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EC number: - | CAS number: 42355-78-2
- 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
Not skin irritating.
Not eye irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test procedures cannot be subsumed under testing guideline, nevertheless are well documented and scientifically acceptable. Justification for Read Across is reported in the endpoint summary and in the Category Justification Report attached to Section 13 of this dossier.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
- Age at study initiation: approx. 12 -14 weeks.
- Weight at study initiation: 2220 g - 2770 g.
- Housing: individually.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12/12 hrs dark / hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 12 - 16 square cm
- Type of wrap if used: aluminium foil.
SCORING SYSTEM: OECD Scoring System. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Slighly erythema was robserved in one rabbit. The effect is reverseble within 72 hours.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Non irritating.
- Executive summary:
Method
The skin irritation potential was tested in New Zealand White rabbits. The procedure used are similar to those described in the OECD Guidelines 404.
Results
Slight erythema was observed in one rabbit. The effect is reversible within 72 hours.
Conclusion
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).
In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1272/2008) Regulation.
Reference
Animal/sex | Reaction | 1 hr | 24 hrs | 48 hrs | 72 hrs | Mean 24, 48 and 72 hrs |
1 | Erythema | 0 | 0 | 0 | 0 | 0.00 |
2 | Erythema | 2 | 1 | 0 | 0 | 0.33 |
3 | Erythema | 1 | 0 | 0 | 0 | 0.00 |
1 | Oedema | 0 | 0 | 0 | 0 | 0.00 |
2 | Oedema | 0 | 0 | 0 | 0 | 0.00 |
3 | Oedema | 0 | 0 | 0 | 0 | 0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- From April 14 to 18, 1988.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test procedures cannot be subsumed under testing guideline, nevertheless are well documented and scientifically acceptable. Justification for Read Across is reported in the endpoint summary and in the Category Justification Report attached to Section 13 of this dossier.
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Eye and the Chicken Chorioallantoic Membrane (BECAM ASSAY).
- GLP compliance:
- yes
- Details on test animals or tissues and environmental conditions:
- Calf eyes were obtained from a local slaughterhouse (Viguurs, 's-Hertogenbosch). The eyes were excised by standard procedures within 15 minutes after killing the animal. They were transported to the laboratory and examined for injuries. This was done by holding the eyes submersed in saline; eyes with corneal damage or other abnormalities were discarded. The selected eyes were preserved at ambient temperature (approximately 20 °C) under saline not longer than 4 hours.
White eggs were obtained from a chicken breeding centre.
Date of arrival: April 5, 1988.
They were transported at a temperature between 15 and 20 °C.
After approximately 6 hours of rest, the incubation was started by placing the eggs in the incubator with the air chamber upwards.
The temperature was maintained at 37-38 °C and the relative humidity between 50 and 70 %. The eggs were turned once every hour.
They were candled at the seventh day of incubation; unfertilized eggs or eggs containing a dead embryo were removed. - Amount / concentration applied:
- Calf eyes: 0.1 ml
eggs: 0.2 ml - Duration of treatment / exposure:
- calf eyes: 30 sec
eggs: 20 sec - Observation period (in vivo):
- calf eyes: 10 min
eggs: 30 sec, 1.5 and 4.5 min - Number of animals or in vitro replicates:
- 5 calf eyes
- Irritation parameter:
- other: all paramteres
- Remarks on result:
- other: See details on method and results
- Interpretation of results:
- other: BE assay: not irritating (according to the CLP Regulation). CAM assay: inconclusive (according to the CLP Regulation).
- Conclusions:
- Today a validated methods and procedures protocol about the Bovine Eye assay is available. The differences between the present test and the validated protocol are not suspected of impairing the results. Therefore, it can be concluded that the substance is not irritating, based on the BE assay.
In the case of the CAM assay the protocol is not validated yet and the re-evaluation of the result obtained is not appicable. Therefore, the CAM assay can be considered as inconclusive. - Executive summary:
Method
The eye irritation potential was assessed according to the in vitro Bovine Eye and the Chicken Chorioallantoic Membrane (BECAM ASSAY) method.
Results
The test substance induced no effects in the bovine eye.
The effects on the CAM consisted of vascular injection almost instantly after application. In three eggs (no. 1, 3 and 4) haemorrhages were scored 2 minutes after application. On account of these results it is expected that eye contact with the test substance may lead to slight irritation. Acute corneal effects may be negligible.
Conclusion
Today a validated methods and procedures protocol about the Bovine Eye assay is available. The differences between the present test and the validated protocol are not suspected of impairing the results. Therefore, it can be concluded that the substance is not irritating, based on the BE assay.
