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EC number: 223-055-4 | CAS number: 3710-84-7
- 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
The skin sensitizer potential of diethylhydroxylamine was evaluated in a test performed according to the Buehler method (Shapiro, 1989).After establishing the highest non-irritating dose concentration, a 3 week induction period was initiated during which 10 young adult, male, guinea pigs were treated with diethylhydroxylamine applied as a 30% w/w solution in deionized water and 10 were treated with 0.08% dinitrochlorobenzene (DNCB) in 95% ethyl alcohol (positive controls).During the induction period the animals were dosed on alternate days until a total of nine dose applications was achieved. Seventeen days after the ninth application a challenge dose (30%) was applied to a naive site on each guinea pig and approximately 24 and 48 hours later the animals were scored for a sensitization response (erythema and edema). By the 4th induction many diethylhydroxylamine -treated animals exhibited very mild erythema at both 24 and 48 hours post-dose. A slight increase in the severity of irritation was noted at several sites after inductions 8 and 9. In positive control animals (0.08% DNCB), varying degrees of erythema were observed throughout induction, increasing in severity toward the end of this period. No irritation was noted after challenge in diethylhydroxylamine-treated animals.and naive control animals. In positive control animals, 24 and 48 hours after challenge all sites were erythemic, showing a faint to moderate response.It was concluded that diethylhydroxylamine was not a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was not validated at the time the Buehler assay was performed.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, S Brunewick, NJ, USA
- Age at study initiation: no data
- Weight at study initiation: 285-394 g
- Housing: gang-caged in suspended stailess cages with mesh floor
- Diet: ad libitum:
- Water: ad libitum
- Acclimation period: 4 or 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 67-77 °F
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 30%
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%
- No. of animals per dose:
- 10 treated + 5 control
- Details on study design:
- After establishing the highest non-irritating dose concentration, a 3 week induction period was initiated during which 10 young adult, male, guinea pigs were treated with the test material applied as a 30% w/w solution in deionized water and 10 were treated with 0.08% Dinitrochlorobenzene (DNCB) in 95% ethyl alcohol (positive controls). During the induction period the animals were dosed on alternate days until a total of nine dose applications was achieved. Seventeen days after the ninth application a challenge dose was applied to a naive site on each guinea pig and approximately 24 and 48 hours later the animals were scored for a sensitization response (erythema and edema). A naive control group of five animals was maintained under the same environmental conditions and was treated with the test material at challenge only.
- Positive control results:
- The positive response to 0.08% DNCB (positive control) validates the test system used in this study.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.08%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.08%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- not determinable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on these findings Pennatop PF 1866 is considered to be a non contact sensitizer when applied as a 30% w/w solution in deionized water, 3 times a week for 3 weeks.
- Executive summary:
The skin sensitizer potential of diethylhydroxylamine was evaluated in a test performed according to the Buehler method (Shapiro, 1989).After establishing the highest non-irritating dose concentration, a 3 week induction period was initiated during which 10 young adult, male, guinea pigs were treated with diethylhydroxylamine applied as a 30% w/w solution in deionized water and 10 were treated with 0.08% dinitrochlorobenzene (DNCB) in 95% ethyl alcohol (positive controls).During the induction period the animals were dosed on alternate days until a total of nine dose applications was achieved. Seventeen days after the ninth application a challenge dose (30%) was applied to a naive site on each guinea pig and approximately 24 and 48 hours later the animals were scored for a sensitization response (erythema and edema). By the 4th induction many diethylhydroxylamine -treated animals exhibited very mild erythema at both 24 and 48 hours post-dose. A slight increase in the severity of irritation was noted at several sites after inductions 8 and 9. In positive control animals (0.08% DNCB), varying degrees of erythema were observed throughout induction, increasing in severity toward the end of this period. No irritation was noted after challenge in diethylhydroxylamine-treated animals.and naive control animals. In positive control animals, 24 and 48 hours after challenge all sites were erythemic, showing a faint to moderate response.It was concluded that diethylhydroxylamine was not a skin sensitizer.
Reference
All guinea pigs appeared active and healthy throughout the
test period. There were no signs of gross toxicity, adverse
pharmacologic effects or abnormal behavior. All animals
gained weight.
INDUCTION PHASE :
. Test Animals: By the 4th induction many animals exhibited
very mild erythema at both 24 and 48 hours post-dose. A
slight increase in the severity of irritation was noted at
several sites after inductions 8 and 9.
. Positive Control Animals (0.08% DNCB): Varying degrees of
erythema were observed throughout induction, increasing in
severity toward the end of this period.
CHALLENGE PHASE:
. Test Animals: No irritation was noted after challenge.
. Naive Control Animals: No irritation was noted after
challenge.
. Positive Control Animals (0.08% DNCB): Twenty-four and 48
hours after challenge all sites were erythemic, showing a
faint to moderate response.
The incidence and severity of irritation (sensitization
response) after challenge are described below:
Sensitization Response
-----------------------------------
Incidence Severity
------------- -------------
24 hrs. 48 hrs. 24 hrs. 48 hrs.
Test Animals 0/10 0/10 0 0
Positive Control Animals 10/10 10/10 1.5 0.85
Naive Animals 0/5 0/5 0 0
-----------------------------------------------------------------
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitization: No classification according to CLP and GHS criteria.
In a test performed following the Buehler's method, DEHA was not a skin sensitizer. On the basis of this study and in accordance with Regulation (EC) No 1272/2008, DEHA does not merit classification as skin sensitizer.
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