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Skin sensitisation

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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: see 'Remark'
Remarks:
The study was conducted in compliance with OECD test guideline number 406 and Good Laboratory Practice Standards. The study merits a reliability rating of 1 according to the criteria of Klimisch as regards use of the study for the material tested. However, because the data are being use as read-across for a similar material, the reliability rating is reduced to 2, reliable with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Principles of method if other than guideline:
Due to technician error, aliquots were inadvertently not collected for the first induction. This deviation did not compromise any aspect of this study.
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Exisiting study

Test material

Constituent 1
Reference substance name:
156619-82-8
Cas Number:
156619-82-8
IUPAC Name:
156619-82-8
Details on test material:
Low overbased calcium alkylbenzene sulfonate derived from 80% C20-24 + 20% C14-C18 olefin blend.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc.
- Age at study initiation: 4 to 6.5 weeks
- Weight at study initiation: 327 to 468 grams
- Housing: Animals will be individually housed in wire mesh suspension cages.
- Diet (e.g. ad libitum): Ad libitum of Purina Guinea Pig Chow (or other comparable diet)
- Water (e.g. ad libitum): Ad libitum of tap water
- Acclimation period: At least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour Iight/12-hour dark cycle

IN-LIFE DATES: From:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
A 50% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P. was chosen for use at induction. A 5% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P. was chosen for use at primary challenge.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
A 50% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P. was chosen for use at induction. A 5% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P. was chosen for use at primary challenge.
No. of animals per dose:
Undiluted test substance used as induction: 20 test animals and 5% w/v concentration of the test material used as primary challenge: 20 test animals and 10 naive controls.
Details on study design:
RANGE FINDING TESTS: Irritation tests

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 0
- Site: On the backs, near shoulders, of the animals
- Frequency of applications: 1
- Duration: weekly
- Concentrations: 50% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Approximately two weeks after the last induction exposure
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1 naive control group
- Site: On the backs of the animals, not the same spot as the induction dose
- Concentrations: 5% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P.
- Evaluation (hr after challenge): 24 and 48 hours after removal of test material

OTHER: No rechallenge exposures were applied.
Challenge controls:
During the challenge phase, 5% w/v concentration of test material in Spectrum Mineral Oil Light, U.S.P. were applied to naive controls.
Positive control substance(s):
yes
Remarks:
historical

Study design: in vivo (LLNA)

Positive control substance(s):
other: DNCB (historical)
Statistics:
Arithmetic mean

Results and discussion

Positive control results:
Following induction of DNCB at various concentrations in acetone, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
14
Total no. in group:
19
Clinical observations:
Edema was observed on site of 5 test animals. Originally 20 animals were in the test group. One animal was found dead on the day of 24 hour scoring of the primary challenge. The gross necropsy findings in this animal were those seen in agonal animals.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 14.0. Total no. in groups: 19.0. Clinical observations: Edema was observed on site of 5 test animals. Originally 20 animals were in the test group. One animal was found dead on the day of 24 hour scoring of the primary challenge. The gross necropsy findings in this animal were those seen in agonal animals..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
17
Total no. in group:
19
Clinical observations:
Edema was observed on site of 5 test animals. Originally 20 animals were in the test group. One animal was found dead on the day of 24 hour scoring of the primary challenge. The gross necropsy findings in this animal were those seen in agonal animals.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 17.0. Total no. in groups: 19.0. Clinical observations: Edema was observed on site of 5 test animals. Originally 20 animals were in the test group. One animal was found dead on the day of 24 hour scoring of the primary challenge. The gross necropsy findings in this animal were those seen in agonal animals..
Reading:
1st reading
Hours after challenge:
24
Group:
other: naive control group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive control group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: naive control group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive control group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Following primary challenge using the test substance at a level of 5%, the incidence of grade 2 responses or greater in the test group (17 of 19) was compared to that of the naive control group (0 of 10). The incidence and severity of these responses in the test group were substantially greater than those produced by the naive control group indicating that sensitization had been induced.
Executive summary:

The procedure used was based on that of Buehler. Hartley albino guinea pigs were used in this study. At the study initiation, the body

weights ranged from 327 to 468 grams (including the pilot animals) and the animals' ages ranged from approximately 4 to 6.5 weeks.

The study was initiated using 38 guinea pigs. However, due to the death of one test animal, this study was completed using 37 guinea pigs. This study was conducted in three phases as indicated: primary irritation, induction of sensitization, and primary challenge. A 50% w/v concentration of the test substance in Spectrum Mineral Oil Light, U.S.P. was chosen for use at induction. A 5% w/v concentration of test substance in Spectrum Mineral Oil Light, U.S.P. was chosen for use at primary challenge. Following primary challenge using the test substance at a level of 5%, the incidence of grade 2 responses or greater in the test group (17 of 19) was compared to that of the naive control group (0 of 10). The incidence and severity of these responses in the test group were substantially greater than those produced by the naive control group indicating that sensitization had been induced.