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EC number: 217-123-2 | CAS number: 1746-03-8
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- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Environmental data
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- 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
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- 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
The test substance was found to be corrosive to skin and causing irreversible damage to the eyes.
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:
- weight of evidence
- Study period:
- 1992-01-14 to 1992-02-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: T 16/91
- Expiration date of the lot/batch: July 1992
- Purity test date: 1992-05-13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark
- Stability under test conditions: stable - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: about 3-5 months
- Weight at study initiation: 2700-3600 g
- Housing: single
- Diet: Altromin 2123 Haltungsdiat - Kaninchen, Altromin-GmbH (Lage/Lippe, Germany), ad libitum
- Water: deionized, chlorinated water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 3
- Humidity (%): 55+/- 20
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg
- Concentration: ca. 90 %
VEHICLE
- Amount applied: 0,05 mL NaCl (0,9 %) - Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- Observations were caried out 30-60 min and 24, 48, 72 h, 7 days and 14 days after removal of the test substance.
- Number of animals:
- 3 animals (3 min exposure)
1 animal (4 hours exposure) - Details on study design:
- TEST SITE
- Area of exposure: dorsal, about 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with tap water
- Time after start of exposure: 3 min or 4 h
OBSERVATION TIME POINTS
30-60min, 24 h, 48 h, 72 h, 7 days, 14 days
SCORING SYSTEM:
Erythema and edema were scored according to a 5 graded scale. - Irritation parameter:
- erythema score
- Remarks:
- 4 hours exposure
- Basis:
- animal #1
- Remarks:
- only one animal tested
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 4 hours exposure
- Basis:
- animal #1
- Remarks:
- only one animal tested
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 minutes exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 minutes exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 minutes exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 minutes exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 minutes exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 minutes exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of skin irritation were noticed after an exposure period of 3 minutes.
The animal exposed for 4 hours exhibited moderate to severe erythema at the observation time points 30-60 min, 24, 48, 72 h (score 3, respectively). At the observation time points 7 and 14 days the erythema were scored 4 (severe). Therefore, the findings were considered not reversible.
Edema were scored 3, 2, 1 and 1 at the time points 30-60 min, 24 h, 48 h and 72 hours and 1 after 7 and 14 days. - Other effects:
- - Other adverse local effects: The skin appeared discoloured/white after 4 hours exposure. Further effects observed throughout the observation period: encrustation, scaled and dry skin.
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- The test material was shown to be corrosive to skin after an exposure period of 4 hours.
- Executive summary:
The test material was examined for its potential to cause skin irritation/corrosion in New Zealand White rabbits. 500 mg were diluted with 0.05 mL 0.9 % NaCl and applied under semiocclusive dressing. Three animals were exposed for 3 minutes, one animal was exposed for 4 hours. After removal of the patches the test sites were washed with tap water. Skin findings were scored 30-60 min, 24 h, 48 h, 72 h and 7 and 14 days after removal. No skin findings were noted in the animals exposed for 3 minutes. Signs of moderate to severe irritation were observed in the animal exposed for 4 hours. These findings were not reversible within the 14 days-observation period. Therefore the test item was concluded to be corrosive to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1984-09-04 till 1984-09-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: VPS 11-ROM T3, technical grade material
- Purity test date: 1984-04-03
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 22 °C - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 2200-3700 g
- Housing: single
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, Altromin-GmbH (Lage/Lippe, Germany) ad libitum
- Water: deionized, chlorinated water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: ca. 71 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations were caried out 30-60 min and 24, 48, 72 h and 7 days after removal of the test substance.
- Number of animals:
- 3 animals (4 hours exposure)
- Details on study design:
- TEST SITE
- Area of exposure: dorsal to lateral, about 2.5 x 2.5 cm
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
30-60min, 24 h, 48 h, 72 h, 7 days
SCORING SYSTEM:
Erythema and edema were scored according to a 5 graded scale. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- The animal exposed for 4 hours exhibited mild to moderate erythema at the observation time points 30-60 min, 24, 48, 72 h (score 1 or 2). After 7 days all erythema disappeared. Therefore, the findings were considered reversible.
