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Diss Factsheets

Toxicological information

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
Study period:
1994-02-21 to 1994-04-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12th 1981; updated July 17th, 1992
Deviations:
not applicable
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study was performed 1994 prior to implementation of LLNA and appropriate in vitro methods to avoid animal testing

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated
IUPAC Name:
Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: E 06213804 (date of production: 1994-12-10), soft wax
- Expiration date of the lot/batch: Stable until December 1995
- Purity test date: 1994-01-20

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark, at room temperature, in a fume cupboard
- Stability under test conditions: Stable until December 1995

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Paraffinum Liquidum, DAB, viscous, used as vehicle

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
4, 20 and 100 %; (0.5g of test substance in vehicle or prepared with vehicle or 0.5 mL of vehicle control)
Day(s)/duration:
Treatment at day 1, 8 and 15; Observation period day 16 to day 28.
Adequacy of induction:
other: primary not irritating concentration
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
100% (0.5 g of test item was prepared with 0.3 mL Paraffin vicous DAB)
Day(s)/duration:
Dermal challenge at day 29. Evaluation of dermal reactions at day 30 and day 31.
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 at control group
20 at treatment group
Details on study design:
RANGE FINDING TESTS:
Yes Determination of the primary not irritating concentration
2 animals per dose. Left flank was clipped.
Dose tested: 4, 20 and 100 % in paraffin oil (DAB)
Exposure: occlusive, 6 hour.
24 hours after removal of patch, the treated skin area was examined for erythema and edema building. No erythema or edema could be detected at any dose group.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours each
- Test groups: 1
- Control group: 1
- Site: left flank, clipped
- Frequency of applications: day 1, 8 and 15
- Duration: 6 hours
- Concentrations: 100 % moistened with paraffin oil (0.5 g with 0.3 mL Paraffin oil DAB)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Site: right flank, clipped
- Concentrations: 100% moistened with paraffin oil (0.5 g with 0.3 mL Paraffin oil DAB)
- Evaluation (hr after challenge): At challenge phase 24 hours and 48 hours after removal of occlusive patch no reaction of the skin could be observed either at all animals treated nor in vehicle control animals.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Vehicle
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Vehicle
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results from an in Buehler sensitization test in Pirbright-White guinea pigs the test item is a non sensitizer skin.
Executive summary:

In order to assess the skin sensitizing property of Hostacerin DGSB one OECD 406 study (Buehler) in guinea pigs is available. In a pretest the primary non irritating concentration was determined in 2 animals per dose. Doses tested were 4, 20, 100 % in paraffin oil (DAB) which were exposed to the left flank and covered occlusive for 6 hours.24 hours after removal of patch, the treated skin area was examined for erythema and edema building. No erythema or edema could be detected at any dose group.

For the main study 20 female guinea pigs were treated with 0.5g of 100% test item prepared in paraffin oil (DAB) and 10 animals of control group were treated with 0.5 mL of Vehicle. Dermal induction was performed on the clipped left flank at days 1, 8 and 15 using the same application scheme as for the pretest. 24 hours after removal of patch, the treated area was examined for erythema and edema building. Days 16 to 28 were treatment free. At day 29 the challenge was performed on the untreated, clipped right flank. Dose group and control group were treated identically. Each 0.5g of 100 % test item prepared in paraffin oil (DAB) was applied the clipped backmost right flank and 0.5 mL of vehicle was applied to the anterior part of the clipped right flank. The treated area was covered occlusive for a period of 6 hours. At challenge phase 24 hours and 48 hours after removal of occlusive patch the treated areas were examined for erythema and edema buildng. No reaction of the skin could be observed either at all animals treated nor in vehicle control animals.