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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:
11/01/99-12/02/99
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test performed in 1999.
LLNA method (OECD 442 B) was adopted in 2010.

Test material

Constituent 1
Test material form:
solid
Details on test material:
name: SEPIFEEL ONE
batch: 98174300
aspect: white solid
Specific details on test material used for the study:
Substance reference
The Sponsor sent to the Laboratory 1 plastic flask of the substance SEPIFEEL ONE, batch98174300.
It was white compact pieces.
This substance was coded in the Laboratory under the référence 98-4787.

Storage
The substance was stored at ambient temperature and out of the light in a room especially fitted out to that effect.
A sample of the substance was filed in the samples library of the Laboratory as a reference where it will be kept
until its expiry date or for a maximum period of 10 years.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Remarks:
Hartely albino
Sex:
female
Details on test animals and environmental conditions:
REACTIVE SYSTEM
Species : Hartley albino guinea-pigs
Origin : Charles RIVERSupplier (76410 St AUBINLES ELBEUF, France)
Weight at the beginning of acclimatization: inferior or equal to 500 g (main test)
Sex: nulliparous and non-pregnant females
Number : 38
- for preliminary tests: 8
2 for the determination of the highest irritant dose (irritation of level erythema 2) after intradermal injection,
4 for the determination of the highest irritant dose (irritation of level erythema 2) by topical application,
2 for the determination of the highest non-irritant dose by topical application.
-for the main test : 30
20 for the treated group
10 for the control group

Acclimatization : for at least 5 days before the beginning of the test
Identification : each animal was identified individually by auricular ring and the corresponding number was written on a label put on its cage.
Housing: the animals were housed at the rate of 1 per cage, in 31 cm x 46 cm x 19 cm polypropylene cages with stainless steel lid. The litter renewed regularly was composed of dust-free wood shavings. It was delivered by SICSA (94142 ALFORTVILLE, France).
The cages were placed in limited-access premises, of 7 m x 4 m x 3 m, maintained in slight overpressure (a minimum of 10 mm of water), under air-conditioned temperature (t = 21 it 3°C) and controlled relative humidity (HR = 50 + 20%) except during washing cycles and whose renewal in non recycled filtered air (on 99% filter) was performed at the rate of about 10 cycles per hour. The artificial lighting ensured a sequence of 12 hours light, 12 hours dark. All the employees who entered the animal house put on specific clothes.
Feeding: the complete diet was supplied under pelleted form 106, which guaranteed an appropriate ascorbic acid content, delivered by UAR (31360 EPINAYSURORGE, France).
Drinking : tap water distributed in polypropylene feeding-bottles with stainless steel teat. A sample of water was taken after each technical intervention from the pipes and every 6 months at least and sent for chemicophysical and bacteriological analysis to a specialized control organization.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
CONTROL GROUP

On day one:
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region cleared of hair on each side of the midline.
1) FCA diluted at 50 % with distilled water (v/v)
2) Distilled water (vehicle)
3) mixture 50/50 of the solutions 1 and 2 (v/v)

On day 7: following a rest period of 6 days, animals were closely-clipped.
As the substance was not a skin irritant, the test area was painted with 0.5 ml of 10% sodium lauryl sulfate in petrolatum, in order to create a local irritation. This treatment was performed in the 2 groups of animals (treated and control).

On day 8: topical application
0.50 ml of vehicle (distilled water) was deposited on the patch composed of a 8 cm rectangle of filter paper (2 x 4 cm), put on a 8 cm rectangle of gauze (2 x 4 cm) itself put on a 25 cm square of Blenderm(9 occlusive film. The occlusive dressing was held in contact with a Micropored adhesive film which surrounded the trunk of the animal, for 48 hours - 1 hour.

