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EC number: 423-870-7 | 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
Skin sensitisation: not sensitising (EU method B6; GLP)
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:
- 2001-11-08 to 2001-12-08
- 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:
- 1996-09-30
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2001-08-22
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The conduct of this study was prior to the establishment of the LLNA method (OECD 429).
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored dry - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, D-33178 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: younger than 1 year
- Weight at study initiation: Treatment group: 249 - 286 g and control group: 260 - 290 g
- Housing: housed individually in Makrolon cages (780 cm²)
- Diet: Raiffeisen Ringfutter, Trockenfutter 52 P, Raiffeisen Kraftfuttermischwerk Kehl
- Water: ad libitum, tap water (with addition of 20 mg / L ascorbic acid and 100 mg citric acid per 100 ml water)
- Acclimation period: 5 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Relative humidity: 30 - 70 °C
- Photoperiod (hrs dark / hrs light): 12:12 - Route:
- intradermal
- Concentration / amount:
- 0.1 ml of Freund's Adjuvant (FCA) in aqua ad incietabilia (1:1)
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 0.1 ml 5 % test substance
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- intradermal
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.1 ml 5 % test substance in Freund's Adjuvant (FCA)
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- not specified
- Day(s)/duration:
- Day 7
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 50 % test substance (w/w)
- Day(s)/duration:
- Day 21 (treatment duration: 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (test substance) + 5 (controls)
- Details on study design:
- RANGE FINDING TESTS:
On the basis of two preliminary investigations (each with 3 guinea pigs) the doses for the main study were chosen.
The intradermal irritancy of the test article was investigated in order to find the minimal irritant test article concentration for the intradermal induction using intradermal injections as in the main study. The following test item concentrations were tested as 0,1 ml intradermal injection: 1 %, 3 % and 5 % (w/w) test substance in aqua ad iniectabilia. Observation time points for oedema or erythema were 24, 48 and 72 hours post-exposure.
The topical irritancy of the test article was investigated in order to find the minimal irritant test article concentration for the dermal induction and the maximum non-irritating test article concentration for the challenge application using procedures similar to the main study. The following test item concentrations were tested: 20 %, 33,3 % and 50 % test substance in aqua ad iniectabilia. A filter paper (2x4 cm²) was moistened with the test material and occlusively fixed for 24 hours on the guinea pig's clipped back. Observation time point for oedema or erythema was 24 hours post-exposure.
Results:
intradermal injection: no skin reaction was observed, the 5 % test concentration was determined for intradermal induction in the main study.
topical application: no skin reaction was observed, the test concentration was determined as challenge concentration in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and dermal application)
- Site: area of dorsal skin 4 x 6 cm in the scapular region was clipped free of pair with an electric clipper.
- Frequency of applications: three pairs of intradermal injections were given once and 6 days later the same site was treated with 0.5 ml sodium lauryl sulphate (10% in vasaline) to provoke a mild inflammatory reaction. 24 hours later the test item was topically applied to the skin by using filter paper (moistened with the test item) and a occlusive bandage.
- Concentrations
Test animals:
Intradermal:
i) 0.1 mL FCA diluted 1:1 with aqua ad iniectabilia
ii) 0.1 mL test article in sesame oil (final concentration: 5 % (w/w))
iii) 0.1 mL test article in FCA mixed with aqua ad iniectabilia in the ratio 1:1 (final concentration: 5 % (w/w))
Topical application:
not specified
Control animals:
Intradermal injection:
i) 0.1 mL FCA diluted 1:1 with aqua ad iniectabilia
ii) 0.1 mL sesame oil
iii) 0.1 mL sesame oil and FCA with aqua ad iniectabilia (1:1) in the ratio 1:1 (w/w)
Topical application:
sesame oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (topical application three weeks after the intradermal induction)
- Exposure period: 24 hours
- Site: both flanks clipped (area: 3x5 cm²), right flank: sesame oil; left flank: 50 % of the test item in sesame oil
- Concentrations:
test animals: 50 % test item in aqua ad iniectabilia ((1:1) (w/w))
controls: sesame oil
- Evaluation (hr after challenge): 48 and 72 hours
- Challenge controls:
- 5 guinea pigs were used as control animals.
Challenge dose: right flank: sesame oil; left flank: 50 % of the test item in sesame oil - Positive control substance(s):
- yes
- Positive control results:
- The postive control (benzocaine) has induced in 6 of 10 guinea pigs in the treatment group slight or moderate, diffuse redness 48 hours post-exposure.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % (w/w) test substance in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 % (w/w) test substance in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % (w/w) test substance in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50 % (w/w) test substance in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100 % benzocaine in sesame oil
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 100 % benzocaine in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Regulation (EC) 1272/2008 and subsequent adaptions, the substance is not sensitising to the skin.
Reference
Body weight gain was observed in all tested animals to the end of the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Skin sensitisation
The substance does not possess a skin sensitisation potential and does not require classification as skin sensitiser according to Regulation (EC) No 1272/2008 and subsequent adaptations.
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