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EC number: 463-270-2 | 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:
- 2000-02-04 - 2000-06-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The GLP-study was performed according to an internationally accepted guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Twenty-one male albino Dunkin Hartley guinea pigs supplied by David Hall Limited, Burton-on-Trent, Staffordshire, UK were used. At the start of the main study the animals weighed 351 to 426g, and were approximately eight to twelve weeks old. After an acclimatisation period of at least five days, each animal was selected at random and given a number unique within the study which was written on a small area of clipped rump using a black indelible marker-pen.
The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes. Free access to mains tap water and food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed -throughout the study.
The temperature and relative humidity were set to achieve limits of 1 7 to 23 °C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction:
The injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 1 % w/w formulation of the test material in arachis oil BP
c) a 1% w/w formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. A filter paper patch (WHATMAN No.4: approximate size 40 mm x 20 mm), loaded with the undiluted test material as a thick, even layer was applied to the prepared skin and held in place with a strip of surgical adhesive tape covered with an overlapping length of aluminium foil.
Challenge:
A square filter paper patch (WHATMAN No.4: approximate size 20 mm x 20 mm), loaded with the undiluted test material as a thick, even layer was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% w/w in arachis oil BP was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Induction:
The injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 1 % w/w formulation of the test material in arachis oil BP
c) a 1% w/w formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water.
One week later (Day 7), the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. A filter paper patch (WHATMAN No.4: approximate size 40 mm x 20 mm), loaded with the undiluted test material as a thick, even layer was applied to the prepared skin and held in place with a strip of surgical adhesive tape covered with an overlapping length of aluminium foil.
Challenge:
A square filter paper patch (WHATMAN No.4: approximate size 20 mm x 20 mm), loaded with the undiluted test material as a thick, even layer was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% w/w in arachis oil BP was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
CHALLENGE CONCENTRATIONS: UNDILUTED AS SUPPLIED AND 75% w/w
Skin Reactions (Hours After Removal of Dressing) |
||||||||||
Animal |
|
|
24 Hours |
|
|
|
|
48 Hours |
|
|
Number |
|
75% |
|
100% |
|
|
75% |
|
100% |
|
|
Er |
Oe |
Other Er |
Oe |
Other |
Er |
Oe |
Other Er |
Oe |
Other |
1 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
2 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
3 |
* |
* |
* * |
* |
* |
* |
* |
* * |
* |
* |
4 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
5 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
6 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
7 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
8 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
9 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
10 |
0 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
0 |
- |
Er = erythema Oe = oedema - = no other reactions noted * = no data; animal killed for humane reasons Day 17 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, YOFCO MAS LOT NO. 92506, produced a 0% (0/9) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 96/54/EC (which constitutes Annex V of Council Directive 67/548/EEC).
Ten test and five control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction : 1% w/w in arachis oil BP
Topical Induction : undiluted as supplied
Topical Challenge : undiluted as supplied and 75% w/w in arachis oil BP
The test material produced a 0% (0/9) sensitisation rate and was classified as a non sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations. No symbol and risk phrase are required.
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