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EC number: 422-460-5 | CAS number: 137234-87-8 UK-103,442
- 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
Skin sensitisation:
This study was performed to assess the skin sensitisation potential of test item using the guinea pig following the method as described in EC B.6.
In this study, the test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
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:
- From 1996-05-29 to 1996-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- OJ No. L383A, 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Testing performed in the nineties, and conducted in accordance with the test methods laid down in EC and in compliance with the principles of good laboratory practice of EC, OECD, etc.
- Specific details on test material used for the study:
- Batch No.: 950704
Purity: 95.7% - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England.
- Age at study initiation: Ca. five to six weeks
- Weight at study initiation: 357-427 g
- Housing: housed in groups of five in suspended metal cages with wire mesh floors
- Diet: vitamin C enriched guinea-pig diet FD2, ad libitum; Hay was given weekly.
- Water: ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15 air changes per hour approximately
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period. - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 2.5% w/v
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- other: Topical, otherwise unspecified
- Vehicle:
- water
- Concentration / amount:
- 70% w/v
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- other: Topical, not specified
- Vehicle:
- water
- Concentration / amount:
- 70% w/v
- Day(s)/duration:
- Day 22 / 24h
- No.:
- #2
- Route:
- other: Topical, not specified
- Vehicle:
- water
- Concentration / amount:
- 35% w/v
- Day(s)/duration:
- Day 22 / 24 h
- No. of animals per dose:
- Test: 10
Control: 5 - Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- 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. Three pairs of intradermal injections were made into a 20 X 40 mm area within the clipped area.
Injectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (Ph.Eur.).
2.test item, 2.5% w/v in water for irrigation.
3. test item, 2.5% w/v in a 50 : 50 mixture of Freund's complete adjuvant and water for irrigation.
- Induction topical application - test animals:
Six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.5 mL per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 x 40 mm patch of Whatman No. 3 paper was saturated with approximately 0.4 mL of test item, 70% w/v in distilled water. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
- Induction - control animals: Treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: two weeks after the töpical induction
- Exposure period: 24 h
- Test and control groups: 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-103,442, 70% w/v in distilled water and applied to an anterior site on the flank. The test item, 35% w/v in distilled water was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours under strips of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek".
- Concentrations: 70 and 35% w/v in distilled water
- Evaluation: 24 and 48 hours after removal of the patches
OTHER:
- Clinical signs: All animals were observed daily for signs of ill health or toxicity.
- Bodyweight: recorded on Day 1 (day of intradermal injections) and on the last day observations were made of dermal responses to the challenge applications. - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the guinea-pig strain used is checked periodically at lab with hexyl cinnamic aldehyde, a known sensitiser.
- Positive control results:
- 10/10 animal give positive result at the most recently test.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 35 and 70% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity recorded
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 35 and 70% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity recorded
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 35 and 70% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 35 and 70% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: Not specified
- Group:
- positive control
- Dose level:
- As supplied and 50 % v/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
- Executive summary:
This study was performed to assess the skin sensitisation potential of test item using the guinea pig following the method as described in EC B.6. Ten test and five control guinea-pigs were used in this study. The dose levels selected was 2.5 %w/v in water for Intradermal injection, 70% w/v in distilled water for Topical application, 70 and 35% w/v in distilled water for Challenge application.
In this study, the test item did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
Reference
- Bodyweight:
Bodyweight increases were recorded for all guinea-pigs over the period of the study.
INDUCTION
-Intradermal injections:
Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals.
Slight irritation was seen in test animals at sites receiving test item, 2.5% w/v in water for irrigation and no irritation was observed in control animals receiving water for irrigation.
- Topical application:
Moderate erythema was observed in test animals following topical application with test item, 70% w/v in distilled water. Slight erythema was seen in the control guinea-pigs.
CHALLENGE
There were no dermal reactions seen in any of the test or control animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Respiratory sensitisation:
Data lacking.
Skin sensitisation:
skin sensitisation in guinea-pig, EC B.6: negative, 0/10 show positive response.
Therefore in accordance with Regulation (EC) No. 1272/2008 (as amended by Regulation (EC) No. 286/2011) Table 3.4.2 and section 3.4.2.2.4.1., the substance should not be classified for this endpoint.
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