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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
In 4 in vivo studies performed before the adoption of OECD 404, the skin irritation potential of the substance and of solutions of the substance was investigated. The only effect that was reported was slight erythema directly after patch removal, which reversed within 48 hours.
In 7 in vivo studies, performed similar to OECD 405 (1981), the eye irritation potential of the substance and of solutions of the substance was investigated. As reversibility could not be observed in all animals, the substance should be classified according to Regulation EC 1272/2008 with category 1, H318 "Causes serious eye damage". Based on the results obtained with solutions of the substance, ≤ 43% solutions of the substance (solid content ≤ 16%) do not need to be classified for eye irritation according to the criteria of the CLP Regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
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:
- June 15, 1988 - June 29, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed similar to OECD 405 (1981) and according to GLP principles. However, as the observation period stopped on day 7, the reversibility could not be fully assessed.
- Qualifier:
- according to guideline
- Guideline:
- other: modification of the Code of Federal Regulations 1500-42 (1985)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- the observation period of only 7 days instead of up to 21 days was not sufficient to evaluate the reversibility or irreversibility of the effects observed, and the ocular lesions were not scored 1 hour after installation
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA
- Age at study initiation: no data (but reported to be young adults)
- Weight at study initiation: 2.30 - 2.62 kg
- Housing: suspended wire mesh cages
- Diet: Purina rabbit pellets (ad libitum)
- Water: ad libitum
- Acclimation period: minimum period of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 72 ± 5 degrees F (22.2 ± 5 °C)
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark/12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye served as the control
- Amount / concentration applied:
- TEST MATERIAL (applied as such)
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Not applicable (the eyes were not rinsed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (2 females and 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM: similar to OECD 405
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- See section "Any other information on results incl. tables"
- Other effects:
- See section "Any other information on results incl. tables"
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, performed similar to OECD 405 (1981) and according to GLP principles, the substance (solid content 38-40%) is classified as causing serious eye damage (Category 1) according to the criteria of the CLP Regulation.
- Executive summary:
The substance was tested for acute ocular irritation in 2 females and 1 male New-Zealand White rabbits, similar to OECD 405 and according to GLP principles. The test material (solid content: 38-40%), was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of each animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 24, 48, 72 hours and 4 and 7 days after the instillation. Grade 2 corneal opacity was observed in 2 animals at 24 hours, lasting up to 72 hours in 1 animal. It persisted in the other animal throughout the 7 day observation period. In this same animal, conjunctival redness (grade 1, 2 and 3), conjunctival chemosis (grade 1 and 2) and iris inflammation (grade 1) persisted also throughout the observation period. In the other 2 animals the effects (grade 1 and 2) reversed within the observation period. As reversibility could not be observed in 1 animal in this study, the substance should be classified according to Regulation EC 1272/2008 with category 1, H318 "Causes serious eye damage".
Reference
Animal number and sex |
Parameter |
Hours after instillation |
Days after instillation |
|||
24 |
48 |
72 |
4 |
7 |
||
7907 Male |
Cornea (opacity) |
1 |
1 |
0 |
0 |
0 |
Cornea (area) |
1 |
1 |
0 |
0 |
0 |
|
Iris |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
1 |
1 |
0 |
0 |
|
Conjunctivae (chemosis) |
2 |
1 |
1 |
0 |
0 |
|
Conjunctivae (discharge) |
2 |
1 |
0 |
0 |
0 |
|
7908 Female |
Cornea (opacity) |
2 |
2 |
2 |
2 |
2 |
Cornea (area) |
not scored |
|||||
Iris |
1 |
1 |
1 |
0 |
1 |
|
Conjunctivae (redness) |
3 |
3 |
2 |
1 |
2 |
|
Conjunctivae (chemosis) |
2 |
2 |
1 |
1 |
2 |
|
Conjunctivae (discharge) |
2 |
2 |
1 |
1 |
2 |
|
7909 Female |
Cornea (opacity) |
2 |
2 |
2 |
1 |
0 |
Cornea (area) |
2 |
2 |
1 |
1 |
0 |
|
Iris |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae (redness) |
2 |
2 |
1 |
1 |
0 |
|
Conjunctivae (chemosis) |
2 |
1 |
1 |
1 |
0 |
|
Conjunctivae (discharge) |
2 |
2 |
1 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In 4 in vivo studies performed according to Code of Federal Regulations 21, Part 191.1 (g) (2), 191.11, before the adoption of OECD 404, the skin irritation potential of the substance and of solutions of the substance was investigated. The rabbits were exposed to 0.5 mL of test material as is (2 studies) or to 0.5 mL of dilutions of test material (2 studies) for 24 hours under occlusive conditions. The only effect that was reported was slight erythema directly after patch removal, which reversed within 48 hours.
As the conditions under which the studies were performed were more severe than prescribed by OECD 404 (24 hours occlusive exposure instead of 4 hours semi-occlusive exposure), the studies are regarded as reliable information for assessing the skin irritation hazard of the substance and an additional study for investigating the skin irritation potential of the substance is not regarded to be needed. Although there is no study available for the substance performed according to a method referred to in REACH article 13(3), it is considered justified to conclude based on the existing data and a weight of evidence approach that further testing is not scientifically necessary, as when the available studies are compared with the in vivo method referred to in REACH article 13(3):
- The exposure duration was longer (24 hours instead of 4 hours)
- The exposure condition was more severe (occlusive instead of semi-occlusive)
- The skin was abraded
- There were little or no effects observed, that reversed within the observation period, making it questionable whether performing more effect readings would have been of any use for classification purposes according to the CLP Regulation (as the observed effects were reversed within 48 hours).
In addition, there is no specific alert or concern raised in the existing data or uncertainty on the scores reported that would require further investigation.
Eye irritation
In 7 in vivo studies, performed similar to OECD 405 (1981), the eye irritation potential of the substance as registered (in 3 studies) and of aqueous dilutions of the substance was investigated (in 4 studies). In the 3 studies with the undiluted substance, the intensity of effects were always below the criteria of severe effects, however reversibility could not be observed in all animals due to the limited observation period after exposure (observation period stopped on day 7 in 2 studies, or 72 hours in 1 study).
Based on the results obtained with solutions of the substance, ≤ 43% solutions of the substance (solid content ≤ 16%) do not need to be classified for eye irritation according to the criteria of the CLP Regulation.
Justification for selection of skin irritation / corrosion endpoint:
As the endpoint conclusion is based on a weight of evidence approach, no study has been selected.
Justification for selection of eye irritation endpoint:
The key study
Effects on eye irritation: corrosive
Justification for classification or non-classification
Skin irritation
As in 4 in vivo studies only slight erythema directly after patch removal was reported, which reversed within 48 hours, the substance does not need to be classified for skin irritation in accordance with the CLP Regulation.
Based on the limited reactions observed in the available studies with the aqueous solutions, the solid (surfactant) fraction is not expected to be a skin irritant.
Eye irritation
As in the 3 in vivo studies with the undiluted substance the full reversibility could not be demonstrated in all animals during the observation period, a worst-case classification is applied and the substance is classified according to Regulation EC 1272/2008 with category 1, H318 "Causes serious eye damage".
Based on the results obtained in the 4 in vivo studies with dilutions of the substance, ≤ 43% solutions of the substance (solid content ≤ 16%) do not need to be classified for eye irritation according to the criteria of the CLP Regulation.
The substance is considered cat.1, H318 "Causes serious eye damage" for concentrations ≥ 40% (rounded value).
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