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EC number: 424-110-7 | CAS number: 194602-23-8 UK-143,108
- 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:
- 5 August and 5 September 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- The first study was conducted with 5 control and I 0 test animals between 12 September and l3 October 1995 (Huntingdon Lite Sciences repmt No PFZ 681/952756/S S). In this first study two of the ten test animals gave a positive response and the remaining eight animals gave negative responses. It was considered that a further five control and ten test animals should be tested to confirm this negative result. The second study was conducted between 5 August and 5 September 1997
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was done under the NONs program prior to Reach
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- Appearence: Off-white crystalline solid
Expiry : February l 998
Purity: 99.6% excluding organic solvents
Date received : 19 May 1995
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- At the start of the study the animals were in the weight range of 278 to 379 grams and were 4-7 weeks old. Animals were acclimatised for 5 days prior to the study. Free access to mains drinking water and food (vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC))was allowed throughout the study. The temperature and relative humidity were set to achieve limits of 25C and 67% respectively. Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal injections & topical application
- Vehicle:
- water
- Concentration / amount:
- Based on the results of the preliminary investigations. the following concentrations of UK-143- l 08 were
selected:
Induction intradermal injection - 7.5% w/v in water for irrigation
This was the highest concentration that caused irritation but did not adversely affect the animals Induction topical application - 60% w/v in distilled water
Topical challenge - 60 and 30% w/v in distilled \water
Challengeopen allclose all
- Route:
- other: topical application
- Vehicle:
- water
- Concentration / amount:
- Based on the results of the preliminary investigations. the following concentrations of UK-143- l 08 were
selected:
Induction intradermal injection - 7.5% w/v in water for irrigation
This was the highest concentration that caused irritation but did not adversely affect the animals Induction topical application - 60% w/v in distilled water
Topical challenge - 60 and 30% w/v in distilled \water
- No. of animals per dose:
- No Data (20 test animals in total)
- Details on study design:
- Main study
The procedure may be considered in two parts, Induction and Challenge.
1. Induction
Induction intradermal injections - test animals
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers .
injections for the test animals were prepared as follows:
I . Freund, s complete adjuvant** was diluted with an equal volume of water for irrigation(Ph.Eur.) .
2. UK-143J08, 7.5% w/v in water for irrigation.
3. UK-143, 108_ 7.5% w/v in a 50 : 50 of Freund 's compare adjuvarit and water for irrigation.
**Difeo Laboratories . Detroit . Michigan , U.SA.
Challenge - control and test animals
The control and test animals were challenged topically two weeks after the topical induction application using UK- l 43 , 108, 60 and 30% w/v in distilled water.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig A 20 x 20 mm patch of Whatman No . 3 paper was saturated with approximately 0.2 ml of UK-143,108 . 60% w/v in distilled water and applied to an anterior site on the flank UK-
143.l 08, 30% w/v in distilled water was applied in a similar manner to a posterior site. The
patches were scaled to the flank for 24 hours under strips of ''Blenderm" covered by
"Elastoplast ' wound round the trunk and secured with 'Sleek" - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 30
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 30.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 30
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 30.0.
Any other information on results incl. tables
INDUCTION
Intradermal injections
Necrosis was recorded at sites receiving Frcund's Complete Adjuvant in test and control animals.
Slight irritation was seen in test animals at sites receiving UK-143,108, 7.3% wiv in water for irrigation
and no irritation was ohscrved in control animals receiving water for irrigation.
Topical application
Sight enothema was observed ir test. animals following topical application with UK-143,108, 60% w/v
in distilled water.Slight erythema was seen in the control guinea-pigs.
CHALLENGE
There were no dermal reactions seen in eighteen of the twenty test animals or in the control animals, therefore these eighteen test animals gave negative responses. Dermal reactions were observed for two of the test animals, therefore these gave positive responses.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In this study, 11K-143.108 did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in eighteen of the twenty test animals. The remaining two animals gave positive responses.
Overall, evidence of skin sensitisation was seen in 10% of the animals and UK-143,108 is not considered to be a sensitiser.
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