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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted 1992
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
Molecular formula:
Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
IUPAC Name:
Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
Details on test material:
- Name of test material (as cited in study report): SAT 970 396, DHW 80
- Physical state/colour: beige wax
- Lot/batch No.: 128/6
- Expiration date of the lot/batch: 1998-10-17
- Storage condition of test material: room temperature, darkness

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH, D-16352 Schönwalde
- Weight at study initiation: 341 - 443g
- Housing: guinea pigs were housed in polycarbonate (macrolone type IV, floor area 1800 cm²) cages, two or three to a cage
- Diet: pelleted diet "Altromin 3122" from Altromin, D-32791 Lage, Lippe; ad libitum; analysis for major nutritive components and significant contaminants are performed regularly
- Water: Vitamin C enriched domestic quality water, acidified to pH 2.5 with hydrochloric acid to prevent microbiological growth; ad libitum; analysis for possible contaminants were performed regularly
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-09-23 To: 1997-10-31

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: sesame oil
Concentration / amount:
undiluted test substance
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: sesame oil
Concentration / amount:
undiluted test substance
No. of animals per dose:
10 (in control), 20 (in test group)
Details on study design:
RANGE FINDING TESTS: With two additional animals suitable concentrations of the test article were assessed for irritancy. The procedures were identical to those used in the main study. Sesame oil was used as vehicle for dilution of test substance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: test substance
- Control group: distilled water
- Site: left flank
- Frequency of applications: every 7 days
- Duration: day 0 - 21
- Concentrations: undiluted test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 hours
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: right flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 hours after removal of test patch
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It is concluded that in this Buehler Test the SAT 970 396, batch No. 128/6, was not generative of provoking a delayed contact hypersensitivity in guinea pigs.