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EC number: 220-985-2 | CAS number: 2958-36-3
- 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:
- 01 Sep - 12 Dec 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The present study pre-dates the requirement for the murine local lymph node assay (LLNA) as the first-choice method for in vivo testing, and thus fulfils the standard information requirements in accordance with Annex VII, Section 8.3 of Regulation (EC) No. 1907/2006.
Test material
- Reference substance name:
- 2-amino-2',5-dichlorobenzophenone
- EC Number:
- 220-985-2
- EC Name:
- 2-amino-2',5-dichlorobenzophenone
- Cas Number:
- 2958-36-3
- Molecular formula:
- C13H9Cl2NO
- IUPAC Name:
- 4-chloro-2-(2-chlorobenzoyl)aniline
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 18 days
- Weight at study initiation: males 323.9 g ± 10.5 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5- 20.5 °C
- Humidity (%): 30 - 65 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 0.5% (w/v) solution of Tylose MH 1000 ("TS") in deionised water
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0 of study
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- (Vaseline)
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 7 of study
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- (Vaseline)
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 21 of study
- Adequacy of challenge:
- other: highest technically applicable concentration used
- No. of animals per dose:
- Control group: 5
Test group: 15 - Details on study design:
- Pilot Study:
The aim of the pilot study was to find out the highest concentrations which cause mild-tomoderate skin irritation after intracutaneous and epicutaneous
administration and the highest non-irritant concentration after epicutaneous administration.
Main study:
Three pairs of intracutaneous injections of 0.1 ml volume were given to each animal in the shoulder region so that one of each pair lies on each side of the
midline in cranial to caudal sequence.
Dose group:
Injection 1: mixture of Aqua pro injectione and FCA (1:1, v/v)
Injection 2: 5 % (w/v) suspension ofthe test item in TS
Injection 3: 5% (w/v) suspension ofthe test item in FCA/ Aqua pro injectione (1 :1, v/v)
Control group:
Injection 1: mixture of Aqua pro injectione and FCA (1: 1, v/v)
Injection 2: TS
Injection 3: 50 % mixture (w/v) of TS in a mixture of Aqua pro injectione and FCA (1: 1, v/v)
Day 7: lnduction by Epicutaneous Administration
Dose group:
One layer of filter paper (2 x 4 cm) was loaded with 0.5 g of the 25 % (w/w) mixture of the test item with vaseline. One patch each was then placed on the skin ofboth sides ofthe body.
Control group:
One layer of filter paper (2 x 4 cm) was loaded with 0.5 g of vaseline. One patch each was then placed on the skin ofboth sides ofthe body.
Day 21: Challenge by Epicutaneous Administration:
Dose and control group:
One strip of gauze patch was loaded with 0.5 g of the 25 % (w/w) mixture of the test item with vaseline and applied to the right flank of all animals.
Other strips of gauze patch were loaded with 0.5 g of vaseline and applied to the left flank of all animals.
All patches were covered with film and held in contact with the skin by occlusive dressing. After 24 hours the patches were removed and the administration areas were cleaned with corn oil.
Days 23 and 24: Assessment of Challenge Reaction
At 24 and 48 hours after patch removal ( 48 and 72 hours after start of challenge) the skin reaction was observed and recorded according to the
MAGNUSSON and KLIGMAN grading
scale - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain of guinea pig (Dunkin Hartley, Crl:(HA)BR) and reliability of the experimental technique used is checked routinely by use of the known mild skin sensitiser Benzocaine.
Results and discussion
- Positive control results:
- Not included in this test. However, strain sensitivity is checked periodically with known sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 and 25% (induction), 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 and 25% (induction), 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Any other information on materials and methods incl. tables
Animal supplier: Charles River Wiga GmbH, D-97320 Sulzfeld
Draize score
Erythema and eschar formation |
Score |
No erythema |
0 |
Very slight erythema (barely preceptible) |
1 |
Well defined erythema |
2 |
Moderate to severe erythema |
3 |
Severe erythema (beet redness) to slight eschar formation (injuries in depth) |
4 |
Edema formation |
Score |
No edema |
0 |
Very slight edema (barely preceptible) |
1 |
Slight edema (edges of area well defined by definite raising) |
2 |
Moderate edema (raised approximately 1 mm) |
3 |
Severe edema (raised more than 1 mm and extending beyond area of exposure) |
4 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the results of this study and in accordance with the criteria of Regulation /EC) 1272/2008, ADB is not a skin sensitiser.
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