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EC number: 258-799-9 | CAS number: 53817-09-7
- 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: with 20 h exposure time erythema grade 1 were observed at animal #1, and erythema grade 0 were observed at animal #2 (max. grade 4) after 24 h; effects fully reversible within 8 days.
Eye irritation: conjunctivae score 2 (max. grade 4) was observed for both test animals; effects fully reversible within 8 days.
Not to be classified as skin or eye irritating.
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:
- 1976-04-28 to 1977-06-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable study report
- Qualifier:
- according to guideline
- Guideline:
- other: BASF-internal standard
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: animal #1 3.07 kg, animal #2 3.22 kg
- Diet: Ssniff
IN-LIFE DATES: From: 1976-03-24 To: 1976-05-06 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 1 g
- Concentration (if solution): 50% aqueous test substance preparation - Duration of treatment / exposure:
- 20 h
- Observation period:
- 8 d
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: ear 2,5 cm x 2.5 cm; back area not specified, according to study report "application by a cotton ball"
- Type of wrap if used: ear: cotton lobes; back: cotton ball
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was washed off
- Time after start of exposure: after 20 h
SCORING SYSTEM:
Observed effects: observed were the parameters erythema, edema, scaling, and necrosis
Grading system for redness and edema: The data reported have to be converted into presently used numerical grading system as given in the following table
"reizlos" (no symptom) Ø, "fraglich" (questionable) (+): considered as equivalent to grade 0 (no irritating effect) according to OECD Draize scheme
"leicht" (slight) +: considered as equivalent to grade 1 (very slight effect) according to OECD Draize scheme
"stark" (marked) ++: considered as equivalent to grade 2 (well-defined effect) effect according to OECD Draize scheme
"sehr stark" (severe) +++: considered as equivalent to grade ≥3 (severe effect) according to OECD Draize scheme - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: application to back
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: application to back
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: application to back
- Irritant / corrosive response data:
- Application to back for 20 h resulted in grade 1 erythema after 24 h for one of the two test animals, effects observed to be fully reversible on day 8 (other animal without effect).
Application to ear without observed effects at any point in time. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Table of results (20 h application to back) based on grading system as applied in the study report
time |
animal 1 |
animal 2 |
|
erythema |
24 h |
+ |
(+) |
8 d |
Ø |
Ø |
|
edema |
24 h |
Ø |
Ø |
8 d |
Ø |
Ø |
|
scaling |
24 h |
Ø |
Ø |
8 d |
Ø |
Ø |
Table of results (20 h application to back) translated into the grading system as applied by the Draize scheme
time |
animal 1 |
animal 2 |
|
erythema |
24 h |
1 |
0 |
8 d |
0 |
0 |
|
edema |
24 h |
0 |
0 |
8 d |
0 |
0 |
|
scaling |
24 h |
0 |
0 |
8 d |
0 |
0 |
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:
- 1976-04-28 to 1977-06-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable study report
- Qualifier:
- according to guideline
- Guideline:
- other: BASF-internal standard
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: animal #1 2.99 kg, animal #2 2.82 kg
- Diet: Ssniff
IN-LIFE DATES: From: 1976-03-24 To: 1976-04-01 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of test animal treated was with talcum powder
- Amount / concentration applied:
- about 50 mm3, i.e. ca. 50 mg
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was not washed out
SCORING SYSTEM: observed were the parameters redness and chemosis of conjunctivae, and corneal opacity
Grading system for redness and edema: The data reported have to be converted into presently used numerical grading system as given in the following table
"reizlos" (no symptom) Ø, "fraglich" (questionable) (+): considered as equivalent to grade 0 (no irritating effect) according to OECD Draize scheme
"leicht" (slight) +: considered as equivalent to grade 1 (very slight effect) according to OECD Draize scheme
"stark" (marked) ++: considered as equivalent to grade 2 (well-defined effect) effect according to OECD Draize scheme
"sehr stark" (severe) +++: considered as equivalent to grade ≥3 (severe effect) according to OECD Draize scheme
Grading system for iritis: iritis + or ++ equals Draize scheme grade 1 or 2, respectively.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: in addition a "smeary layer" was reported at 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Test item treatment: Slight conjunctival redness was observed at both test animals after 1 h and after 24 h; effects observed to be fully reversible after 8 d.
Control eye treatment with talcum: Control eye of both animals showed slight conjunctival redness after 1 h and after 24 h such as the eye treated with test item; effects also observed to be fully reversible after 8 d. Both control eyes furthermore showed edema after 1 h, grade 3 for animal #1 and grade 2 for animal #2. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Table of results based on grading system as applied in the study report
time |
animal 1 |
animal 2 |
|
conjunctivae |
1 h |
+ |
+ |
24 h |
+ |
+ |
|
8 d |
Ø |
Ø |
|
chemosis |
1 h |
Ø |
Ø |
24 h |
Ø |
Ø |
|
8 d |
Ø |
Ø |
|
cornea |
1 h |
Ø |
Ø |
24 h |
Ø |
Ø |
|
8 d |
Ø |
Ø |
Table of results based on grading system as applied by the Draize scheme
time |
animal 1 |
animal 2 |
|
conjunctivae |
1 h |
1 |
1 |
24 h |
1 |
1 |
|
8 d |
0 |
0 |
|
chemosis |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
8 d |
0 |
0 |
|
cornea |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
8 d |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
The skin irritation was tested in 1977 by a study according to BASF internal standard. The test substance was applied in a single dose (occlusive) to the clipped skin (back and ear) of an experimental animal for 20 h (test item was washed off); untreated skin areas of the test animal served as the control. The degree of irritation was read and scored at 1 min, 5 min, and 15 min, 24 h and 8 days. With 20 h exposure time erythema grade 1 was observed for animal #1, and erythema grade 0 was observed for animal #2 (max. grade 4) after 24 h. These effects were observed to be fully reversible within 8 days.
Eye irritation:
The eye irritation was tested in 1977 by a study according to BASF internal standard. The test substance was applied in a single dose to one of the eyes of the two experimental animals; the other eye treated with talcum served as the control, respectively. The degree of eye irritation (conjunctival redness and chemosis, corneal opacity) was evaluated by scoring lesions of conjunctiva and cornea at 24 h and 8 days. A slight reddening of the conjunctivae (grade 1) was observed at both test animals after 24 h. The effect proved to be fully reversible within the 8 days observation period.
Justification for selection of skin irritation / corrosion endpoint:
Scientifically acceptable study report
Justification for selection of eye irritation endpoint:
Scientifically acceptable study report
Justification for classification or non-classification
Skin irritation
Dangerous Substance Directive
(67/548/EEC)
The available studies are considered reliable and suitable for
classification purposes under Directive 67/548/EEC. As a result the
substance is not considered to be classified for skin irritation under
Directive 67/548/EEC, as amended for the 31st time in Directive
2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The reported effects were less severe than the classification criteria as set out in EC Regulation 1272/2008 (mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 h after patch removal). The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
Eye irritation
Dangerous Substance Directive
(67/548/EEC)
The available studies are considered reliable and
suitable for classification purposes under Directive 67/548/EEC. As
a result and according to the harmonised Annex I classification the
substance is not considered to be classified for eye irritation under
Directive 67/548/EEC, as amended for the 31st time in Directive
2009/2/EG.
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The reported effects were less severe than the minimum
classification criteria for conjunctival redness >=2 as set out in EC
Regulation 1272/2008. No further eye irritating effect observed. The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. As a result
the substance is considered not to be classified for eye irritation.
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