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EC number: 920-912-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
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:
- 1 999
- 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
- Test material form:
- solid
- Details on test material:
- name: SEPIFEEL ONE
batch: 98174300
aspect: white solid
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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