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EC number: 201-873-2 | CAS number: 88-99-3
- 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
No irritating or corrosive property to skin of the test item was determined by the two 3D skin models used (Wingenroth, 2010).
The irritant / corrosive potential of the test substance was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002 and the EEC Directive No. 440/2008 Part B - Method BA. According to classification criteria the test substance is not an irritant to the skin (Gmelin, 2010).
The test substance was identified as "non irritant" to the Chorioallantoic membrane (Irritation Score (IS) = O)in a HET-CAM assay (Wingenroth, 2010).
The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days (Gmelin, 2011).
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Preparation of test site:
- other: On the day before the test, the fur was shorn on the right and left side from the dorso-lateral area of the trunk of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used.
- Controls:
- other: The surrounding untreated skin served as control.
- Duration of treatment / exposure:
- Due to a possible irritant potential of the test substance, in the first step only one animal was used and three test patches were applied successively to this animal, as described above. The first patch was removed after three minutes. As no serious skin reactions were observed, the second patch was applied and removed after one hour. At this stage the observations indicated that with respect to animal welfare the exposure can be allowed to extend to four hours, therefore the third patch was applied and removed after four hours and the responses were graded one hour later.
The test was completed using two additional animals, exposed for four hours. - Observation period:
- Based on most recent guidelines the dermal irritation was scored approximately at 1, 24, 48 and 72 hours after patch removal. If no irritation indices were observed, after 72 h, the study was finished. If dermal irritation was observed, animals were monitored usually on day 7 and 14 after patch removal until the changes had completely subsided, however for not more than 14 days after application.
- Number of animals:
- Three animals were used for the study.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The irritant / corrosive potential of the test substance was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002 and the EEC Directive No. 440/2008 Part B - Method BA. According to classification criteria the test substance is not an irritant to the skin. There were no systemic intolerance reactions.
Reference
Summary of Irritant Effects (Score)
Animal | Effect | 24 h | 48 h | 72h | Mean scores | Response | Reversible (days) |
1 | Erythema (redness) and eschar formation | 0 | 0 | 0 | 0.0 | - | 1* |
Oedema formation | 0 | 0 | 0 | 0.0 | - | na | |
2 | Erythema (redness) and eschar formation | 0 | 0 | 0 | 0.0 | - | na |
Oedema formation | 0 | 0 | 0 | 0.0 | - | na | |
3 | Erythema (redness) and eschar formation | 0 | 0 | 0 | 0.0 | - | 1 |
Oedema formation | 0 | 0 | 0 | 0.0 | - | na |
no positive response : mean scores <2 = -
positive response : mean scores , >2 = +
na: not applicable
* : in respect of the result 1 h post application
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- For reasons of animal welfare a sequential testing strategy was followed in accordance with the current version of the EEC Directive No. 440/2008 and the OECD Guideline No. 405, irrespective of the requirements of other guidelines for testing for eye irritation/corrosion in rabbits.
This testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the eye or the skin, the performance of a SAR evaluation for eye and skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity via the dermal route, the performance of a validated in vitro test for skin corrosion (T 3081239, not corrosive), an in vitro test for skin irritation (T 2081238, not irritating) and an in vitro HET-CAM test for mucosal irritation hazard before in vivo testing for eye irritation/corrosion in rabbits.
The in vitro HET-CAM test is archived under T 5081240. The test compound is not irritating. - GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye, which remained untreated, served as control.
- Duration of treatment / exposure:
- 0.1 g of the pulverized test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The treated eye was rinsed 1 hour following instillation.
Because of the fact that one hour after treatment a severe irritation was observed in the first animal, only one further rabbit was treated as described. - Observation period (in vivo):
- Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application (in the following p.a.). If no irritation indices were observed after 72 h, the study was finished. If eye irritations were observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however for not more than 21 days after application.
- Number of animals or in vitro replicates:
- Two animals were used for the study.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days. There were no systemic intolerance reactions.