In the case of the CAM assay the protocol is not validated yet and the re-evaluation of the result obtained is not appicable. Therefore, the CAM assay can be considered as inconclusive.
Reference
BE ASSAY
Treatment | Opacity | Detachment | Fluorescence | Total |
Neg. control | 0 | 0 | 0 | 0 |
Toluene | 0 | 0 | 1 | 1 |
Acetone | 2 | 0 | 1.5 | 3.5 |
Eye1 | 0 | 0 | 0 | 0 |
Eye2 | 0 | 0 | 0 | 0 |
Eye3 | 0 | 0 | 0 | 0 |
Eye4 | 0 | 0 | 0 | 0 |
Eye5 | 0 | 0 | 0 | 0 |
Mean |
0 |
CAM assay
30 sec | 2 min | 5 min | Total | ||||||||
Time | Egg | I | H | C | I | H | C | I | H | C | |
09:37 | 1 | + | - | - | + | - | - | + | + (a) | - | 3 |
09:40 | 2 | + | - | - | + | - | - | + | - | - | 2 |
09:43 | 3 | + | - | - | + | - | - | + | + (a) | - | 3 |
09:46 | 4 | + | - | - | + | - | - | + | + (a) | - | 3 |
Mean: | 2.75 |
a: Bleeding by 2 min
The total scores are not consistent with the above mentioned scoring system (table 2). According to this scoring in table 2 the total score for egg 1 -4 would be: 4.5, 3.5, 4.5, 4.5, respectively, which would lead to a mean score of 4.25. The score of 4.25 would lead to moderate irritation.
REFERENCE SUBSTANCES
For toluene, a score of 1.0 was obtained in the BE assay whereas the average score in the CAM assay was 1.25.
Acetone treatment resulted scores of 3.5 in the BE assay and an average score of 2.5 in the CAM assay.
As the effects, produced by acetone and toluene, fell within the historical range and the untreated eyes and eggs showed no signs of irritation, the results were considered to be valid.
To evaluate the effects observed in both assays the documented in vivo effects of the two reference substances toluene and acetone were taken into consideration. Toluene produces slight transient conjunctival irritation with negligible to slight corneal epithelial damage without opacity in the rabbit eye, while no serious effects have been reported in case of accidental exposure of human eyes.
Acetone causes temporary edema and moderate corneal opacity with epithelial damage to exposed rabbit eyes while in man reversible corneal opacity has been observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No specific tests on the substance under registration was been performed; nevertheless the substance belongs to the Stilbene Fluorescent Whitening Agent category, group 1, in which the members share the common organic functional group diethylamino derivative, with different sulphonation degrees: tetrasulphonated (OB 1 -MSA) and hexasulphonated (OB 1 -DSA). The hexasulphonated is the best conservative representative in the group because of the structural similarity and the lower water solubility.
Read across within the same group is well justified in this case, also taking into account the impurities of the considered substances, since the identified organic impurities can have different substitution on the molecule, but the functional reactive groups are potentially the same, and molecules are of the same molecular size and polarity of the main component. As a consequence the systemic absorption and reactivity is practically the same than the main constituent and Read Across is justified.
The studies performed on OB 3a-MSA, the analogue dihydroxyethylamino derivative tetrasulphonated,, are reported here as supporting reference. The diethylamino substituent is less polar, less reactive and makes the molecule slightly less soluble compared to the dihydroxyethylamino derivative. Thus, the latter can be considered as a representative conservative analogous for the irritation endpoints.
Within the whole category, eleven over fourteen registered substances were tested and none of the existing tests arisen any concern for skin and eye irritation.
All substances of the category were modelled using the OECD Toolbox and the provisional results about skin and eye irritation were calculated for all members: no alerts were reported (see category Justification Report attached to the section 13) for inclusion for any substance.
Based on all those considerations, the available studies on the analogous substances are representative for the substance under registration; thus it can be considered not irritant for skin and eye.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible damage to the skin following the application of a test substance for up to 4 hours are classified in Category 2 (irritating to the skin) if:
(1) 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 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
In the skin irritation test, mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).
According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
Today a validated methods and procedures protocol about the Bovine Eye assay is available. The differences between the present test and the validated protocol are not suspected of impairing the results. Therefore, it can be concluded that the substance is not irritating, based on the BE assay. This result is confirmed by the supporting study in which the mean values from gradings at 24, 48 and 72 hours for both rinsed and unrinsed eyes were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.
The available experimental data are adequate for classification and labelling and the results show that the substance is not classified for eye and skin irritation, according to the CLP Regulation (EC 1272/2008).
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