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EC number: 215-481-4 | CAS number: 1327-53-3
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- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact sensitivity to arsenical compounds
- Author:
- Wahlberg, J.E. and Boman, A.
- Year:
- 1 986
- Bibliographic source:
- Dermatosen 34 (1):10-12
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- , adopted 12-05-1981
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study, published in 1986, has been conducted at a time when the guinea pig maximisation test (GPMT) was also an accepted method. It provides adequate information for the assessment of the skin sensitisation potential of the test item(s).
Test material
- Reference substance name:
- sodium dioxoarsenate and disodium hydrogenarsenate
- IUPAC Name:
- sodium dioxoarsenate and disodium hydrogenarsenate
- Reference substance name:
- 232-070-5 and 231-902-4
- IUPAC Name:
- 232-070-5 and 231-902-4
- Reference substance name:
- 7784-46-5 and 7778-43-0
- IUPAC Name:
- 7784-46-5 and 7778-43-0
- Details on test material:
- - Name of test material: Disodium hydrogen arsenate (pa. Merck AG, Darmstadt, FR Germany)
- Molecular formula (if other than submission substance): Na2HAsO4 * 7 H2O
- Name of test material: Sodium-meta-arsenite (pa. Merck AG, Darmstadt, FR Germany)
- Molecular formula (if other than submission substance): NaAsO2
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: distilled water (induction) and saline (challenge)
- Concentration / amount:
- Induction:
Na2HAsO4
- intradermal injection: 4% (w/w)
- topical application: 20% (w/w)
NaAsO2
- intradermal injection: 0.2% (w/w)
- topical application: 0.5% (w/w)
Challenge:
Na2HAsO4: 1.0, 0.5 and 0.1% solutions in saline
NaAsO2: 0.1, 0.05 and 0.01% solutions in saline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water (induction) and saline (challenge)
- Concentration / amount:
- Induction:
Na2HAsO4
- intradermal injection: 4% (w/w)
- topical application: 20% (w/w)
NaAsO2
- intradermal injection: 0.2% (w/w)
- topical application: 0.5% (w/w)
Challenge:
Na2HAsO4: 1.0, 0.5 and 0.1% solutions in saline
NaAsO2: 0.1, 0.05 and 0.01% solutions in saline
- No. of animals per dose:
- 20 animals
- Details on study design:
- Guinea pigs were exposed in groups of 20 animals to Na2HAsO4 and NaAsO2 according to the GPMT method under conditions previously reported (J.E. Wahlberg & A. Boman (1978)*; J.E. Wahlberg & A. Boman (1985)**).
MAIN STUDY
A. INDUCTION EXPOSURE
At induction 4% Na2HAsO4 (w/w) was used for intradermal injection and 20% (w/w) - after treatment for 24 h with 10% sodium lauryl sulphate in petrolatum - for topical application. For NaAsO2 0.2% (w/w) was used for intradermal injection and 0.5% (w/w) for topical application. Distilled water was used as vehicle.
B. CHALLENGE EXPOSURE
Challenge testing was performed on day 21 using 1.0, 0.5 and 0.1% solutions of Na2HAsO4 in saline and 0.1, 0.05 and 0.01% solutions of NaAsO2 in saline. Testing for cross reactivity was performed simultaneously.
ATOMIC ABSORPTION SPECTROPHOTOMETRY: the arsenic compounds used for the guinea pig maximisation test (GPMT) were analysed with a Perkin Elmer 303 atomic absorption spectrophotometer in order to identify impurities of other metals (i.e. nickel or cobalt) contributing to the test reactions.
References:
* Wahlberg, J.E., Boman, A. (1978) Sensitization and testing of guinea pigs with cobalt chloride, Contact Dermatitis 4, 128 - 132.
