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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:
24 June 1992 - 24 July 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The study pre-dates the adoption of the LLNA method and associated testing guidelines.

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
EC Number:
291-443-0
EC Name:
Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
Cas Number:
90411-66-8
IUPAC Name:
Hexanoic acid, 2-ethyl-, C12-15-alkyl esters
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Characterisation:
- Number: 20
- Weight: 200-300g
- Supplier: Breeding "Padre Antonio" Mariano Comense (Co) Italy

Selection justification:
These guinea pigs were used as recommended by the Ministerial decree, 5 December 1983 and in accordance with OECD Guidelines.

Housing:
The animals were caged, in groups of ten, in transparent polycarbonate cages (dimensions: 590x385x200h mm). The housing room was maintained under the following conditions:'
Temperature: 22 °C ± 2 °C
Humidity : 55% ± 15%
Air was changed at least 25 times per hour and maintained at pressure higher than the outside atmosphere.
Artificial lighting: 12 h/day.
Recordings of the housing conditions are being retained in 'Biolab s.o.s.' files.

Cleaning and disinfection:
The cages and the housing rooms were cleaned and disinfected before the animals were accomodated, then cleaning and disinfection were performed periodically.

Feeding:
Animals were fed, with a .standard complete pellet diet supplied by the company MUCEDOLA.

Water supply:
Animals were supplied with filtered water from an automatic watering system.

Quarantine:
Before allocation to the study, the animals were kept in quarantine for one week. During this period. they‘ were observed daily.
At the end. of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.

Animal selection:
The animals allocated to the study were selected randomly from those suitable, available at that time.

Animal identification:
The selected animals were caged in groups of ten per cage; each cage was identified with a label. The animals were identified by means of a numbered plastic tag stuck on their right ear.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml
Day(s)/duration:
Day 0 / 6 hours
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml
Day(s)/duration:
Day 7 / 6 hours
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml
Day(s)/duration:
Day 14 / 6 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml
Day(s)/duration:
Day 28 / 6 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
Skin preparation:
24 hours before testing, fur was removed by shaving a 50cm wide area on the back of the animals.

Administration:
The test consisted of an induction phase and a challenge phase.

Induction phase:
Day 0 - 7 - 14 treated group:
0.5 ml of test material was applied to all animals by means of an occlusive bandage.
The bandage was left in place for 6 hours.

Day 0 - 7 - 14 control group:
The same treatment was used with the control group but using distilled water instead of test material.

Challenge phase:

Day 28 - treated and control group:
All 20 guinea pigs were treated by applying test material on the skin on the right side of the animal while 0,5 ml of distilled water was placed on the skin on the left side. This is done by using an occlusive bandage. The bandage was left in place for 6 hours.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.5 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects observed
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Full tables appended in background information.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
During the study no signs of erythema and/or oedema were observed in treated and control animals.
The data concerning every single animal are reported in appendices l and 2.
Executive summary:

An allergic sensitization test was carried out on test material COSMACOL EOI.

20 guinea pigs were used in the test, 10 as controls and 10 were treated with the test material.

The test consisted, of 2 phases, an induction phase and a challenge phase.

During the induction phase the test material was applied on the skin at a dose of 0,5 ml/animal.

The dressing was left in place for 6 hours.

The same operation was repeated after 7 and 14 days.

The 10 control animals received the same treatment but distilled water was used instead of the test material.

28 days after the beginning ofi treatment a challenge phase was carried out on both groups of animals.

0,5 ml of test material was applied on the left flank of each animal and 0.5 ml of water was applied to the right side.

The dressing was left in place for 6 hours.

24, 48 anfi 72 hours after the challenge phase began, all animals are evaluated.

No signs of erythema or oedema were found. Therefore the test material can be classified as non-sensitizing.