4 May 1990
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: Undiluted for induction phases 1 and 2 and as a 1:2 v/v dilution in mineral oil for induction 3.
Challenge: 1:4 v/v dilution in mineral oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: Undiluted for induction phases 1 and 2 and as a 1:2 v/v dilution in mineral oil for induction 3.
Challenge: 1:4 v/v dilution in mineral oil
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
- yes: 6 animals; applications of neat, 1:2, 1:4 and 1:8 v/v in mineral oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Control group: yes: vehicle control (0.5 ml mineral oil) and positive control (0.5 ml 0.3% DNCB)
- Site: dorsal midline
- Frequency of applications: weekly
- Duration: 3 weeks
- Concentrations: Undiluted for induction phases 1 and 2 and as a 1:2 v/v dilution in mineral oil for induction 3.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 13 days after last induction dose
- Exposure period: 24 hours
- Control group: vehicle control (0.5 ml mineral oil) and positive control (0.5 ml 0.2% DNCB)
- Site: on the opposite side of the dorsal midline from the induction test site
- Concentrations: 1:4 v/v in mineral oil
- Evaluation (24 hr after challenge): based on the Draize scoring method - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
Results and discussion
- Positive control results:
- Challenge exposure for DNCB resulted in a significantly higher erythema and oedema responses than that observed in the naive challenge control group (10/10 animals; severity index 3.6 for both 24 and 48 hours).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL 1:4 v/v
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL 1:4 v/v. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no response.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL 1:4 v/v
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL 1:4 v/v. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no response.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5 mL 0.2% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- well-defined to moderate to severe erythema in all 10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 mL 0.2% DNCB. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: well-defined to moderate to severe erythema in all 10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5 mL 0.2% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- slight to moderate to severe response in all 10 animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5 mL 0.2% DNCB. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: slight to moderate to severe response in all 10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0.5 mL mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 0.5 mL mineral oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no response.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0.5 mL mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0.5 mL mineral oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no response.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under these test conditions E000014200 was not a delayed contact sensitiser.
- Executive summary:
Male Hartley albino guinea pigs were dermally exposed to test article E000014200 (CAS 68475-80-9) neat at a volume of 0.5 mL for induction phases one and two and to a 1:2 v/v dilution (in mineral oil) for induction three. The test article was administered as a 1:4 v/v dilution (in mineral oil) for the challenge phase for both the induction/challenge and challenge control group animals.
Following challenge there were no responses in E000014200 or vehicle control animals whilst all 10 in the positive control group had responses.
E000014200 (CAS 68475-80-9) was not a delayed contact sensitiser and no classification is warranted under Dir 67/548/EEC or GHS/CLP.
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