** Wahlberg, J.E., Boman, A. (1985) Guinea pig maximization test in Curr. Probl. Derm. 14, Anderson, K.E., Maibach, H.I. (Eds.), S. Karger, Basel (1985) (in press). - Challenge controls:
- Sham-treated control groups (20 animals per group) were run in each experiment.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0% (w/w) of Na2HAsO4 * 7 H2O
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0% (w/w) of Na2HAsO4 * 7 H2O. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% (w/w) of Na2HAsO4 * 7 H2O
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5% (w/w) of Na2HAsO4 * 7 H2O. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% (w/w) of Na2HAsO4 * 7 H2O
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% (w/w) of Na2HAsO4 * 7 H2O. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0% (w/w) of Na2HAsO4 * 7 H2O
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0% (w/w) of Na2HAsO4 * 7 H2O. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5% (w/w) of Na2HAsO4 * 7 H2O
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5% (w/w) of Na2HAsO4 * 7 H2O. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1% (w/w) of Na2HAsO4 * 7 H2O
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1% (w/w) of Na2HAsO4 * 7 H2O. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% (w/w) of NaAsO2
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% (w/w) of NaAsO2. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05% (w/w) of NaAsO2
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05% (w/w) of NaAsO2. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01% (w/w) of NaAsO2
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.01% (w/w) of NaAsO2. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1% (w/w) of NaAsO2
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1% (w/w) of NaAsO2. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05% (w/w) of NaAsO2
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.05% (w/w) of NaAsO2. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.01% (w/w) of NaAsO2
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.01% (w/w) of NaAsO2. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: no positive control used in study
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: no positive control used in study
Any other information on results incl. tables
Atomic absorption spectrophotometry
NaAsO2 contained 0.3 ppm cobalt and less than 0.2 ppm nickel and NaHAsO4 less than 0.2 ppm nickel and cobalt.
GMPT Test results:
No statistically significant difference between the exposed and the control groups was seen. There was no evidence of cross-reactivity.
Reading |
Hours after challenge |
Group |
Dose level |
No. with + reactions |
Total no. in group |
Cliinical observations |
1streading |
24 |
test group |
1.0% (w/w) of Na2HAsO4 * 7 H2O |
2 |
19 |
|
2ndreading |
48 |
test group |
1.0% (w/w) of Na2HAsO4 * 7 H2O |
0 |
19 |
|
1streading |
24 |
test group |
0.5% (w/w) of Na2HAsO4 * 7 H2O |
0 |
19 |
|
2ndreading |
48 |
test group |
0.5% (w/w) of Na2HAsO4 * 7 H2O |
0 |
19 |
|
1streading |
24 |
test group |
0.1% (w/w) of Na2HAsO4 * 7 H2O |
0 |
19 |
|
2ndreading |
48 |
test group |
0.1% (w/w) of Na2HAsO4 * 7 H2O |
0 |
19 |
|
1streading |
24 |
negative control |
1.0% (w/w) of Na2HAsO4 * 7 H2O |
1 |
20 |
|
2ndreading |
48 |
negative control |
1.0% (w/w) of Na2HAsO4 * 7 H2O |
0 |
20 |
|
1streading |
24 |
negative control |
0.5% (w/w) of Na2HAsO4 * 7 H2O |
0 |
20 |
|
2ndreading |
48 |
negative control |
0.5% (w/w) of Na2HAsO4 * 7 H2O |
0 |
20 |
|
1streading |
24 |
negative control |
0.1% (w/w) of Na2HAsO4 * 7 H2O |
0 |
20 |
|
2ndreading |
48 |
negative control |
0.1% (w/w) of Na2HAsO4 * 7 H2O |
0 |
20 |
|
1streading |
24 |
test group |
0.1% (w/w) of NaAsO2 |
4 |
20 |
|
2ndreading |
48 |
test group |
0.1% (w/w) of NaAsO2 |
0 |
20 |
|
1streading |
24 |
test group |
0.05% (w/w) of NaAsO2 |
0 |
20 |
|
2ndreading |
48 |
test group |
0.05% (w/w) of NaAsO2 |
0 |
20 |
|
1streading |
24 |
test group |
0.01% (w/w) of NaAsO2 |
0 |
20 |
|
2ndreading |
48 |
test group |
0.01% (w/w) of NaAsO2 |
0 |
20 |
|
1streading |
24 |
negative control |
0.1% (w/w) of NaAsO2 |
4 |
20 |
|
2ndreading |
48 |
negative control |
0.1% (w/w) of NaAsO2 |
1 |
20 |
|
1streading |
24 |
negative control |
0.05% (w/w) of NaAsO2 |
0 |
20 |
|
2ndreading |
48 |
negative control |
0.05% (w/w) of NaAsO2 |
0 |
20 |
|
1streading |
24 |
negative control |
0.01% (w/w) of NaAsO2 |
0 |
20 |
|
2ndreading |
48 |
negative control |
0.01% (w/w) of NaAsO2 |
0 |
20 |
Control groups treated with saline showed no reaction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitive predictive test method (GMPT) does not suggest that the studied arsenicals are skin allergens.
According to Regulation (EC) No. 1272/2008 and subsequent regulations, the substance is not classified as a skin sensitiser.
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