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EC number: 620-582-5 | CAS number: 301341-58-2
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
In an in vivo study with a structural analogue or surrogate of the test item performed with New Zealand White rabbits according to OECD test guideline no. 404, the application to the skin resulted in mild to moderate signs of irritation. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Based on the results, the substance was not regarded a skin irritant according to EU classification criteria.
In an in vivo study with a structural analogue or surrogate of the test item performed with New Zealand White rabbits according to OECD test guideline no. 405, no abnormal findings were observed in the treated eye of any animal 7 days after treatment. No corrosion of the cornea was observed at any of the reading times.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo study
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-11-T.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- 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: Harlan Netherlands BV
- Age at study initiation: 14 weeks (males, females)
- Weight at study initiation: 2.2 kg (male); 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark / light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / animal
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hour
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- % coverage: 100
- Type of wrap if used: surgical gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Irritation scoring according to Council Regulation (EC) No 440/2008 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h/
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.11
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Other effects:
- Scaling noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Hostapon SG as applied is not irritating to skin
- Executive summary:
The primary skin irritation potential of an aqueous solution of the registered UVCB substance (active content 25%) was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 1.33, 1.67 and 2.00, respectively and the mean oedema score was 1.00, 1.33 and 1.00, respectively. The application of Hostapon SG to the skin resulted in mild to moderate signs of irritation. These included erythema, oedema, scaling and dry / inelastic skin. In the male, these effects were reversible and were no longer evident 14 days after treatment. Both females were still observed with scaling of the skin on day 14 post treatment, the end of the observation period. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Based on the results, the registered substance is not regarded a skin irritant according to EU classification criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-11-T.
- 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:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 15 weeks (male), 16 weeks (females)
- Weight at study initiation: 2.4 kg (male), 2.5 - 2.6 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark / light cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: numerical scoring system according Council Regulation (EC) 440/2008
TOOL USED TO ASSESS SCORE: fluorescein, diagnostic-lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 h / 48 h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no signs of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.77
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.77
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the EU classification criteria Hostapon SG as applied is considered as very mildly irritating to the rabbit eye. All effects were reversible.
- Executive summary:
The test item was tested for primary eye irritation according to OECD 405 and GLP. 0.1 mL of the test item was applied into the left conjunctival sac of 3 rabbits. The right eye served as a control. Assessments were made 1, 24, 48 and 72 hours p.a. as well as 7 days after treatment. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.67, 2.00 and 1.67 for reddening and 2.00, 1.33 and 2.00 for chemosis, respectively. Slight to moderate reddening of the conjunctivae was noted in all animals 1 to 72 hours after treatment. Slight to marked swelling of the conjunctivae (chemosis with half-closed lids) was observed in all animals 1 to 72 hours after treatment. Moderate reddening of the sclera was present in one animal 1 to 72 hours after treatment. Due to the marked swelling (with halfclosed lids) of the conjunctivae, the assessment of the sclera was first prevented in two animals. When assessable at the 24-hour reading, a moderate reddening of the sclera was noted. Slight to moderate ocular discharge was recorded in all animals 1 to 72 hours after treatment. No abnormal findings were observed in the treated eye of any animal 7 days after treatment. No corrosion of the cornea was observed at any of the reading times.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test item caused only slight skin and eye irritation in studies with experimental animals. As all effects were reversible, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.
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.
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