Registration Dossier
Registration Dossier
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EC number: 270-737-2 | CAS number: 68477-54-3 A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
Toxicological information
Skin sensitisation
Currently viewing:
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- other: GLP compliant, guideline study available as unpublished report, restrictions in design and reporting, otherwise adequate for assessment.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:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 10 animals in test group
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- CAS 68478-10-4
- IUPAC Name:
- CAS 68478-10-4
- Reference substance name:
- E000044012
- IUPAC Name:
- E000044012
- Details on test material:
- - Name of test material (as cited in study report): E000044012
- Clear, pale yellow to yellow-coloured liquid; disagreeable odour
- Specific gravity: AP = 0.87 - 0.91 (H2O = 1 at 39.2°F)
- Flash point: AP = 75°F
- Density: 0.9651 g/mL (as determined by UBTL)
- Analytical purity: no data
- Test material data on file with the study sponsor
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: Sasco Inc., Omaha, Nebraska, USA
- Sex: 48 males
- Age at study initiation: young adult
- Weight at study initiation: Approximately 300 - 500 g
- Housing: Individually, in stainless steel, wire mesh bottom cages
- Diet: Agway guinea pig feed ad libitum
- Water: ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64 - 79°F
- Humidity: 40 - 70%
- Air changes: At least 10/h
- Photoperiod: 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 7 February 1990 To: 16 March 1990
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- E000044012 - 1:2 v/v dilution for induction; 1:4 v/v dilution for challenge
DNCB (positive control) - 0.3% for induction; 0.2% for challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- E000044012 - 1:2 v/v dilution for induction; 1:4 v/v dilution for challenge
DNCB (positive control) - 0.3% for induction; 0.2% for challenge
- No. of animals per dose:
- 10 (test, positive control and vehicle control groups)
4 (challenge controls ) - Details on study design:
- RANGE FINDING TESTS:
- 6 animals used for dose selection (irritation) phase.
- 0.5 mL of undiluted, 1:2, 1:4 and 1:8 v/v applied to shaved dorsal area.
- occlusive dressing
- 6 h application period
- scored after 24 and 48 h
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 mL of 1:2 v/v dilution
- Control group: 0.5 mL of mineral oil
- Site: dorsal surface
- Frequency of applications: once/week
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) after last induction: 13
- Exposure period: 6 h
- Site: naive site (opposite side of dorsal midline from induction applications)
- Concentrations: 0.5 mL of 1:4 v/v dilution
- Evaluation (hr after challenge): - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Study design: in vivo (LLNA)
- Statistics:
- Not required
Results and discussion
- Positive control results:
- Response grades, severity and incidence following challenge exposure to DNCP resulted in a significantly higher response than that seen in the naive challenge control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1:4 v/v
- 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: test group. Dose level: 1:4 v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no response.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1:4 v/v
- 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: test group. Dose level: 1:4 v/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no response.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: E000044012 challenge control
- Dose level:
- 1:4 v/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: E000044012 challenge control. Dose level: 1:4 v/v. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no response.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: E000044012 challenge control
- Dose level:
- 1:4 v/v
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: E000044012 challenge control. Dose level: 1:4 v/v. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no response.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2% DNCB in 80% ethanol
- 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: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.2% DNCB in 80% ethanol. 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:
- 0.2% DNCB in 80% ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- well-defined erythema in all 10 animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.2% DNCB in 80% ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: well-defined erythema in all 10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: DNCB challenge control
- Dose level:
- 0.2%
- No. with + reactions:
- 2
- Total no. in group:
- 4
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: DNCB challenge control. Dose level: 0.2%. No with. + reactions: 2.0. Total no. in groups: 4.0. Clinical observations: very slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: DNCB challenge control
- Dose level:
- 0.2%
- No. with + reactions:
- 2
- Total no. in group:
- 4
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: DNCB challenge control. Dose level: 0.2% . No with. + reactions: 2.0. Total no. in groups: 4.0. Clinical observations: very slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 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: negative control. Dose level: 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:
- negative control
- Dose level:
- 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: negative control. Dose level: 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:
- E000044012 was not a delayed contact sensitiser.
- Executive summary:
- The sensitization potential of E000044012 (CAS 68478-10-4) was investigated in 10 male guinea pigs dermally exposed to a 1:2 v/v dilution of 0.5 mL E000044012 in mineral oil for each of 3 induction phases. Following challenge with a 1:4 dilution response grades, severity and incidence were not greater than those at the control group site. The positive control, DNCB, produced significantly higher responses than in the control group which were free of dermal lesions throughout the study period. It is concluded that E000044012 (CAS 68478 -10 -4) is not a skin sensitiser and no classification is warranted under Dir 67/548/EEC or GHS/CLP.
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