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EC number: 219-553-6 | CAS number: 2461-15-6
- 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
It can be concluded that test substance possesses a cumulative skin irritation potential in albino rabbits.
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 October 1, 1984 to October 18, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well documented under GLP principle
- Principles of method if other than guideline:
- An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 mL/application of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were covered with an occlusive membrane and held in place for 6 hours by an adhesive tape. The treatment was repeated for 5 consecutive days. The skin reactions were evaluated 24 hours after each application.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animal Strain: New Zealand white rabbits (KFM-NZW)
Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
Acclimatization period: 5 days
Group Size and Husbandry: The test was performed on 3 male rabbits , checked for normal skin conditions, weighing between 2 to 3 kg (approx. 12 - 14 weeks old) . The animals were housed individually in metal cages, identified with individually numbered ear tags, kept at a constant room temperature of 20 ±3 °C, at a relative humidity of 30 - 70% and on a 12 hours light cycle per day. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral flank
- Amount / concentration applied:
- 0.5 mL/application of test substance
- Duration of treatment / exposure:
- held in place for 6 hours, repeated for 5 consecutive days
- Observation period:
- the observation period was extended to 17 days.
- Number of animals:
- 3 males
- Details on study design:
- An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 mL/application of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were covered with an occlusive membrane and held in place for 6 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The treatment was repeated for 5 consecutive days. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 24 hours after each application according to the OECD scoring system.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- see Table 1 and Table 2
- Other effects:
- No abnormal body weight gain was observed during the treatment period.
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Criteria used for interpretation of results: EU CLP
- Conclusions:
- It can be concluded that test substance possess a cumulative skin irritation potential in albino rabbits.
- Executive summary:
A 5-day skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of test substance on the albino rabbit skin. Under the experimental conditions employed, test substance induced weak erythema reactions after 1 treatment and strong erythema and edema reactions after repeated application comparing with control treatment. The skin reactions were reversible until the end of the observation period on day 17. Therefore, test substance can be classified as category 2 of skin irritation in the rats according to CLP (Regulation EC No. 1272/2008).
Reference
Table 1 Erythema
Animal No./sex |
28 M |
29M |
30M |
|||
|
CF |
TF |
CF |
TF |
CF |
TF |
After 1 days |
0 |
1 |
0 |
1 |
0 |
1 |
After 2 days |
0 |
2 |
0 |
2 |
0 |
2 |
After 3 days |
0 |
3 |
0 |
3 |
0 |
3 |
Mean 1-3 days |
0 |
2 |
0 |
2 |
0 |
2 |
After 4 days |
0 |
4 |
0 |
4 |
0 |
4 |
After 5 days |
0 |
4 |
0 |
4 |
0 |
4 |
Mean 1-5 days |
0 |
2.8 |
0 |
2.8 |
0 |
2.8 |
After 7 days |
0 |
2 |
0 |
3 |
0 |
3 |
After 10 days |
0 |
1 |
0 |
1 |
0 |
2 |
After 14 days |
0 |
0 |
0 |
0 |
0 |
0 |
After 17 days |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2 Edema
Animal No./sex |
28 M |
29M |
30M |
|||
|
CF |
TF |
CF |
TF |
CF |
TF |
After 1 days |
0 |
0 |
0 |
0 |
0 |
0 |
After 2 days |
0 |
2 |
0 |
1 |
0 |
2 |
After 3 days |
0 |
2 |
0 |
2 |
0 |
3 |
Mean 1-3 days |
0 |
1.3 |
0 |
1 |
0 |
1.66 |
After 4 days |
0 |
3 |
0 |
3 |
0 |
3 |
After 5 days |
0 |
3 |
0 |
2 |
0 |
3 |
Mean 1-5 days |
0 |
2 |
0 |
1.3 |
0 |
2.2 |
After 7 days |
0 |
2 |
0 |
3 |
0 |
3 |
After 10 days |
0 |
1 |
0 |
1 |
0 |
2 |
After 14 days |
0 |
0 |
0 |
0 |
0 |
0 |
After 17 days |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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 September 29, 1983 to October 10, 1983
- 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:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Experimental animals:
Rationale
The albino rabbit has been selected as being a recognized species for the conduct of acute eye irritation studies.
Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
Initial age range: 12 - 14 weeks
Initial body weight range: 2000 - 2310 g
Individual identification: numbered ear tags; The cages were marked with sex, animal No., GU-Project No. and the company code of the
test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20 ±3 ° C, relative humidity 30 - 70%; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were killed by the intravenous injection of hypnotic T61 (Hoechst). - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated and served as the control
- Amount / concentration applied:
- 0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- The ocular irritation scores were evaluated according to the scoring system.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.
Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
Body weight: At begin of the acclimatisation and end of test
Mortality: Daily (a.m. and p.m. on working days, once daily on weekends and holidays). - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- The reaction scores of treated eyes are summarized in the table 1 and table 2 below.
- Other effects:
- The animals showed a normal body weight development.
No other reactions to treatment were recorded during the whole observation period. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU CLP
- Conclusions:
- It can be concluded that test substance is slightly irritant and not corrosive when applied to the rabbit eye mucosa; there was a clear tendency of recovery towards the end of the observation period.
- Executive summary:
Acute eye irritation study was established to assess the potential of eye irritation of test substance. 0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period. The animals showed a normal body weight development. No other reactions to treatment were recorded during the whole observation period. Because the mean values of the readings 24 to 72 hours after instillation of test substance are below the threshold of significance, and there was a clear tendency of recovery towards the end of the observation period the test substance does not require classification for eye effects in accordance with CLP (Regulation EC No. 1272/2008).
Reference
Table 1 individual eye scores
Animal No./Sex |
54/F |
55/F |
56/F |
Evaluation |
After 1 h |
0 |
0 |
0 |
0= non irritant 1= slightly irritant 2= irritant 3-4 = severely irritant += corrosion Cornea |
After 24 h |
0 |
0 |
0 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
|
After 1 h |
0 |
0 |
0 |
0= non irritant 1= irritant 2= severely irritant += corrosion Iris |
After 24 h |
0 |
0 |
0 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
|
After 1 h |
1 |
2 |
2 |
0= non irritant 1= slightly irritant 2= irritant 3= severely irritant += corrosion Conjuctival(redness) |
After 24 h |
0 |
1 |
1 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
|
After 1 h |
1 |
1 |
1 |
0= no swelling 1= slightly swelling 2= swelling 3-4 = severe swelling Chemosis(swelling) |
After 24 h |
0 |
0 |
0 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
Table 2 Mean value of 24 -72 hrs
|
Cornea |
Iris |
conjuctiva |
chemosis |
54/F |
0 |
0 |
0 |
0 |
55/F |
0 |
0 |
0.33 |
0 |
56/F |
0 |
0 |
0.33 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The eye irritation study (1997) was established to assess the irritation potential of test substance in the rabbit eyes. 0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period. No other reactions to treatment were recorded during the whole observation period. There was a clear tendency of recovery towards the end of the observation period.
A 5-day skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of test substance on the albino rabbit skin. Under the experimental conditions employed, test substance induced weak erythema reactions after the first treatment and strong erythema and edema reactions after repeated application comparing with control treatment. The skin reactions were reversible until the end of the observation period on day 17. It can be concluded that test substance possess a cumulative skin irritation potential in albino rabbits. Therefore, test substance can be classified as category 2 of skin irritation in the rats according to CLP (Regulation No. 1272/2008).
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
The mean values of the readings 24 to 72 hours after instillation of test substance are below the threshold of significance in the eye irritation test, and there was a clear tendency of recovery towards the end of the observation period. Therefore, the test substance does not require classification for eye irritation in accordance with CLP (Regulation No. 1272/2008). However, based on the available result of a skin irritation study, the test substance can be classified as skin irritation category 2 under CLP.
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