Edema were scored 1 or 0 at the time points 24 h. On all other timepoints no edema were detected. Therefore, the findings were considered reversible. - Other effects:
- - Other adverse local effects: The skin appeared dry after 72 hours exposure and dry and scaled after 7 days. After 14 days the skin appeared normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not considered to be classified as skin corrosive or irritant based on the test results..
- Executive summary:
The test material (technical grade) was applied to the clipped skin of three New Zealand White rabbits. 0.5 mL were applied under semiocclusive dressing. The animals were exposed for 4 hours. After removal of the patches the test sites were washed. Skin findings were scored 30-60 min, 24 h, 48 h, 72 h and 7 and 14 days after removal. Signs of mild to moderate irritation were observed in the animal exposed for 4 hours, but hese findings were fully reversible within the 14 days-observation period. Therefore the test item (technical grade) was concluded to be not corrosive and not irritating to skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The test material (at technical grade) was applied to the clipped skin of three New Zealand White rabbits. 0.5 mL were applied under semiocclusive dressing. The animals were exposed for 4 hours. After removal of the patches the test sites were washed. Skin findings were scored 30-60 min, 24 h, 48 h, 72 h and 7 and 14 days after removal. Signs of mild to moderate irritation were observed in the animal exposed for 4 hours, but hese findings were fully reversible within the 14 days-observation period. Therefore the test item (technical grade) was concluded to be not corrosive and not irritating to skin.
The test material was further examined for its potential to cause skin irritation/corrosion in another study with New Zealand White rabbits. 500 mg were diluted with 0.05 mL 0.9 % NaCl and applied under semiocclusive dressing. Three animals were exposed for 3 minutes, one animal was exposed for 4 hours. After removal of the patches the test sites were washed with tap water. Skin findings were scored 30-60 min, 24 h, 48 h, 72 h and 7 and 14 days after removal. No skin findings were noted in the animals exposed for 3 minutes. Signs of moderate to severe irritation were observed in the animal exposed for 4 hours. These findings were not reversible within the 14 days-observation period. Therefore the test item was concluded to be corrosive to skin.
Despite of the first study (only technical grade was used), the substance to be registered is considered to be classified as corrosive to skin.
Eye irritation/corrosion:
The local effect of the test item (at technical grade) was investigated according to the method recommended in the OECD Guideline No. 405. Three albino rabbits were exposed to 0.1 mL of the test article, applicated undiluted in one eye. The eyes were examined and the changes were graded according to a numnerical scale one hour, 24, 48 and 72 hours after dosing. Additional examinations were conducted after 7 and 14 days. The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405. Three albino rabbits were exposed to 0.1 mL of the test article, applicated undiluted in one eye. The eyes were examined and the changes were graded according to a numnerical scale one hour, 24, 48 and 72 hours after dosing. Additional examinations after 7 and 14 days. From 1 hour after application onwards chemosis was observed, which increased over time in all test animals. It was not possible to assess the conjunctivae score due to a whitish discolouration of the conjunctivae and nicitating membranes. Cornea opacity was observed in all treated eyes from 1 hour p.a. onwards, reversibility could not be assessed as in one animal the application led to destruction of the complete eyeball on day 7, in the remaining two animals on day 14. In conclusion the test item causes serious eye damage (Category 1).
Although the study was conducted with the test material of lower purity (technical grade) no further testing is required as besides this in vivo eye irritation study the results from the skin irritation study with the pure test material already triggers classification as corrosive to skin and causing irreversible damage to the eyes.
Justification for classification or non-classification
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 to be classified as corrosive to skin (cat 1C) and labelled with H314: 'Causes severe skin burns and eye damage' under Regulation (EC) No 1272/2008, and as corrsosive to the eyes (cat 1) and lebaled with H318: 'Causes serious eye damage' as amended for the tenth time in Regulation (EU) No 2017/776.
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