Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 433-100-1 | 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
Endpoint summary
Administrative data
Description of key information
The test substance (EC: 433-100-1) caused no sensitisation potential in the guinea-pig maximisation test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-11 to 1999-02-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA study was conducted as an in vivo study according to OCED 406 was conducted in 1999, before the first version of the LLNA (OECD 429) was issued in 2002.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: approx. 4-5 weeks
- Weight at study initiation: 300 - 312 g
- Housing: in groups in Terluran - cages on Altromin saw fiber bedding. Max. group size 10 animals
- Diet: ad libitum, Altromin 3122 maintenance diet for guinea pigs, rich in crude fiber, totaily-pathogen-free-TPF
- Water: ad libitum, tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ±3° C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30 - Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Intra-dermal Induction: 0.1 mL of 50 % (v/v) test item homogenised in Oleum helianthi;
Dermal induction: 2 g test item moistened with CMC 1 % - Day(s)/duration:
- epicutaneous: 48 h
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 2 g of the test Item and moistened with CMC 1%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- INTRADERMAL INJECTION:
Three pairs of intradermal injections of 0.1 mL volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of the midline.
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Prepared test item (2000 mg in 8 ml NaCl 0,9%)
Injection 3: Prepared test item at a concentration of 50% (V/V) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Control group : Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: NaCl 0.9%
Injection 3: NaCl 0.9% at a concentration of 50%> (V/V) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.
- Topical Application:
Test and Control Group: Day 6
Approximately twenty-four hours before the topical induction application the test area, after close clipping was painted with 0.5 ml of 10%> sodium lauryl sulfate in vaseline, in order to create a local Irritation.
Test Group Day 7
A patch was fully loaded with the test item (2 g), moistened with CMC 1 %, applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was fully loaded with the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.
B. CHALLENGE EXPOSURE
Test and Control Group : Day 20
A patch loaded with 2 g of the test Item and moistened with CMC 1% was applied to the left flank of the animals and, a patch loaded with the vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours. At the end of the challenge skin was cleaned with the aid of moistened gauze patches. - Challenge controls:
- yes, for details refer to "details on study design"
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: no positive control conducted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance (EC: 433-100-1) caused no sensitisation potential in the guinea-pig maximisation test.
- Executive summary:
The test substance (EC: 433-100-1) was tested for skin sensitising properties in a guinea pig maximisation test according to EU method B.6 and OECD guideline 406. During the induction phase the guinea pigs (10 test group, 5 control group all females, strain: Hsd Poc:DH) were intradermally injected with a suspension of the test substance and, after treatment with sodium lauryl sulfate topically treated with 100 % test substance. After a latency of 14 days - to allow a potential reaction of the immune system - the animals were challenged with the test item on the flank. The sensitization rate after application of the test substance was 0 %. Under the test conditions described below the test item showed no sensitizing properties. No other signs of toxicity were observed. All animals showed normal food intake and weight gain. It was concluded that under the conditions of the present test, the test substance has no sensitisation potential in the guinea-pig maximisation test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance (EC: 433-100-1) was tested for skin sensitising properties in a guinea pig maximisation test according to EU method B.6 and OECD guideline 406. During the induction phase the guinea pigs (10 test group, 5 control group all females, strain: Hsd Poc:DH) were intradermally injected with a suspension of the test substance and, after treatment with sodium lauryl sulfate, topically treated with 100 % test substance. After a latency of 14 days - to allow a potential reaction of the immune system - the animals were challenged with the test item on the flank. The sensitization rate after application of the test substance was 0 %. Under the test conditions described below the test item showed no sensitizing properties. No other signs of toxicity were observed. All animals showed normal food intake and weight gain. It was concluded that under the conditions of the present test, the test substance has no sensitisation potential in the guinea-pig maximisation test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.
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.