Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 474-870-9 | CAS number: -
- 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
The test substance does not have skin- or eye-irritating properties.
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:
- 13 January 1998 to 20 January 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.1 - 3.8 kg
- Housing: Full air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 hours daily - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4ml - Duration of treatment / exposure:
- Exposure 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: surgical plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.
Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar formation all animals : 1.7
animal 66 : 1.3
animal 67 : 2.0
animal 68 : 1.7
Oedema formation all animals : 0.3
animal 66 : 0.3
animal 67 : 0.3
animal 68 : 0.3
Based on the results of this study the substance is slightly irritating to skin. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- 30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.
Based on the results of this study the substance is slightly irritating to skin. The substance does not meet the EU criteria for classification on the basis of the effects noted. - Executive summary:
This study is read across to a close structural analogue, which is considered to be structurally equivalent to the substance to be registered, in that only the halogen ion differs. The study was conducted according to EU test guidance 92/69/EEC part B4 and OECD guideline 404 in compliance with GLP.
30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.
Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated:
Erythema and eschar formation
animal #1 : 1.3
animal #2 : 2.0
animal #3 : 1.7
Oedema formation
animal #1 : 0.3
animal #2 : 0.3
animal #3 : 0.3
Based on the results of this study the substance is slightly irritating to skin. The substance does not meet the CLP criteria for classification on the basis of the effects noted.
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 April 2007 to 27 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: Rabbit
Strain: New Zealand White rabbits
Source: TETRABBIT Kft., HUNGARY
Justification of strain: The New Zealand White rabbit is one of the standard species of acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined 24 hours prior to the start of study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Number of animals: 3 animals
Age of animals at arrivals: 10 weeks old, adult albino rabbit
Sex: male
Body weight range:
at the beginning of the study: 3378-3482 g
at the end of the study: 3555-3595 g
Date of receipt: 27 March 2007
Acclimatisation time: 24 days
Animal identification: The individual identification was performed by numbered ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.
Number of animal room: 618
Housing: Animals were housed individually in metal cages.
Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Food and Feeding: Animals received PURINA Base – Lap gr. diet for rabbit produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
Water Supply: Animals will receive as tap water from automatic self- service water system ad libitum.
Quality Control of Water: The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out after the application of test item.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72 hours then one week after the treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The eyes of the test animals were not washed out after the application of test item.
The eye irritation scores were evaluated according to the scoring system by Draize. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The eyes were examined at 1, 24, 48, 72 hours then 1 week after the application.
One hour after treatment the vessels were diffuse and the individual vessels were not easily discernible (score 2), were found in all animals. In animal No.: 7171 the discharge with moistening of the lids and hairs, on considerable area around the eye (score 3) in other animal (No.: 7185) the discharge with moistening of the lids and hairs just adjacent to lids (score 2) occurred and in animal No.: 7159 the amount of discharge was greater than normal (score 1).
Chemosis was not observable during the study.
There were no effects observed in the cornea and iris during the study period.
24 hours after treatment some hyperaemic blood vessels (score 1) were observed in animal No.: 7159. In two cases (No.: 7185, 7171) the vessels were more diffuse (score 2).
Discharge alterations were not found at this time.
48 hours after treatment some blood vessels hyperaemic (score 1) were found in all animals.
72 hours after treatment in two animals (7185, 7171) the scores of the redness did not change compared to the previous observation. The animal No.: 7159 became fully symptom-free by this time.
1 week after treatment the study was terminated, since no primary irritation symptoms occurred.
During the study the control eyes of animals were symptom-free.
General state and the behaviour of animals were normal throughout the study period.
There were no notable body weight changes during the contact and observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, test item Gelb Sulfato applied to the rabbits' eye mucosa, caused temporary slight conjunctival reddening, which was fully reversible within one week. No other adverse effects were noted.
Consequently, the test substance is not an eye irritant. - Executive summary:
The acute eye irritation study of the test item Gelb Sulfato was performed in New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method.
The study was performed in accordance with the study plan, the OECD Guideline for Testing of Chemicals No. 405, Directive 2004/73/EEC B.5 and the Principles of Good Laboratory Practice (GLP) and is reported with a GLP certificate. The test item was placed into the conjunctival sac of left eye of each animal. The untreated right eye served as control. 0.1 g of the test item was used for the study in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48, 72 hours then one week after the application.
One hour after the single application of test item Gelb Sulfato into the eye of the rabbits moderate redness and slightly to severely increased discharge were observed in the eye of the test animals. There were no effects observed in the cornea, iris and conjunctival chemosis during the study period. 72 hour after the application in two cases slight redness were found, one animal became fully symptom-free by this time. 1 week after treatment the study was terminated, since no primary irritation symptoms occurred.
During the study the control eyes of animals were symptom-free. General state and the behaviour of animals were normal throughout the study period.
There were no notable body weight changes during the contact and observation period.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00
redness : 1.33, 0.66, 1.33
chemosis : 0.00, 0.00, 0.00
discharge : 0.00, 0.00, 0.00
In conclusion, test item Gelb Sulfato applied to the rabbits' eye mucosa, caused slight to moderate conjunctival irritant effects, which were fully reversible within one week.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
Reference
MEAN VALUES OF EYE IRRITATION SCORES FOR EU CLASSIFICATION
(24, 48, 72 hour reading)
Animal Number |
Sex |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
7185 |
Male |
0.00 |
0.00 |
1.33 |
0.00 |
0.00 |
7159 |
Male |
0.00 |
0.00 |
0.66 |
0.00 |
0.00 |
7171 |
Male |
0.00 |
0.00 |
1.33 |
0.00 |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / Corrosion.
Two studies for skin irritation were used in a weight of evidence approach from 2 different very close structural analogues. both studies were conducted according to EU test guidance 92/69/EEC part B4 and OECD guideline 404 in compliance with GLP.
In the first study, 60 minutes after removal of the plaster the animals showed very slight erythema, which was no longer visible after 24 hours.
In the second study, 30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversed.
Based on the results of these studies, it is concluded that the test substance is not irritating to skin. The substance does not meet the CLP criteria for classification on the basis of the effects noted.
Eye irritation.
The acute eye irritation study of the test item Gelb Sulfato was performed in New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method. The study was performed in accordance with the study plan, the OECD Guideline for Testing of Chemicals No. 405, Directive 2004/73/EEC B.5 and the Principles of Good Laboratory Practice (GLP) and is reported with a GLP certificate. The test item was placed into the conjunctival sac of left eye of each animal. The untreated right eye served as control. 0.1 g of the test item was used for the study in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48, 72 hours then one week after the application.
One hour after the single application of test item Gelb Sulfato into the eye of the rabbits redness and increased discharge were observed in the eye of the test animals within the first 3 days after test substance administration. There were no effects observed in the cornea, iris and conjunctival chemosis during the study period. 72 hour after the application in two cases slight redness were found, one animal became fully symptom-free by this time. 1 week after treatment the study was terminated, since no primary irritation symptoms occurred.
During the study the control eyes of animals were symptom-free. General state and the behaviour of animals were normal throughout the study period.
There were no notable body weight changes during the contact and observation period.
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for irritation effects is therefore required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.