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Diss Factsheets
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EC number: 214-122-9 | CAS number: 1087-21-4
- 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
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Endpoint summary
Administrative data
Description of key information
Studies used were read across from DAP a closely related structural analogue. Full justification given in Attachment. Indicate that DAIP is not irritating to skin or eyes.
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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- ANALOGUE APPROACH JUSTIFICATION
Please refer to attached document. - Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- 72h
- Number of animals:
- No data
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.29
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Study is interpretable but conclusions should be amended in context of OECD guideline 404.
Reference
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:
- Date of Study Report: August 9, 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given : Comparable to quidelines/standards
- Justification for type of information:
- ANALOGUE APPROACH JUSTIFICATION
Please refer to attached document. - Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Deviations:
- yes
- Remarks:
- : The test procedure was modified as follows: In Group I, Six rabbits; eyes unwashed following the instillation of the test material. In Group II, Three rabbits; eyes washed 4 seconds following instillation of the test material.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Washout after 4s, no information on a preliminary in vitro study
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml or 0.1g - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- All eyes were observed and ocular reaction recorded at 24, 48, and 72 hours after instillation of the test material. They were observed again after 7 days.
- Number of animals or in vitro replicates:
- Group I: 6 rabbits with eyes unwashed following the instillation of the test material
Group II: 3 rabbits with eyes washed for 4 seconds following instillation of the tests material - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent .
- Time after start of exposure: after the 24-hour reading.
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Group I : Conjunctival effects were observed in four animals. These effects cleared during the 72-hour observation period.
Group II : Conjonctival effects were observed in all three animals. These effects cleared during the 48-hour observation period. - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- On the basis of the data presented herein the following is concluded for the test material, FMC Corporation; D.A.P. (1 Qt. Net Wt.); C-8013-3:
Group I and II: It is a mild transient irritant to the rabbit eye when not followed by or followed by a washout 4 -seconds after instillation of the test material.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Although the studies used for assessing the potential of DAP to cause irritation of both eye and skin are not reliable without restrictions, they provide relevant and consistent data indicating that DAP is only slightly irritant to both skin and eye. In the interest of both sound science and animal welfare, further in vivo testing should not be considered necessary.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Based on the data presented here, DAP and threfore DAIP is not to be classified as irritant to either skin or eye. In extrapolation to humans, it can be safely concluded that DAP is not irritant to the human skin or eye. In many cases the albino rabbit is more sensitive than humans to ocular irritants or corrosives. There are also no known reports of irritation of human skin or eye after accidental exposure, which is consistent with the animal studies and provides further indications that classification for skin or eye irritation is not needed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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