Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-897-7 | CAS number: 3271-76-9
- 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:
- 1981/1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- data were already available
Test material
- Reference substance name:
- Anthra[2,1,9-mna]naphth[2,3-h]acridine-5,10,15(16H)-trione
- EC Number:
- 221-897-7
- EC Name:
- Anthra[2,1,9-mna]naphth[2,3-h]acridine-5,10,15(16H)-trione
- Cas Number:
- 3271-76-9
- Molecular formula:
- C31H15NO3
- IUPAC Name:
- anthra[2,1,9-mna]naphth[2,3-h]acridine-5,10,15(16H)-trione
- Test material form:
- solid: particulate/powder
- Details on test material:
- Vat Green 3
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Unit, Imperial Chemical Industries PLC, Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 4 to 7 weeks
- Weight at study initiation: 270 to 450 g
- Housing: The guinea pigs were housed in suspended stainless steel mesh cages (370 mm length X 320 mm width X 200 mm height). The floor and back of each cage were of 12 mm square stainless steel mesh, the sides were of solid stainless steel and the front was of polycarbonate (Makrolon). The animals were housed individually with 2 animals /cage.
- Diet (ad libitum): RGP Guinea pig Diet
- Water (ad libitum): tap water ad libitum via an automatic water system
- Acclimation period: at least one week
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 50 to 60
- Air changes (per hr): 10 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1% / 0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75% / 0.2 - 0.3 mL
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75% and 25% / 0.2 - 0.3 mL
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 20 Number of animals in negative control group: 10
- Details on study design:
- A. INDUCTION EXPOSURE
The hair was removed of an area, approximately 50 mm x 50 mm on a scapular region of each animal and a row of three injections. (0.1 mL each) was made of each side of the mid-line.
The injections were:
- (i) Freund’s complete adjuvant plus distilled water in the ratio 1:1
(ii) A suspension of the test sample indistilled water.
(iii) A suspension of the Test Sample in distilled water, emulsified with freund’s adjuvant.
ONE WEEK later, the scapular area was clipped again and treated with topical application of the Test Sample as a 75 % (w/v) suspension in distilled water.
Approximately 0.2-0.3 mL of the suspension was applied on filter paper, which was held in place by a piece of surgical tape. The tape was covered by a strip of adhesive bandage around which was wrapped once only, self adhesive PVC tape. This occlusive dressing was kept in place for 48 hours.
B. CHALLENGE EXPOSURE
TWO WEEKS after the topical inductions, an area approximately 150 mm x 50mm, on both flanks of each animal was clipped free on hair using veterinary clippers.
Occlusive dressings were prepared.
Approximately 0.2 -0.3 mL of the suspension of the test sample 75% and 25% in distilled water was placed on the filter paper and the dressing was place on the shorn flanks. The dressing was then covered with a strip of adhesive bandage.
After 24 hours, the occlusive dressings were removed, and discarded.
The skin at the site of application was then cleansed of any residual Test Sample by using clean swabs of cotton wool soaked in clean warm tap water and was then dried gently with clean tissue paper.
24 and 48 hours following decontamination, reactions were quantified using a four point scale and the number of positive responses were recorded.
Results and discussion
In vivo (non-LLNA)
Results
- Clinical observations:
- Skin discolouration prevented the evaluation of skin reddening - histopathological evaluation reveled no skin sensitising potential
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Histopathological examination of the skin indicated that the test substance was not sensitive to guinea pig skin
- Executive summary:
The skin sensitising properties of the test substance were assessed using the maximisation test of Magnusson and Kligman (1970).
Thirty Dunkin Hartley albino female guinea pigs, twenty test and test control were used for the test.
Three main procedures were involved; intradermal injection of a 1% suspension of the test sample in distilled water, topical application of a 75% suspension of the test sample in distilled water and challenge with a 75% and 25% suspension of the test sample in distilled water.
The challenge sites were examined twenty-four and forty-eight hours following the removal of the dressings and any erythematous reactions were quantified at those times. In this study however, the skin assessments were impeded due to the staining by the test sample and samples of test control skin of each guinea pig were submitted for histopathological examination.
Following the 25% and 75% challenge, no erythematous reactions could be seen at twenty-four or fourty-eight hours due to the staining of the skin by the sample.
Histopathological examination of the skin indicated that the test substance was not sensitive to guinea pig skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.