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EC number: 700-903-6 | CAS number: 255830-15-0
- 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
The key skin irritation study, conducted in a similar manner to OECD Test Guideline 404 and in compliance with GLP, reported the test as not irritating to skin after a 4-hour semi-occlusive exposure in rabbit, with erythema and oedema scores of zero (Huntingdon Life Sciences 1996a).
The key eye irritation study, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, found the test material as mildly irritating to rabbit eyes (Huntingdon Life Sciences 1996b). The test material produced reversible conjunctival redness in two of three animals. However, the effects observed were not sufficient for classification.
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:
- 3 - 6 September 1996
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Regal group UK Ltd., Great Bookham, Surrey, England
- Age at study initiation: 13 weeks
- Weight at study initiation: 3-3.1 kg
- Housing: individually in metal cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes, however duration unclear
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): ca. 19/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): as supplied - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin was made on Day 1 (ca. 60 minutes after removal of the dressing) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
- Number of animals:
- 2 females and 1 male
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar
- Type of wrap if used: Each treatment site was covered with Elastoplast elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with warm water. The treated area was then blotted dry with absorbent paper.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Local irritation was assessed using a prescribed numerical system which ran from 0-4 for erythema and for edema, 4 being the most severe reaction. - Irritation parameter:
- erythema score
- 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
- 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
- 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
- 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
- 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
- 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 dermal response to treatment was observed for any animal throughout the study.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A skin irritation study, conducted in a similar manner to OECD 404 and in compliance with GLP, concluded that ATMP-N-oxide was not irritating to the skin of rabbit.
Reference
A single semi-occlusive application of SPE9402 to intact rabbit skin for four hours elicited no dermal irritation.
Active acid 19.1%
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:
- 11 - 20 September 1996
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Regal Group UK Ltd., Great Bookham, Surrey England
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 3-3.6 kg
- Housing: individually in metal cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3 days after instillation (24, 48 and 72 hours). Additional observation was made for main study animals four days after treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: numerical scoring system similar to Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- There were no signs of toxicity or ill health in any rabbit during the observation period. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels to a diffuse crimson colouration of the conjunctivae with slight swelling was observed, resolving in all instances four days after instillation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study, conducted in a similar manner to OECD TG 405 and in compliance with GLP, ATMP-N-oxide was found mildly irritating to the eyes of rabbit.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
60 min |
0/0/0 |
0/0/0 |
2/1/1 |
1/1/1 |
24 h |
0/0/0 |
0/0/0 |
2/2/1 |
1/2/1 |
48 h |
0/0/0 |
0/0/0 |
1/2/1 |
1/1/0 |
72 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
1.3 |
0.7 |
Instillation of the test material into the rabbit eye elicited transient, very slight to well defined conjunctival irritation only.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The most reliable available studies were chosen as key, which provided sufficient information to allow for classification decision. In both key studies for skin and eye irritation, the form of substance to which animals were exposed is ATMP-N-oxide potassium salt at pH 11.3. High pH (11.3) of the test material in the key study suggests that the ATMP-N-oxide potassium salt would be severely irritating or corrosive to skin and eyes. According to the tiered approach in Regulation (EC) 1272/2008 for classification for skin irritation under EU GHS, existing human/animal data are to be considered first if available, and classification should be based on these data. A default classification derived from pH alone is only required if no reliable test data are available.
The key skin irritation study, conducted in a similar manner to OECD Test Guideline 404 and in compliance with GLP, exposed 2 female and 1 male New Zealand White rabbits to a single amount of 0.5 mL of ATMP-N-oxide-5K to the dorso-lumbar region. The treatment sites were semio-cclusive and covered with Elastoplast elastic adhesive dressing for 4 hours. After 4 hours, the treated area was washed with warm water and blotted dry with absorbent paper. The local irritation was then examined after 60 minutes and at day 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure) after the removal of the dressing. No mortality or signs of toxicity occurred throughout the study. Additionally, no erythema or oedema at any time were observed. Therefore, it was concluded that ATMP-N-oxide-5K was not irritating to skin (Huntingdon Life Science, 1996b).
In the supporting skin irritation study, conducted in a similar manner to OECD Test Guideline 404 and in compliance with GLP, 3 male New Zealand White rabbits were exposed for 4 hours under occlusive coverage. Observations occurred at 1, 24, 48 and 72 hours after patch removal. No skin irritation at any time point, no mortality, clinical signs or behavioural alterations were observed (RBM, 1991c).
In the key eye irritation study, conducted in a similar manner to OECD Test Guideline 405 and in compliance with GLP, 1 New Zealand White rabbit was treated in advance of the other 3 rabbits to ensure that if a severe response was produced, no further animals would be exposed. The treated eye of this animal was rinsed with distilled water 30 seconds after instillation for a duration of 30 seconds. No corneal damage or iridial inflammation was observed. A diffuse crimson colouration of the conjunctivae was seen, resolving two days after treatment. 3 New Zealand White rabbits were in total treated by a single instillation of 0.1 mL of ATMP-N-oxide to the eyes. Examination of the eyes were done after 1, 24, 48 and 72 hours for cornea opacity, iris, chemosis and conjunctivae irritation. No corneal damage or iridial inflammation were observed. Hyperaemia of blood vessels to a diffuse crimson colouration of the conjunctivae with slight swelling was observed, however, this was resolving in all instances by four days after instillation. No signs of mortality or toxicity was observed in any of the animals during the observation period (Huntingdon Life Sciences, 1996b).
In a supporting eye irritation study, conducted in a similar manner to OECD Test Guideline 405 and in compliance with GLP, 3 male New Zealand White rabbits were treated with a single administration of ATMP-N-oxide. All observed endpoints evidenced that no indication of irritation occurred at any time (RBM, 1991d).
Skin and eye irritation data for ATMP-H have been included to support read-across within the ATMP and ATMP-N-Oxide Category.
In an in vivo skin irritation study with ATMP-H, conducted according to OECD Test Guideline 404 and in compliance with GLP, ATMP-H was not irritating to the skin of rabbits (SafePharm Laboratories, 1982).
In a summary of an eye irritation study with ATMP-H, conducted prior to the adoption of OECD Test Guidelines and GLP, finely ground powder of ATMP-H caused moderately severe eye irritation to rabbit eyes (Younger Laboratories, 1967c).
Justification for classification or non-classification
Reliable studies for skin and eye irritation of the 5K salt of ATMP-N-oxide at pH range 9.5-11.5 demonstrate no irritation. Therefore, ATMP-N-oxide 5K does not require classification for skin or eye irritation according to Regulation (EC) No 1272/2008.
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