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Diss Factsheets
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EC number: 947-136-5 | 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, other
- Remarks:
- in vivo
- Type of information:
- other: read across from supporting substance (analogue substance or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 7th to September 21st, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test results described do not totally comply with the specific testing guideline but they are sufficient to accept the data. The complete justification for the Read Across approach is reported in the Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- test on guinea pig already available
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (Saint-Aubin-Lès-Elbeuf, 76410 Cléon, France).
- Age at initiation of treatment: young adult (about 6 weeks old).
- Body weight range at initiation of treatment: 250 - 550 g.
- Diet: pelleted complete guinea-pig diet ad libitum
- Water: softened and filtered mains drinking water, ad libitum analysed at least once a year for chemical contaminants and at least twice a year for bacterial contaminants
- Caging: animals housed in groups according to EEC/86/609 in stainless steel mesh cages (internal dimensions 500 x 600 x 200 mm).
ENVIRONMENTAL CONDITIONS
- Housing: in an air-conditioned building (building G4)
- Temperature : 19 ± 3 °C
- relative humidity : ≥ 31 % R.H.
- air changes : ≥ 22 air changes per hour
- lighting cycle : 12 hours light (artificial)/12 hours dark
Results and discussion
- Positive control results:
- 80 to 100 % of sensitized animals are usually obtained.
In vivo (non-LLNA)
Results
- Remarks on result:
- other: see results below
Any other information on results incl. tables
Treated groups:
Biopsies performed at 24 hours | Biopsies performed at 48 hours | ||||||||||
Animal (sex,number) | M62531 | M62533 | M62535 | M62537 | M62539 | M62534 treated area | M62534 control area | M62536 | M62538 | M62540 | M6262541 |
EPIDERMIS | |||||||||||
Acanthosis | moderate | minimal | minimal | minimal | slight | slight | slight | minimal | slight | minimal | slight |
Hyperkeratosis | moderate | slight | slight | moderate | moderate | moderate | moderate | marked | moderate | moderate | marked |
Exocytosis | minimal (focal) | - | - | - | - | minimal (focal) | - | - | - | - | - |
Spongiosis | minimal (basal) | - | - | - | minimal (basal) | minimal (focal) | - | - | - | - | - |
DERMIS | |||||||||||
Mononuclear cell infiltration | slight | slight | slight | slight | slight | slight | slight | slight (1) | slight | slight | slight |
Folliculitis | - | - | - | - | minimal | - | - | - | - | - | - |
Oedema | minimal | - | - | - | - | - | - | - | - | - | - |
Biopsies performed at 24 hours | Biopsies performed at 48 hours | ||||||||||
Animal (sex,number) | F62543 | F62545 | F62547 treated area | F62547 control area | F62549 | F62551 | F62542 | F62544 | F62546 | F62548 | F62550 |
EPIDERMIS | |||||||||||
Acanthosis | slight | slight | minimal | slight | slight | moderate | slight | minimal | slight | minimal | slight |
Hyperkeratosis | moderate | moderate | moderate | moderate | moderate | marked | moderate | moderate | moderate | moderate | moderate |
Exocytosis | - | - | - | minimal (multifocal) | - | - | - | - | - | - | - |
Spongiosis | - | - | - | minimal (basal) | - | - | - | - | - | - | - |
Scab(s) | - | present | - | - | - | - | present | - | - | - | - |
Ulceration | - | minimal (focal) | - | - | - | - | - | - | - | - | - |
DERMIS | |||||||||||
Mononuclear cell infiltration | slight | slight (1) | minimal | slight (1) | slight | slight | slight | slight | slight | slight | slight |
Folliculitis | - | - | - | - | - | - | - | - | - | minimal | - |
Oedema | - | - | - | - | - | - | - | - | - | - | - |
Control group:
Biopsies performed at 24 hours | Biopsies performed at 48 hours | |||||||||
Animal (sex,number) | M62521 | M62523 | M62525 | F62527 | F62529 | M62522 | M62524 | M62526 | F62528 | F62530 |
EPIDERMIS | ||||||||||
Acanthosis | minimal | - | minimal | slight | slight | minimal | minimal | slight | minimal | slight |
Hyperkeratosis | slight | slight | moderate | moderate | moderate | moderate | moderate | moderate | moderate | moderate |
Exocytosis | - | - | - | - | minimal (focal) | minimal (focal) (1) | - | - | - | - |
Spongiosis | - | - | - | - | minimal (basal) | slight (focal) | - | - | - | - |
scab(s) | - | - | - | - | - | - | - | - | - | present |
DERMIS | ||||||||||
Mononuclear cell infiltration | minimal | minimal | minimal | slight | slight | slight | slight | slight | slight | slight |
Folliculitis | - | - | - | - | - | - | - | minimal (focal) | - | minimal (focal) |
Oedema | - | - | - | - | - | - | - | - | - | - |
(1) with some polymorphs
Male no. 62534 showed on the treated area a minimal focus of spongiosis associated with exocytosis which could be due to cell mediated delayed hypersensitivity. Other changes seen in all animals were consistent with a minimal to slight local irritation due to the technical procedures.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not sensitising
- Executive summary:
METHOD:
The guinea pig maximisation test (GPMT) was chosen as test method used to evaluate skin sensitisation potential. The test was performed according to the OECD Guideline 406 (1992).
RESULTS:
Signs of irritation were noted during induction after application of sodium lauryl sulphate in both groups.
After challenge, the macroscopic and histopathological examinations revealed pathological lesion of delayed hypersensitivity in 1 out of the 20 treated animals. No noticeable cutaneous abnormality was noted in the 10 guinea-pigs examined in the control group.
CONCLUSION:
According to the CLP Regulation (EC n. 1272/2008), a substance is classified as skin sensitiser when in the Guinea pig maximisation test the response of at least 30 % of the animals is considered as positive.
In the present experiment, contrary to what it is possible to read in the concluding statement of the report (hypersensitivity in 1 out of the 20 treated animals), two of the animals tested showed a marked skin reaction, as described in the pathologist's report of the biopsies performed at 48 hours on the treated groups. This different in the evaluation of the effects does not affect the interpretation of the outcomes. The new percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC n. 1272/2008).
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