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EC number: - | 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
Skin irritation:
A primary skin irritation study (Simon, 2008) is available which is key study. This study showed the test substance is not irritating to rabbit skin.
Eye irritation:
A primary eye irritation study (Simon, 2008) is available which is key study. This study showed the test substance is not irritating to rabbit eye.
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:
- From 05 to 13 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
- 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: Harlan Netherlands BV
- Age at study initiation: 12 weeks
- Weight at study initiation: 2355g, 2322g, 2447g
- Fasting period before study:
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum.
- Water (e.g. ad libitum): Community tap water from Fullinsdorf ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
IN-LIFE DATES: From: 05 December 2007 To: 13 December 2007 - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- one male and two females
- Details on study design:
- TEST SITE
- Area of exposure: 100 cm2 (10cm×10cm)
- % coverage:
- Type of wrap if used: The patch was covered with a semi-occlusive dressing which was wrapped around the abdomen and anchored with tap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize score system
Any other information of method:
Observations
Mortality/Viability: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Skin Reaction: The skin reation was assessed at approximately 1, 24, 48 and 72 hours after exposure. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritant / corrosive response data:
- Irritation: 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 test item did not elicit any skin reactions at the application site of any animal at any of the observation time. The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Corrosion: Neither alterlations of the treated skin were observed nor were corrosive effects evident on the skin. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be “not irritating” to rabbit skin.
Reference
Viability/Mortality/Clinical Signs: No clinical signs of systemic toxicity were observed in the animal during the study and no mortality occurred.
Coloration: No staining produced by the test item of the treated skin was observed.
Body Weights
Body weight in grams |
||||
Animal No. |
Sex |
First day of Acclimatization |
Day of Treatment |
Last Day of Observation |
70 |
male |
2128 |
2355 |
2536 |
71 |
female |
2167 |
2322 |
2471 |
72 |
female |
2304 |
2447 |
2547 |
Skin Irritation Scores-Individual Values
Animal Number |
Sex |
Evaluation Interval |
Erythema |
Oedema |
Cumulative |
|
Score |
Mean |
|||||
70 |
M |
1 hour |
0 |
0 |
0.00 |
0.00 |
71 |
F |
0 |
0 |
0.00 |
||
72 |
F |
0 |
0 |
0.00 |
||
70 |
M |
24 hours |
0 |
0 |
0.00 |
0.00 |
71 |
F |
0 |
0 |
0.00 |
||
72 |
F |
0 |
0 |
0.00 |
||
70 |
M |
48 hours |
0 |
0 |
0.00 |
0.00 |
71 |
F |
0 |
0 |
0.00 |
||
72 |
F |
0 |
0 |
0.00 |
||
70 |
M |
72 hours |
0 |
0 |
0.00 |
0.00 |
71 |
F |
0 |
0 |
0.00 |
||
72 |
F |
0 |
0 |
0.00 |
M: male; F: female
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:
- From 03 to 16 January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- 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: 13 weeks (male), 12-13 weeks (females)
- Weight at study initiation: No.67: 2991g, No.68: 2538g, No.69: 2690g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): Air-conditioned with 10-15 air change her hour
- Photoperiod (hrs dark / hrs light): automatically controlled lighte cycle of 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 03 January 2008 To: 16 January 2008 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per animal
- 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:
- Single instillation, eye unwashed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- One male, two females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Commission Directive 2004/73/EC, April 29, 2004
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
The eyes of each animal were examined approximately 1, 24, 48, 72 hours, as well as 7 days after administration. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 0.89
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Two animals were reversible with 72 hours and one reversible within 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Two animals were reversible with 24 hours and one reversible within 72 hours.
- Irritant / corrosive response data:
- 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 the animals. The individual mean scores for the conjunctivae were 0.67, 1.33 and 0.67 for reddening and 0.00, 0.67 and 0.00 for chemosis, respectively.
A very slight opacity affecting the whole was observed in both females 1 hour after instillation.
A moderate reddening of the conjunctivae was noted in all animals at the same observation time point and persisted as slight up to the 48- and 72- hour reading, respectively. Additionally, a slightly to obvious swelling of the conjunctivae with partial eversion of lids was observed in all animals at the 1- hour observation and persisted as slight up to the 48- hour evaluation in the first treated female.
A slight to moderate reddening of the sclera was present in the three animals 1 hour after treatment and persisted as slight up to the 24- and 72- hour reading, respectively.
Slight to moderate ocular discharge was present in all animals 1 hour after instillation.
No abnormal findings were observed in the treated eye of any animal 72 hours of 7 days after treatment.
No corrosion of the cornea was observed at any of the reading times. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be not irritating to the rabbit eye.
Reference
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated eye was observed.
Brown test item remnants were evident in the eye or conjunctival sac of all animals 1 hour after instillation and persisted up to the 24- or 48- hour reading in both females.
The body weights of all rabbits were considered to be within the normal range of variability.
Body weight in grams |
||||
Animal No. |
Sex |
First Day of Acclimatization |
Day of Treatment |
Last Day of Observation |
67 |
male |
2700 |
2991 |
3238 |
68 |
female |
2419 |
2538 |
2784 |
69 |
female |
2284 |
2690 |
2966 |
Eye Irritation Scores- Individual Values
Animal Number |
Sex |
Evaluation Interval |
Corneal Opacity |
Area of Corneal Opacity |
Iris |
Conjunctivae |
Sclera |
|
Redness |
Chemosis |
|||||||
67 68 69 |
M F F |
1 hour |
0 1 1 |
0 4 4 |
0 0 0 |
2 2 2 |
1 2 1 |
2 2 1 |
67 68 69 |
M F F |
24 hours |
0 0 0 |
0 0 0 |
0 0 0 |
1 2 1 |
0 1 0 |
1 1 1 |
67 68 69 |
M F F |
48 hours |
0 0 0 |
0 0 0 |
0 0 0 |
1 1 1 |
0 1 0 |
0 1 0 |
67 68 69 |
M F F |
72 hours |
0 0 0 |
0 0 0 |
0 0 0 |
0 1 0 |
0 0 0 |
0 1 0 |
67 68 69 |
M F F |
7 days |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
A primary skin irritation study was conducted according to OECD 404 using rabbits (Simon, 2008). Key study.
This study showed the test substance is not irritating to rabbit skin.
Eye irritation:
A primary eye irritation study was conducted according to OECD 405 using rabbits (Simon, 2008). Key study.
This study showed the test substance is not irritating to rabbit eye.
Justification for selection of skin irritation / corrosion endpoint:
This study was conducted according to OECD 404 under GLP.
Justification for selection of eye irritation endpoint:
This study was conducted according to OECD 405 under GLP.
Justification for classification or non-classification
Skin irritation/corrosion: Mean scores at 24, 48 & 72 hours for erythema were < 2.3 (actual value 0) for oedema were < 2.3 (actual value 0). In addition all reactions were fully reversible within the observation period (actual value within 72 hours).
Serious eye damage/eye irritation: Mean scores at 24, 48 & 72 hours for corneal opacity were < 1 (actual value 0), for iritis were < 1 (actual value 0), for conjunctival redness were < 2 (actual value 0.89) and for conjunctival oedema were < 1 (actual value 0.22).
Therefore in accordance with Regulation (EC) No. 1272/2008 Tables 3.2.2 & 3.3.2 the substance is not classified for the skin corrosion/irritation and serious eye damage/eye irritation endpoint.
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