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EC number: 932-164-2 | 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:
- From 26 November 1998 to 21 December 1998
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid skin sensitisation test according to Magnusson & Kligman conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Details on test material:
- - Physical state:yellow clear liquid
- Stability under test conditions: no data on stability were available to LPT
- Storage condition of test material: at 20ºC to 30ºC
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 32 days
- Weight at study initiation: 238-303 g
- Housing: kept in pairs in MAKROLON cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3ºC
- Humidity (%): 60±20%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesame oil DAB
- Concentration / amount:
- intracutaneous injection: 0.001, 0.01, 0.1, 1, 2 and 5%
topical application: 0.2, 2, 10, 20, 50 and 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil DAB
- Concentration / amount:
- intracutaneous injection: 0.001, 0.01, 0.1, 1, 2 and 5%
topical application: 0.2, 2, 10, 20, 50 and 100%
- No. of animals per dose:
- 15 animals
- Details on study design:
- MAIN STUDY
Possible sensitising properties of the test compound were evaluated by administration of the test substance to the shoulder region, first by intracutaneous application (stage 1) and 7 days later by topical administration (stage 2, exposure time: 48 hours).
In a challenge test (stage 3) the test compound was again applied topically but to the flank region (exposure time: 24 hours). This area was then examined for reactions which might indicate sensitising properties to the test compound.
A. INDUCTION EXPOSURE
- Concentrations: Stage 1: Intracutaneous: 0.2%
Stage 2: topical: 10%
Stage 3: topical 0.01%
B. CHALLENGE EXPOSURE
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Concentrations: 2 mL in left flank
2 ml in right flank
Erythema and eschar formation
no erythem: 0
slight erythema: 1
well-defined erythema: 2
moderate erythema: 3
severe erythema to slight eschar formation: 4
Maximum possible: 4
Oedema formation
no oedema: 0
slight oedema: 1
well-defined oedema: 2
moderate oedema: 3
severe oedema: 4
Maximum possible: 4 - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Animals of this strain treated with potassium dichromate exhibited a sensitising reaction.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- 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:
- 0 %
- No. with + reactions:
- 0
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The total number of animals in the negative group is not specified
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- 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:
- 0 %
- No. with + reactions:
- 0
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The total number of animals in the negative control group is not specified
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- not applicable
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Number of animals in the positive control group as well as concentration of the reference susbtance not applicable
Any other information on results incl. tables
Concentration of Product (%) | Route of Administration | Animal no. | Hours after start of treatment | ||
24 h | 48 h | 72 h | |||
5 | intracutaneous | 7 | E3 | E1 | E1 |
2 | 7 | E3 | E1 | E1 | |
1 | 7 | E1 | E1 | E1 | |
0,1 | 8 | E1 | E1 | 0 | |
0,01 | 8 | 0 | 0 | 0 | |
0,001 | 8 | 0 | 0 | 0 | |
non-depilated | topical | ||||
100 | 1 | - | E2 | E3# | |
50 | 1 | - | E2 | E2 | |
20 | 2 | - | E1 | E1 | |
10 | 2 | - | E1 | E1 | |
2 | 3 | - | E1 | 0 | |
0,2 | 3 | - | 0 | 0 | |
depilated | topical | ||||
100 | 4 | E1 | E2 | E3-4## | |
50 | 4 | E1 | E2 | E3-4## | |
20 | 5 | 0 | E2 | E3 | |
10 | 5 | 0 | E2 | E2 | |
2 | 6 | 0 | E1 | E1 | |
0,2 | 6 | 0 | E1 | E1 | |
0,1 | 9 | 0 | E1 | E1 | |
0,01 | 9 | 0 | 0 | 0 | |
0,001 | 10 | 0 | 0 | 0 | |
0,0001 | 10 | 0 | 0 | 0 |
#: laceration, necrosis
##: eschar formation, laceration, necrosis
E1: slight erythema
E2: well-defined erythema
E3: moderate to severe erythema
0: no pathological findings
-: not examined, 48 -h exposure/no values available
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The product did not show any sensitising properties in guinea-pigs in a test model according to MAGNUSSON AND KLIGMAN.
- Executive summary:
The purpose of this study was to determine the potencial of the product to provoke skin sensitisation reactions in guinea-pigs in a test model according to MAGNUSSON and KLIGMAN.
0.1 mL/animal (as a 0.2% concentration in sesame oil) chosen for the 1st (intracutaneous) induction stage and 2 ml/animal (as a 10% concentration in sesame oil) chosen for induction stage 2 (topical) produced a slight irritation in all animals. The challenge with 2 ml/animal (as a 0.01% concentration in sesame oil) revealed no sensitising properties.
The vehicle control animals treated with sesame oil in the same way during stages 1 and 2 and 2 ml of the product during the third stage also revealed no skin reactions.
Behaviour remained unchanged, body weight gain was within the normal range.
Under the present test conditions the product revealed no sensitising properties in guinea-pigs in a test according to MAGNUSSON and KLIGMAN.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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