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EC number: 223-276-6 | CAS number: 3806-34-6
- 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
Skin; not irritating; rabbit; Federal Register Vol. 41 No. 118 (1976) p. 42572; Levi (1977)
Eye; not irritating; rabbit (10% w/v solution); Federal Register Vol. 29 No. 182 (section 191.12 (a) (1) and (2)) p. 13009; Moldovan (1971)
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:
- supporting study
- Study period:
- 13 Decmber 1977 to 15 December 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register Vol. 41No. 118 (1976) p. 42572
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only observations for ulceration and necrosis were performed. Observations were performed only up to 48 hours.
- Principles of method if other than guideline:
- 0.5 g of test material was applied to the skin of 6 male rabbits for 4 hours. At the end of the exposure period, the test material was removed and skin reactions recorded over the 48 hour study period.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 48 hours
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: Hair was clipped from the abdomen of the animals.
- Type of wrap: Test material was placed on the skin under a small square of cotton gauze, held in place with a larger square of polyethylene film secured with strips of adhesive tape. A square of flannel cloth was then taped around the trunk of the animal to further protect the patches from being dislodged.
REMOVAL OF TEST SUBSTANCE
After 4 hours the vest and patches were removed and the skin examined for signs of irritation. The test site was washed with an appropriate solvent to prevent further exposure.
SCORING SYSTEM: Corrosion was considered to have resulted if the test material caused destruction or irreversible alteration of the tissue. Tissue destruction was considered to have occurred if, at any of the readings, there was ulceration or necrosis. Tissue destruction did not include sloughing of the epidermis, or erythema, oedema, or fissuring. - Interpretation of results:
- other: Not possible to classify based on the available information
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Application of the test material to the skin of rabbits produced no necrosis or ulceration up to 48 hours after 4 hours under occlusive exposure.
- Executive summary:
The skin corrosivity of the test material was investigated following the method outlined in Federal Register Vol. 41, No. 118 (1976) p 42572. During the study, 0.5 g test material was applied to the skin of 6 rabbits, under an occlusive dressing, for a period of 4 hours. After 4 hours, the test material was removed from the test site and skin reactions recorded. A further evaluation of skin reaction occurred at 48 hours. Under the conditions of the study application of the test material to the skin of rabbits produced no necrosis or ulceration.
Reference
Table 1: Skin Corrosivity - Individual Reactions
Animal number |
4 hours |
48 hours |
||
Necrosis |
Ulceration |
Necrosis |
Ulceration |
|
1495 |
no |
no |
no |
no |
1496 |
no |
no |
no |
no |
1497 |
no |
no |
no |
no |
1498 |
no |
no |
no |
no |
1519 |
no |
no |
no |
no |
1520 |
no |
no |
no |
no |
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:
- Not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data. The amount of test material instilled into the eye is not reported.
- Qualifier:
- according to guideline
- Guideline:
- other: Section 191.12 (a) (1) and (2) of Federal Register Vol. 29 No. 182 p. 13009
- Deviations:
- no
- Principles of method if other than guideline:
- Test material, as a 10 % w/v suspension in cottonseed oil, was instilled into the right eye of each of 6 rabbits. The left eye served as the control and was instilled with cottonseed oil only. Eye reactions were scored over a period of 72 hours following exposure.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- other: cottonseed oil
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Test material was tested as a suspension in cottonseed oil. Prepared by dissolving 1 g test material in methylene chloride then adding 10.0 mL of cottonseed oil, and evaporating the solvent on a steam bath.
- Concentration (if solution): 10 % w/v - Duration of treatment / exposure:
- Animals recieved a single treatment of test material suspension
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.11
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: (no effects)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: (no effects)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: (no effects)
- Irritant / corrosive response data:
- The test material produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material only produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.
- Executive summary:
The eye irritation potential of the test material was investigated according to the method described under Section 191.12 (a) (1) and (2) of the Federal Register Vol. 29 No. 182 (1964) p. 13009. During the study, test material, as a 10% w/v suspension in cottonseed oil, was instilled into the right eye of each of 6 rabbits. The left eye served as the control and was instilled with cottonseed oil only. Eye reactions were scored over a period of 72 hours following exposure. Under the conditions of the study, the test material only produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.
Reference
Table 2: Individual daily scores
Tissue |
Right eye (treated) |
Left eye (control) |
||||||
Day |
||||||||
1 |
2 |
3 |
1 |
2 |
3 |
|||
Rabbit No. 1 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rabbit No. 2 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rabbit No. 3 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rabbit No. 4 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rabbit No. 5 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
||
Rabbit No. 6 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
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 the key study, the skin corrosivity of the test material was investigated following the method outlined in Federal Register Vol. 41, No. 118 (1976) p 42572. During the study, 0.5 g test material was applied to the skin of 6 rabbits, under an occlusive dressing, for a period of 4 hours. After 4 hours, the test material was removed from the test site and skin reactions recorded. A further evaluation of skin reaction occurred at 48 hours. Under the conditions of the study application of the test material to the skin of rabbits produced no necrosis or ulceration. Therefore, the test material is not considered to be a corrosive agent.
Based on the dermal irritation observations reported in the most recent acute dermal toxicity study, and the results of the available in vivo corrosivity test, the available information is sufficient for classification and labelling and risk assessment purposes. Considering all the available information as part of an integrated testing strategy, as recommended by the OECD Guideline 404. The test material is considered to be neither corrosive, nor irritating to the skin.
Eye Irritation
The eye irritation potential of the test material was investigated according to the method described under Section 191.12 (a) (1) and (2) of the Federal Register Vol. 29 No. 182 (1964) p. 13009. During the study, test material, as a 10% w/v suspension in cottonseed oil, was instilled into the right eye of each of 6 rabbits. The left eye served as the control and was instilled with cottonseed oil only. Eye reactions were scored over a period of 72 hours following exposure. Under the conditions of the study, the test material only produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for skin or eye irritation.
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