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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1979-11-10 to 1979-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near-guideline, GLP-compliant study. Adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Method: other: API procedure (see Reference).
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: viscous hydrocarbon liquid
Details on test material:
No. 6 Heavy Fuel Oil (API 78-8 with Specific Gravity 0.99/2.7%S),Fuel oil No. 6, CAS No. 68553-00-4.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Camm Research Institute (Wayne, NJ)
- Age at study initiation: Young adult
- Housing: in stainless steel cages with indirect bedding
- Diet (e.g. ad libitum): Purina guinea pig chow ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: 11 days

IN-LIFE DATES: From: 29-10-1979 To: 15-12-1979

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: Not conducted since irritation tests in rabbits produced only minimal irritation

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 (3 times a week for 3 weeks)
- Exposure period: 6 hours
- Test groups: 1
- Site: shaved area (3" x 3"), depilatated with Neet on back
- Frequency of applications: 3 times a week for 3 weeks
- Duration: 3 weeks
- Concentrations: 0.5 mL (unchanged)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks post induction
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: left side of back
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 24 hours

Positive control substance(s):
yes
Remarks:
0.05% (w/v) chlorodinitrobenzene in absolute ethanol

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Mean Erythema score of 10 readings
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Mean erythema score was 0.22
Remarks on result:
other: Reading: other: Mean Erythema score of 10 readings. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score was 0.22.
Reading:
other: Mean erythema score at challenge
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Mean erytema score at challenge was 0.900
Remarks on result:
other: Reading: other: Mean erythema score at challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Mean erytema score at challenge was 0.900.
Reading:
other: Mean edema score of 1o readings
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Mean edema score was 0.010
Remarks on result:
other: Reading: other: Mean edema score of 1o readings. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Mean edema score was 0.010.
Reading:
other: Mean edema score at challenge
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Mean edema score at challenge was 0.200
Remarks on result:
other: Reading: other: Mean edema score at challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Mean edema score at challenge was 0.200.
Reading:
other: Mean erythema score of 5 readings
Hours after challenge:
24
Group:
positive control
Dose level:
0.05 % (w/v)
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Mean erythema score was 1.0889
Remarks on result:
other: Reading: other: Mean erythema score of 5 readings. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05 % (w/v). No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score was 1.0889.
Reading:
other: Mean erythema score at challenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.05% (w/v)
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
Mean erythema score at challenge was 1.6667
Remarks on result:
other: see Remark
Remarks:
Reading: other: Mean erythema score at challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% (w/v). No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Mean erythema score at challenge was 1.6667.
Reading:
other: Mean edema score of 5 readings
Hours after challenge:
24
Group:
positive control
Dose level:
0.05% (w/v)
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Mean edema score was 0.0667
Remarks on result:
other: Reading: other: Mean edema score of 5 readings. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% (w/v). No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Mean edema score was 0.0667.
Reading:
other: Mean edema score at challenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.05% (w/v)
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
Mean edema score at challenge was 0.5556
Remarks on result:
other: Reading: other: Mean edema score at challenge. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% (w/v). No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: Mean edema score at challenge was 0.5556.
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested

Any other information on results incl. tables

A statistically significant difference between sensitizing and challenge treatments for erythema and oedema was noted among the test animals, but the challenge scores were less than the sensitizing average, indicating that the test substance was non-sensitizing.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Results of a closed patch skin sensitisation study in guinea pigs indicate that the material was not a skin sensitiser.
Executive summary:

Skin sensitising potential was investigated in guinea pigs using a closed patch test procedure. Ten adult male albino guinea pigs were each treated with 0.5 mL of the test material, three times per week for three weeks. The patches were left in place for 6 hours before removal. Two weeks after final application, they were challenged with 0.5 mL of test material. Scores were taken at 24 hours according to the Draize scale. A naive control group of 10 animals and a positive control group of 10 animals were also included. The naive control group was treated with test substance in the challenge phase only. The positive control group was treated with a 0.05% (w/v) dilution of dinitrochlorobenzene in both the sensitizing and challenge phases.

A statistically significant difference between sensitizing and challenge treatments for erythema and edema was noted among the test animals, but the challenge scores were less than the sensitizing average, indicating that the test substance was non-sensitizing.

Based on results of the dermal challenge procedure the material was not considered to be a skin sensitiser.