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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-607-8 | CAS number: 1333-82-0
- 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 potential of Cr(VI) was shown in guinea pigs testing potassium dichromate. There is also evidence of cross-reactivity between Cr(VI and Cr(III) compounds.
No in vitro data or animal data on respriatory sensitisation are avaialble for Cr(VI) compounds. However it was conculded that Cr(VI) compounds have the potential to cause respiratory sensitisation in exposed humans (please refer to 7.10.4)
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The sensitization was done in the following manner: 5 injections of 0.2 ml each of emulsion containing either 1 mg/ ml of potassium dichromate (Merck, Darmstadt, FRG) in Freund's complete adjuvant (FCA) (DIFCO Laboratories, Detroit, Michigan) or 2 mg/ml of chromium chloride (Merck, Darmstadt, FRG) in FCA were given into the footpad and nape of the neck. Animals were restimulated once a week by an intradermal injection of 25 µg either of potassium dichromate or chromium chloride in 0.1 ml 0.15 M NaCl solution into the skin of the right flank. Simultaneously 0.02 ml of either 0.5% potassium dichromate or chromium chloride solution in 1 % Triton X-100 were applied epicutaneously on the skin of the left flank. The boosting was continued weekly until a positive reaction to the hapten was observed. The animals were then challenged epicutaneously with both haptens and the skin inflammation evaluated 24 hr later according to an arbitrary scale: red, swollen = 2, red, contluent = 1, red spots = 0.5.
- GLP compliance:
- not specified
- Remarks:
- published study
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- available data, published before LLNA declared as gold standard
- Specific details on test material used for the study:
- potassium dichromate (Merck, Darmstadt, FRG)
- Species:
- guinea pig
- Strain:
- other: Rockefeller
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Inbred strain 2 and partially inbred strain Rockefeller guinea pigs of either sex were used. They weighed about 350- 400 g when sensitization was begun. The animals were bred at the Institute for Biochemical Research, Füllinsdorf, Switzerland. They were fed on pellet diet supplemented ad libitum with water containing vitamin C.
- Route:
- intradermal
- Vehicle:
- other: Freund's adjuvant (FCA)
- Concentration / amount:
- 5 injections of 0.2 ml each of emulsion containing either 1 mg/ ml of potassium dichromate in Freund's complete adjuvant (FCA)
- Day(s)/duration:
- not specified
- Adequacy of induction:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal: 0.1 ml 0.15 M NaCl solution; epicutaneously: 1% Tritox X-100
- Concentration / amount:
- intradermal: 25 µg potassium dichromate in NaCl solution; epicutaneously: 0.02 ml of 0.5% potassium dichromate in Triton X-100
- Day(s)/duration:
- once a week for 4-6 weeks until positive reaction occured
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: epicutaneously
- Vehicle:
- not specified
- Concentration / amount:
- not specified
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 11 animals
- Details on study design:
- see above
- Challenge controls:
- not specified
- Positive control substance(s):
- no
- Positive control results:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- not specified
- No. with + reactions:
- 11
- Total no. in group:
- 11
- Remarks on result:
- positive indication of skin sensitisation
- Conclusions:
- Guinea pigs sensitized with either the trivalent chromium chloride or the hexavalent potassium dichromate are capable of reacting in vivo and in vitro to challenges with both chromium salts. This double reactivity is retained also after repeated restimulations with only 1 of these chromium compounds.
- Executive summary:
The results of this study show that Cr (VI) tested as potassium dichromate is able to induce skin sensitisation in guinea pigs. Also, there is evidence of cross-reactivity between Cr(VI) and Cr(III) compounds. The experiments in guinea pigs showed that animals which were sensitised to Cr(VI) compounds produced a positive skin response when challenged with Cr(III) compounds, and that animals sensitised to Cr(III) give a positive skin response when challenged with Cr(VI).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Remarks:
- study predates GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- available data, published before LLNA declared as gold standard
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Albino guinea pigs weighing 300-500 grams are used. While susceptibility is not influenced by sex, we prefer females because of their greater tractability. The combativeness of males often damages the test sites. Pregnant animals are entirely unsuitable because of decreased capacity to manifest an inflammatory reaction.