On day 10 : patches were removed and skin reactions were observed and reported in the work document reserved for that effect.
Day(s)/duration:
10
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
TREATED GROUP

On day one:
Three pairs of intradermal injections of 0.1 ml volume were given in the same sites and order as in the control animals.
1) FCA diluted at 50% with distilled water (v/v)
2) test substance at the dose previously defined (MICID) (the substance and the vehicle were put on oven at 60°C and the tested solution was homogenized by successive suckings and forcings back with a Syringe without needle).
3) test substance at the same dose as in 2 in a mixture 50/50 (v/v) of FCA and distilled water (v/v) (the Substance and the vehicle were put on oven at 60°C and the tested solution was homogenized by successive suckings and forcings back with a syringe without needle).
In injection 3, the water soluble substance suspended in FCA prior to combining with the aqueous phase.
Injections 1 and 2 were given close to each other and nearest the head, while the injection 3 was given towards the caudal part of the test area.

On day 7: following a rest period of 6 days, animals were closely-clipped.
As the substance was not a skin irritant, the test area was painted with 0.5 ml of 10% sodium lauryl sulfate in petrolatum, in order to create a local irritation. This treatment was performed in the 2 groups of animals (treated and control).

On day 8: topical application
0.50 ml of not neutralized test substance at the MICT was applied according to the method previously defined and let in contact with the skin for 48 hours +/- 1 hour.

On day 10 : patches were removed and skin reactions were observed and reported in the work document reserved for that effect.
Day(s)/duration:
10
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Following a rest period of l l days, the guinea-pigs from the 2 groups were closely-clipped on each side of the spinal column at dorsal lumbar level, in an area which has never been in contact with the substance before.
0.20 ml of the neutralized test Substance at its MNIC and 0.2 ml of the neutralized substance at its MNIC/2 were respectively applied to 2 patches each one composed of a square of 2 cm filter paper, put on a 4 cm square of
gauze, itself put on a 25 cm Blenderm(8) occlusive film. The patches were held on one of the flanks of the animal by a Micropore® film.
The occlusive dressings were let in contact for 24 hours +/- 1 hour.
Day(s)/duration:
24 hours
Adequacy of challenge:
other: neutralized test substance at its MNIC and at its MNIC/2
No. of animals per dose:
20 for the treated group
10 for the control group
Challenge controls:
The Group 1 (negative control) was submitted to the same experimentation as Group 2 (treated group) during the challenge phase.
Positive control substance(s):
yes

Results and discussion

Positive control results:
The sensitivity and reliability of the experimental technique were assessed in the study Te 670 from November 10 to December 04, 1998, with a reference substance known for its skin sensitisation potential = 2mercaptobenzothiazole (CAS N° 149-30-4 / EINECS N° 205-736-8 - usual name = Kaptax) used under the following conditions :
MICID = 1 % in olive oil
MICT = 25% in petrolatum + skin irritation to sodium lauryl sulfate
MNIC = 2% and 5% in petrolatum
The percentage of reactive animals during the challenge exposure was equal to 100%.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Taking into account the criteria defined by the EEC 67/548 Directive and its successive amendments, the substance SEPIFEEL ONE was classified as non sensitizing by contact with the skin
Executive summary:

RESUME/SUMMARY

Test substance : SEPI FEEL ONE batch 98 174300

Principle of the study :

The aim of the study was to assess, in 30 guinea-pigs, the skin sensitisation potential of the test substance. The effect was potentiated by the injection of Freund's Complete Adjuvant. The animals were initially exposed to the test product by intradermal injection and epidermal application (induction exposure). Following a rest period of 10 to 14 days (induction period), the animals were exposed to a challenge dose.

The extent and degree of Skin reaction to the challenge exposure in the test animals were compared with those demonstrated by control animals which underwent sham treatment during

induction and received the challenge exposure.

The test substance was classified in accordance with the EEC 67/548 Directive and its amendments.

Dates of the study: from 11/01/99 to 12/02/99

Results :

percentage of reactive animals : 0%

Conclusion:

The test substance is classified among the substances non sensitizing by contact with the skin.