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EC number: 473-310-0 | CAS number: 478385-88-5
- 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 in vivo, OECD TG 404: not
irritating (reference 7.3.1 -1)
Eye irritation in vivo, OECD TG 405: not irritating (reference 7.3.2 -1)
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:
- 2003-07-16 to 2003-07-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Age at study initiation: about 15 weeks
- Weight at study initiation: 3.08 kg (3.05 - 3.13 kg)
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 35 - 60 %
- Air changes: not specified
- Photoperiod:12 / 12 hrs dark / hrs light
The room temperature and relative atmospheric humidity in the animal room was transiently outside the target range of 16 to 22 °C and > 40 %. This deviation did not influence the integrity of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours after removal of patches
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap: The patch was fastened to the left side of the animal's back and kept in place by a self-adhesive fabric.
REMOVAL OF TEST SUBSTANCE
- Washing: wiping off dry
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS : The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8. Body weight was recorded on experimental days 1 and on experimental days 5 and 8.
SCORING SYSTEM: According to Draize
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Clinical findings
After a single application to the intact dorsal skin of rabbits, for a 4 hours period of exposure under semiocclusive conditions, no signs of irritation were observed in the treated areas.
No signs of clinical toxicity were detected. - Other effects:
- Mortality
All animals survived the observation period.
Body weight
Body weight development of the treated rabbits was inconspicuous. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected, thus the test material is not considered to be a skin irritant.
- Executive summary:
The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with 2 further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
Under the conditions of the present study no signs of irritation were seen. The evaluation of the mean scores yields zero at all time points investigated.
In conclusion, no skin irritating potential could be detected, thus the test material is not considered a skin irritant.
Reference
Table 1 Individual local findings
Animal No. |
|
Local findings on day |
|||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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:
- 2006-09-05 to 2006-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Age at study initiation: about 37 weeks
- Weight at study initiation: 5.62 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 20 °C
- Humidity: 47 - 75 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to Draize
- Preparation: Before the application, the test material was ground in a mortar using a pestle.
- Administration and dose level: To ensure that only rabbits with normal eyes were included in the study, approximately 24 hours before treatment ophthalmological examinations were performed after instillation of a 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope according to Eisenhut (Basel). Animals with eye defects, injury or irritation were excluded. 0.1 g test material was instilled into the conjunctival sac of the left eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was placed. The right eye remained untreated and served as control. After instillation, the eyelids were closed for about 30 seconds.
- Observation for clinical symptoms
The rabbits were examined for eye irritation and for changes in behavior and general condition 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part. Eye changes were evaluated according to the DRAIZE- , OECD- and EEC recommendations.
- Body weight
Body weight was recorded on days 1, 5, and 8, of the experimental part. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of irritation were observed at the cornea or iris. One hour after treatment the conjunctivae showed only discharge (score 1). Thereafter no signs of irritation were observed.
The confirmatory test with two further animals showed no signs of irritation at the cornea or iris. One hour and 24 hours after treatment the conjunctivae showed redness (score 1) in two animals. Furthermore discharge (score 1) was seen in both animals one hour after treatment. Thereafter, no signs of irritation were observed. - Other effects:
- - Clinical signs
No signs of clinical toxicity were detected.
- Mortality
All animals survived the observation period.
- Body weight
Body weight development of the treated rabbits was inconspicuous. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No eye irritating potential could be detected, thus the test material is considered to be not an eye irritant.
- Executive summary:
The purpose of this primary eye irritation assay was to provide information on possible health hazards in case of acute eye contact with a test material and serve as a a rational basis for risk assessment to the eye irritating potential of the test item in man. To test for eye irritation a test according to the OECD-Guidelines for Testing of Chemicals No. 405, the annex to Directive 92/69 EEC, and the recommendations of DRAIZE (1959) was performed. No signs of irritation were observed at the cornea or iris. One hour and 24 hours after treatment, the conjunctivae showed redness (score I) in two animals. Furthermore, discharge (score I) was seen one hour after treatment. Thereafter no signs of irritation were observed. The untreated eyes were unchanged. No eye irritating potential could be detected, thus the test material is considered to not be an eye irritant.
Reference
Table 1 Individual findings
Animal |
Day |
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
No. |
Hour(s) |
|
(1) |
(24) |
(48) |
(72) |
|
|
|
|
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
C |
1 |
0 |
0 |
0 |
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
Skin irritation in vivo (reference 7.3.1.-1)
In a primary dermal irritation study, young
adult New Zealand White rabbits (3 females) were dermally exposed to 0.5
g of moistened test material for 4 hours under semiocclusive conditions.
Animals then were observed 1, 24, 48 and 72 hours, as well as 7 days
after treatment. No erythema and no edema irritation were observed
within the course of the observation period. The cumulative irritation
score was 0.00 based on the DRAIZE scheme indicating no irritant
potential. In this study, the test material was not a dermal irritant.
Eye irritation in vivo (reference 7.3.2 -1)
In a primary eye irritation study 0.1 g of the test material was instilled into the conjunctival sac of the left eye of young adult New Zealand White rabbits (3 females). Animals then were observed 1, 24, 48 and 72 hours, as well as 7 days after treatment.
No signs of irritation were observed at the cornea or iris. One hour and 24 hours after treatment, the conjunctivae showed redness (score I) in two animals. Furthermore, discharge (score I) was seen one hour after treatment. Thereafter no signs of irritation were observed. The untreated eyes were unchanged. In this study, the test material was not an eye irritant.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data the test item does not require classifcation as skin or
eye irritant according to Regulation (EC) No 1272/2008 (CLP), as amended
for the twelfth time in Regulation (EU) 2019/521.
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