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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other: GLP compliant, near guideline study, available as unpublished report, restrictions in study design but otherwise adequate for assessment.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:
1990
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

Constituent 1
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
Constituent 2
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

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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