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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 279-091-6 | CAS number: 79135-90-3
- 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
In a OECD guideline compliant primary skin irritation test in rabbits neither erythema nor edema were observed 1, 24, 48 and 72 hours after application of the test substance. Therefore, the test item has to be regarded as not irritating to skin.
The primary eye irritation potential of the test item was investigated according to a OECD test guideline No. 405.
The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iritis, redness and chemosis of the conjunctivae. The individual mean scores for corneal opacity and iritis was 0.0 for all animals. Mean scores for the conjunctivae were 0.33 for reddening and 0.22 for chemosis.
All observed effects were reversible within 48 hours. No corrosion was observed at any of the measuring intervals. No clinical signs of toxicity were observed.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well performed guideline study according to OECD 404
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 kg to 3.0 kg
- Housing: Individually in stainless steel cages equipped with an automatic drinking water supply and cleaning system
- Diet (e.g. ad libitum): standard rabbit maintenance feed Kliba 23/341/1, Klingentalmuehle AG ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 2°C (air-condition)
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethyleneglycol 400/saline (70:30)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 %
VEHICLE
- Amount(s) applied (volume or weight with unit):1.0 ml to moisten the test item
- Lot/batch no. (if required): Ch-B 2322 , Riedel de Haen AG
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 (2 females, 1 male)
- Details on study design:
- Before Treatment the entire back and the flank of the rabbits were closely clipped with electric clippers. Application was made to the intact skin site on the clipped dorsum of each rabbit.
TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch, covered with aluminium foil; trunk of the animals was wrapped with an occlusive bandage of elastic adhesive dressing.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
the condition of the intact skin site was observed at 1, 24, 48, and 72 h following removal of bandage and gauze patch, unless the skin is normal at 7 or 14 days; assesment according to Draize J.H. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritant / corrosive response data:
- no destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect had occured on the skin.
- Other effects:
- In the area of application no coloration of the skin was observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a OECD guideline compliant primary skin irritation test in rabbits neither erythema nor edema were observed 1, 24, 48 and 72 hours after application of the test substance. Therefore, the test item has to be regarded as not irritating to skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. No effects were observed after occlusive application of a 50 % solution in PEG/saline (70:30) of 0.5 g to the intact skin 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 after removal of the dressing. No destructions, irreversible/reversible alterations or coloration of the treated skin were observed at any animal at any measuring interval.
Thus, the test item did not induce significant or irreversible damage to the skin.
Therefore, the test item has not to be classified as "skin irritation" according to Regulation (EC) 1272/2008.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well performed guideline study according to OECD 405
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 kg to 3.0 kg
- Housing: Individually in stainless steel cages equipped with an automatic drinking water supply and cleaning system
- Diet (e.g. ad libitum): standard rabbit maintenance feed Kliba 23/341/1, Klingentalmuehle AG ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 2°C (air-condition)
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- One administration
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eye remained untreated and served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: in 3 out of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.
The eyes were examined and the grade of ocular reactions recorded at 1, 24, 48 and 72 hours after treatment and at 7, 14 and 21 days after treatment, unless the eye is normal at 72 hours, 7 or 14 days. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of six animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of six animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals (eyes not rinsed)
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- other: grade 1 chemosis was observed in all animals at 1 hour and was fully reversible after 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of tree animals (eyes rinsed)
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: grade 1 chemosis was observed in 2 anmials at 1 hour and was fully reversible after 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals (eyes not rinsed)
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- other: grade 1 redness was observed in 2 animals at 1 hour and was fully reversible after 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals (eyes rinsed)
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- other: grade 1 redness was observed in 2 animals at 1 hour and was fully reversibel after 48 hours.
- Irritant / corrosive response data:
- No corrosion effect was observed at each of the measuring intervals.
- Other effects:
- no coloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to compound effects.
No acute toxicological signs were observed in the animals during the test period. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to a OECD test guideline No. 405. 100 mg test item was inserted into the conjunctival sac of the left eye of 3 male and 3 female young adult New Zealand White rabbits respectively. In the female animals approximately 30 seconds after treatement the treated eyes were flushed with physiological saline for about one minute. The eyes of the male animals were not rinsed. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.
The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iritis, redness and chemosis of the conjunctivae. The individual mean scores for corneal opacity and iritis was 0.0 for all animals. Mean scores for the conjunctivae were 0.33 for reddening and 0.22 for chemosis (males). The mean score for the females was 0.1 for conjunctiva reddening.
All observed effects were reversible within 48 hours. No corrosion was observed at any of the measuring intervals. No clinical signs of toxicity were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.
Reference
individual results:
animal sex |
treatment of eye |
time |
cornea opacity |
iris |
conjunctiva redness |
conjunctiva chemosis |
55 male |
not rinsed |
1 h |
0 |
0 |
2 |
1 |
56 male |
not rinsed |
0 |
0 |
1 |
1 |
|
57 male |
not rinsed |
0 |
0 |
2 |
1 |
|
58 female |
rinsed |
0 |
0 |
0 |
0 |
|
59 female |
rinsed |
0 |
0 |
1 |
1 |
|
60 female |
rinsed |
0 |
0 |
1 |
1 |
|
55 male |
not rinsed |
24 h |
0 |
0 |
1 |
1 |
56 male |
not rinsed |
0 |
0 |
1 |
0 |
|
57 male |
not rinsed |
0 |
0 |
1 |
1 |
|
58 female |
rinsed |
0 |
0 |
0 |
0 |
|
59 female |
rinsed |
0 |
0 |
1 |
0 |
|
60 female |
rinsed |
0 |
0 |
0 |
0 |
|
55 male |
not rinsed |
48 h |
0 |
0 |
0 |
0 |
56 male |
not rinsed |
0 |
0 |
0 |
0 |
|
57 male |
not rinsed |
0 |
0 |
0 |
0 |
|
58 female |
rinsed |
0 |
0 |
0 |
0 |
|
59 female |
rinsed |
0 |
0 |
0 |
0 |
|
60 female |
rinsed |
0 |
0 |
0 |
0 |
|
55 male |
not rinsed |
72 h |
0 |
0 |
0 |
0 |
56 male |
not rinsed |
0 |
0 |
0 |
0 |
|
57 male |
not rinsed |
0 |
0 |
0 |
0 |
|
58 female |
rinsed |
0 |
0 |
0 |
0 |
|
59 female |
rinsed |
0 |
0 |
0 |
0 |
|
60 female |
rinsed |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification
The test material did not cause any irritant effecte on skin or eyes in vivo
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.