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: adjuvant or petrolatum
- Remarks:
- see 'any other information on materials and methods' for further details on induction procedure
- Concentration / amount:
- 1 %
- Day(s)/duration:
- 21
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 24
- Details on study design:
- see 'any other information on materials and methods'
- Positive control substance(s):
- yes
- Remarks:
- eleven known allergens were tested, including Mercaptobenzothiazole
- Positive control results:
- Eleven known allergens (Benzocaine, Malathion, Mercaptobenzothiazole, mercuric chloride, monobenzyl ether of hydroquinone, neomycin, nickel sulfate, strepromycin, sulfathiazole, turpentine, and Vioform) were used. The Maximization testing readily identified these, a majority of animals usually becoming sensitized.
- Reading:
- other: final result from readings after 24 and 48h
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 18
- Total no. in group:
- 24
- Clinical observations:
- not specified
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: final result from reading after 24 and 48h
- Group:
- negative control
- Dose level:
- 0.5 % SLS
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: final result from reading after 24 and 48h
- Group:
- positive control
- Dose level:
- 15 % Mercaptobenzothiazole
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- not specified
- Remarks on result:
- positive indication of skin sensitisation
- Conclusions:
- Potassium dichromate was shown to be sensitising in the guinea pig maximization test
- Executive summary:
The results of this study show that Cr (VI) tested as potassium dichromate is able to induce skin sensitisation in the guinea pig maximization test.
Referenceopen allclose all
All guinea pigs sensitized with potassium dichromate in FCA and boosted several times epicutaneously and intradermaliy with the same hapten responded after 4-6 weeks to an epicutaneous challenge with this hexavalent chromium salt.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The following information is taken from the EU RAR:
'Skin sensitisation resulting from occupational contact with Cr(VI) compounds is relatively common in humans. This has also been demonstrated in patch testing of contact dermatitis patients and in investigations of various occupational groups. In addition, the skin sensitisation potential of Cr (VI) compounds has been clearly demonstrated in standard and modified guinea pig maximisation tests and in the mouse ear swelling test. The current understanding of the mechanism involved in the sensitisation indicates that Cr (III) is the ultimate hapten. Skin contact with Cr (VI) leads to penetration of Cr (VI) into the skin where it is reduced to Cr (III). There is some evidence for cross-reactivity between Cr (III) and Cr (VI); Cr(VI)-sensitised subjects may also react to Cr (III). Overall, it is not possible to reliably determine a threshold for either induction or challenge in an exposed population using the available data, however it is assumed that all water soluble Cr (VI) compounds are human skin sensitisers.'
Conclusively, skin sensitisation potential of Cr(VI) was shown in animals testing Cr(VI) compounds, e.g. potassium dichromate. There is also evidence of cross-reactivity between Cr(VI and Cr(III) compounds.
Besides several positive animal studies available data from human exposure indicate that water-soluble Cr(VI) compounds are skin sensitisers. Therefore, further testing of this group of compounds for skin sensitisation is not proposed, also based on the low pH and classification as corrosive.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No suitable animal tests are available for the detection of respiratory sensitisation. The EU RAR discusses reports of occupational asthma in workers exposed to Cr(VI) compounds:
'Asthma arising from exposure to Cr(VI) was first suggested in the 19th century. A number of case reports, mainly within the chrome plating industry, provide evidence that inhaled Cr (VI) can cause asthma, although the total number of reported cases is small in relation to the number of workers potentially exposed. Positive findings are available from several well-conducted bronchial challenge tests. No information is available on the dose-response relationships for induction of the hypersensitive state or elicitation of an asthmatic response in hypersensitive individuals. The available case reports and evidence from well-conducted bronchial challenge tests, show that inhalation of Cr (VI) compounds can cause occupational asthma. As with skin, Cr (VI)- sensitised subjects may react to Cr (III). It is not possible to determine a no-effect level or exposure-response relationship for induction or elicitation of occupational asthma.'
It is therefore concluded that chromic acid (as other Cr(VI) compounds) has the potential to cause respiratory sensitisation in exposed humans and should be classified.
Justification for classification or non-classification
Chromium (VI) trioxide, sodium chromate, sodium dichromate and potassium dichromate are classified under Annex I to directive 67/548/EEC. Chromium (VI) trioxide is listed in Annex VI to Regulation (EC) No 1272/2008 under Index No 024-001-00-0 with the following harmonised classification:
Skin Sens. 1, H317 ‘May cause an allergic skin reaction’ and Resp. Sens. 1, H334 ‘May cause allergy or asthma symptoms or breathing difficulties if inhaled’
No change to this classification is proposed.
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.