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EC number: 231-984-1 | CAS number: 7783-20-2
- 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 irritation
In a primary dermal irritation study (BASF
1969), an 80% aqueous suspension of the test substance (chemically pure;
purity not further specified) was not irritating when applied to the
dorsal skin of rabbits for up to 20 hours under occlusive conditions.
This treatment caused only slight, barely visible skin erythema
(equivalent to a Draize score of 0) at 24 hours. No other signs of
irritation were observed.
In a comparative study on dermal irritation with 12 different lots of
the test substance (purity not stated) (BASF 1968), the test substance
was not irritating to the intact skin of the white rabbit when applied
as a single dose (20 hours) or as a repeated dose (5 x 8 hours). In
contrast, moderate irritation was observed following repeated
application (5 x 8 hours) to the abraded skin. These effects were
completely reversible within 8 days.
Eye irritation
In a primary irritation study (BASF 1969), 50 µl of the unchanged test substance (chemically pure; purity not further specified) was instilled into one eye of each of 2 rabbits. Talkum was placed into the adjacent eye for control purpose. The unchanged test substance produced slight irritation to the eye. The effects observed were similar to those observed with the control compound, talkum. Slight edema and conjunctival redness was noted at 1 hour after instillation of the test substance; no edema, but still slight redness was present at 24 hours. In the eyes treated with talcum, slight redness was also noted at 1 and 24 hours after exposure. No effects were noted at day 8.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation, application time not according to OECD TG 404. The test results from the ear are not taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back.
- Principles of method if other than guideline:
- BASF Test
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 80% - Duration of treatment / exposure:
- up to 20 hours (back)
- Observation period:
- 8 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: back
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at the end of the respective application period
SCORING SYSTEM:
BASF scoring system, convertible to Draize score system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: 20 h exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 20 h exposure
- Irritant / corrosive response data:
- Barely visible skin erythema (equivalent to a Draize score of 0) was noted at 24 hours after exposure when test substance was applied for 5 minutes, 15 minutes or 20 hours. No effects were noted at 8 days after the end of the exposure or after exposure to the test substance for only 1 minute. Neither scaling nor edema were noted at any observation time.
- Other effects:
- No mortality occurred and there were no clinical signs of toxicity observed.
Reference
Table: Draize scores
Application site |
Application time |
Findings at |
||
24 hours |
8 days |
|||
Erythema |
edema |
|||
Back |
1 min |
no findings |
no findings |
|
5 min |
1 |
0 |
no findings |
|
15 min |
1 |
0 |
no findings |
|
20 h |
1 |
0 |
no findings |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talkum was placed into the other eye of the test animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied 50 µl bulk volume - Duration of treatment / exposure:
- instillation without rinsing
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no
SCORING SYSTEM:
BASF scoring system, convertible to Draize score system - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 , 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Slight edema and conjunctival redness was noted at 1 hour after instillation of the test substance; no edema, but still slight redness was present at 24 hours. In the eyes treated with talcum, slight redness was also noted at 1 and 24 hours after exposure. No effects were noted at day 8.
Reference
Table: Draize scores
Reading |
Test substance unchanged |
Talkum (control) |
||
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
1 |
1 |
0 |
24 h |
1 |
0 |
1 |
0 |
8 d |
No findings |
No findings |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The conditions used in the dermal irritation study (BASF 1969) are not exactly the same as those required by OECD TG 404. However, no irritation was observed in this test (20 -hour occluded exposure), thus it does not appear probable that an irritating result would be obtained under the much milder conditions required by TG 404 (4-hour exposure under semiocclusive conditions). Detailed data on purity are lacking; but as the substance was stated to be "chemically pure" and as there was no irritation, this is thought not to impair the evaluation of the skin irritation potential significantly. A 80% aqueous suspension was tested instead of the unchanged test substance; however, as this is above the limit of solubility, it can be presumed that application of the neat test substance would not produced stronger irritation. This statement can be confirmed by the findings of the second, comparative skin irritation study (BASF 1968) with different lots of ammonium sulphate where the neat compound was applied and did not cause any irritation to the intact skin, even after prolonged exposure.
Eye irritation
Application of the unchanged, solid test substance produced some signs of irritation: slight edema as early as 1 hour after instillation and slight redness at up to 24 hours. However, this slight irritation may also be due to a mechanical impact of the solid which leads to irritation reactions. This assumption is confirmed by the results of the control eye: treatment with talkum produced almost the same signs of irritation as did the test substance. Therefore, signs of irrtation observed with the unchanged test substance are rather due to a physical/mechanical effect than to chemical irritation. Detailed data on purity are lacking; but as the substance was stated to be "chemically pure" and as there was no irritation, this is thought not to impair the evaluation of the eye irritation potential significantly.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The
substance is not considered to be classified for skin or eye irritation
under Regulation (EC) No 1272/2008, as amended for the ninth time in
Regulation (EU) No 2016/1179.
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.
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