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EC number: 234-933-1 | CAS number: 12042-91-0
- 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 irritation: Not irritating (OECD 404, Rel.2, K)
Eye irritation: Not irritating (OECD 405, GLP, Rel. 1, K)
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:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD guideline 404 and GLP conditions not specified.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive 84/449/EEC
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: Individually
- Diet: ad libitum Altromin 2123 rabbit diet
- Water: ad libitum deionized, chlorated water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Remarks:
- 0.9% NaCl solution
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 ml
- Concentration (if solution): 500 mg in 0.3 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Not specified
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Approx. 24 hours prior to the start of the experiment 3 rabbits were depilated in the dorsal region of the trunk with an electric hair clipper on an area of approx. 25 cm2. Only animals with intact skin were used. Each animal was fixed on the prepared skin site with a wound plaster with 2.5 x 2.5 cm. The area was covered with a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining test substance removed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: subjective numerical according to OECD Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritant/corrosive response observed 30 min, 60 min, 24 h, 48h, 72h after removal of the patch.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance Tanfix AL is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
A skin irritation study was performed according to OECD Guideline 404. 500 mg of test substance was applied to the clipped skin in 0.3 ml of physiological saline of three New Zealands White rabbits under a semi-occlusive cover. After a 4-hour exposure period, the remaining test substance was removed with lukewarm tap water. No reactions were observed.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 /0.0 for erythema and 0.0 / 0.0 / 0.0 for edema.
Under the test conditions, the test substance Tanfix AL is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Reference
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:
- 20 November 2001 - 30 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test was conducted according to OECD Test Guideline No. 405, 1987, under GLP Standards, and QA.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 92/69/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: no data
- Weight at study initiation: 2.9 - 3.2 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- At 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 hours and at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed
SCORING SYSTEM: subjective numerical according to OECD Guideline 405 (corneal (opacity and area), iridic and conjunctival irritation (redness/chemosis/discharge)).
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serious-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material Locron P is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
An eye irritation study was performed according to OECD Guideline 405 and in compliance with GLP. One eye of three rabbits each was exposed to 0.1g of the test substance for 24 hours. Observation occurred at 1, 24, 48 and 72 hours. One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serous-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 1.0 / 1.0 / 1.0 for conjunctivae score and 0.0 / 0.0 / 0.0 for chemosis score.
Under the test conditions, the test material Locron P is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Reference
Table 7.3.2 Individual scores
|
1h |
24h |
48h |
72h |
Mean 24/48/72h |
Corneal opacity |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Iris |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Redness |
2 / 2 / 2 |
2 / 2 / 2 |
1 / 1 / 1 |
0 / 0 / 0 |
1 / 1 / 1 |
Chemosis |
3 / 3 / 3 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Discharge |
2 / 2 / 2 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A key study was identified (Hofmann, 1986). In this skin irritation study performed according to OECD Guideline 404, 500 mg of test substance in 0.3 ml of physiological saline was applied to the clipped skin of three New Zealands White rabbits under a semi-occlusive cover. After a 4 -hour exposure period, the remaining test substance was removed with lukewarm tap water. No reactions were observed.
Eye irritation
A key study was identified (Kauffmann, 2001). In this eye irritation study was performed according to OECD Guideline 405 and in compliance with GLP. One eye of three rabbits each was exposed to 100 mg of the test substance for 24 hours. One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serous-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification for skin or eye irritation according to the Regulation (EC) No. 1272/2008.
Self classification:
Skin irritation
Based on the available data no additional self-classification is proposed regarding skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Eye irritation
Based on the available data no additional self-classification is proposed regarding eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Respiratory irritation
No data was available.
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