Reference
Summary of Irritant Effects (Score)
Animal | Effect | 24 h | 48 h | 72 h | Mean scores | Response | reversible (days) |
1 | corneal opacity | 4 | 3 | 3 | 3.3 | ++ | 14 |
iritis | * | 1 | 0 | 0.5 | - | 3 | |
redness conjunctivae | 2 | 3 | 3 | 2.7 | + | 7 | |
chemosis conjunctivae | 2 | 2 | 2 | 2.0 | + | 7 | |
2 | corneal opacity | 2 | 2 | 2 | 2.0 | + | 7 |
iritis | 1 | 1 | 1 | 1.0 | + | 7 | |
redness conjunctivae | 2 | 2 | 2 | 2.0 | - | 7 | |
chemosis conjunctivae | 3 | 2 | 1 | 2.0 | + | 7 |
response:
corneal opacity: mean scores < 2 = -, = 2 < 3 = +, = 3 = ++
iritis: mean scores < 1 = -, = 1 < 2 = +, = 2 = ++
conjunctival redness: mean scores < 2.5 = -, = 2.5 = +
conjunctival oedema : mean scores < 2 = -, = 2 = +
* Iris not observable, therefore not to investigate.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
A study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin was performed. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, ST. Katharinen, Germany) for detection of topically applied skin corrosives with the test item. Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. A 100% concentration was tested on the skin/ epidermal equivalents in triplicate. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min. respectively. Thus the study was conducted in accordance with the 431 guideline as well as with an EC guideline (amending Council Directive 67/548/EEC, B.40 Skin Corrosion) using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion". To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular interval in the lab. The reliability check is always performed by two technicians, in two laboratories in parallel using the same batches of the control test items.
The test item was applied at a 100% concentration, i.e. 25 mg per insert (plus 50µl 0.9% NaCl to moisten and ensure good contact with the skin).
The test result shows that no corrosive property of the test item was determined by the assay used (Wingenroth, 2010).
Another study which allows the hazard identification of irritant substances in accordance with UN GHS category 2, was performed. The experiment was carried out according to EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany). Undiluted test substance was applied topically to the RHS model, i.e. 30 mg per insert (plus 30 µg 0.9% NaCI to moisten and ensure good contact with the skin; three replicates). After an exposure period of 20 minutes, followed by a 42 hours post treatment incubation period, the cell viability was measured to be 99.56% in the MIT (Methylthiazoletetrazolium) conversion assay. The results of the concurrent negative control (NC, 0.9% NaCI) and positive control (PC, 5% SOS) demonstrated the viability (NC) and sensitivity (PC) of the test model. Thus, the results show that the test substance is considered to have no skin irritation category (Wingenroth, 2010).
The irritant / corrosive potential of the test substance was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002 and the EEC Directive No. 440/2008 Part B - Method BA. According to classification criteria the test substance is not an irritant to the skin. There were no systemic intolerance reactions (Gmelin, 2010).
Hen's egg tests are used to determine the potential irritant/ corrosive property of a test compound using an in vitra alternative to the Draize methodology (OECD405). The test substance was tested by observing possible adverse changes after application onto the Chorioallantoic membrane (HET-CAM). After the application of the test item blood vessels and albumin were examined and scored for the following irritant effects: vasodilatation, slight hemorrhage; vessel lysis, strong hemorrhage; blood coagulation, albumen coagulation for a period of 300 seconds. 300 µl of the test item was applied per egg directly on the Chorioallantoic membrane. The test substance was identified as "non irritant" to the Chorioallantoic membrane (Irritation Score (IS) = O) under the conditions of this assay.
The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days. There were no systemic intolerance reactions (Gmelin, 2010 DRAFT).
Justification for classification or non-classification
According to the available test results and respective classification criteria the test substance is not an irritant to the skin and needs no classification as an skin irritant or as skin corrosive.
The Compound is labeled with R41 (risk of serious damage to eyes); according to REACH TGD ´Guidance on information requirements and chemical safety assessment, Part E: Risk Characterization, May 2008´ this translates to the “moderate hazard band”.
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