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EC number: 448-250-3 | 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
Oral (OECD 423), rat: LD50 > 2000 mg/kg bw; LD50 cut-off value = 5000 mg/kg bw (limit test)
Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Jul - 08 Aug 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted June 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF) Nov. 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: female (mean) 230 ± 32 g; male (mean) 358 ± 19 g
- Fasting period before study: over night
- Housing: 3 animals per sex per cage in labelled Makrolon type IV cages containing purified sawdust as bedding material
- Diet: standard pelleted laboratory animal diet (Altromin, code VRF 1), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1 - 24.5
- Humidity (%): 47 - 79
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- The dose level of 2000 mg/kg bw was reached by administration of two times 1000 mg/kg bw (10 mL/kg bw) within 24 hours. The first on t=0 and the second on approx. t=1 hour.
VEHICLE
- Amount of vehicle (if gavage): Two administrations of formulation of the test substance at 10 mL/kg bw
- Justification for choice of vehicle: vehicle was selected based on trial formulations performed at the testing laboratory - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1st step: 3 females
2nd step: 3 males - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed twice daily. Animals were observed at periodic intervals on the day of dosing and once daily thereafter for clinical signs. Weighing was done prior to dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- No statistical analysis was performed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: According to OECD Guideline 423, Annex 2d, a cut-off value of 5000 mg/kg bw was derived based on a limit test with 2000 mg/kg bw, since no mortality occurred in any step.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Clinical signs were noted in all animals between days 1 and 3 and included lethargy, hunched posture, uncoordinated movements and piloerection in all animals. In addition, ptosis were noted in all males on day 1.
- Body weight:
- Body weight gain was normal during the study.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
Reference
Table 1. Table for acute oral toxicity
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
0/3/3 |
Day1 – Day2 |
--- |
0 |
Females |
||||
2000 |
0/3/3 |
Day1 – Day3 |
--- |
0 |
LD50 > 2000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Feb - 18 Feb 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- adopted June 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), November 2000, including most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: male (mean) 306 ± 14 g; female (mean) 216 ± 14 g
- Housing: individually in labelled Makrolon type III cages containing purified sawdust as bedding material
- Diet: standard pelleted laboratory animal diet (Altromin, code VRF1), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.4 - 22.9
- Humidity (%): 29 - 80
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 25 cm² for males and 18 cm² for females
- % coverage: 10
- Type of wrap if used: surgical gauze patch, successively covered with aluminium foil and Coban elastic bandage, for females bandages were fixed using a piece of micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance using water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Constant volume or concentration used: yes
- Concentration (if solution): 200 mg/mL (w/w) (calculated from 10 mL/kg bw amount and 2000 mg/kg bw)
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: checks were done twice daily for mortalities, clinical signs were recorded at periodic intervals on the day of dosing and once daily thereafter, body weights were determined before dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed during the study
- Mortality:
- No mortality occurred.
- Clinical signs:
- Flat/hunched posture and/or chromodacryorrhoea were noted among all animals between days 1 and 5.
- Body weight:
- Body weight gain was within the normal range during the study.
- Gross pathology:
- No toxicologically relevant abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- White staining of the treated skin area was noted among most animals between days 2 and 9. In addition, erythema (days 2 and/or 3) or scales (between days 3 and 12) of grade 1 were noted on the treated skin area of some females (table 2).
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
Reference
Table 1. Table for acute dermal toxicity
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
0/5/5 |
Day1 – Day5 |
--- |
0 |
Females |
||||
2000 |
0/5/5 |
Day1 – Day5 |
--- |
0 |
LD50 > 2000 mg/kg bw |
Day 1 refers to the day of test substance administration.
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Table 2. Presence of skin effects
|
Female rats |
Male rats |
||||||||
Animal no. |
1 |
2 |
3 |
4 |
5 |
1 - 5 |
||||
White staining |
Day2 – Day8 |
Day2 |
Day2 – Day8 |
Day2 – Day9 |
--- |
Day2 - Day8 |
Day2 - Day8 |
Day2 - Day8 |
Day2 - Day8 |
Day2 - Day8 |
Erythema (grade 1 - 4) |
--- |
--- |
Day2 – Day3 (grade1) |
--- |
Day2 (grade 1) |
--- |
--- |
--- |
--- |
--- |
Scales (grade 1 - 3) |
Day3 – Day12 (grade 1) |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
--- |
Day 1 refers to the day of test substance administration.
---: sign not observed
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
The acute toxicity of 2-Hexyl-2 ‘-hydroxy-5 ‘methyldecananilide (AF-654) was assessed in an oral toxicity study and a dermal toxicity study. No inhalation toxicity study is available.
In an acute oral toxicity study performed according to OECD Guideline 423, the limit dose of 2000 mg/kg bw AF-654 was administered by gavage to 3 female Wistar rats in a first step and to 3 male Wistar rats in a second step (Hooiveld, 2003a). Animals were observed daily for clinical signs and body weight was determined weekly. Macroscopic examination was performed at the end of the 14-day observation period at terminal sacrifice. There were no mortalities during the observation period and body weight gain of all animals was normal. Clinical signs were noted between Days 1 and 3 and included lethargy, hunched posture, uncoordinated movements and piloerection in all animals. Moreover, all males showed ptosis on Day 1. Those effects are known to be stress related and are therefore not considered to be due to test substance treatment. Additionally, no treatment-related abnormalities were found during the macroscopic post mortem examination of the animals. Based on the results of this study, the LD50 value was determined to be > 2000 mg/kg bw in rats. In accordance with OECD Guideline 423, Annex 2d, a cut-off value of 5000 mg/kg bw was derived, since no mortality occurred in any step at the limit dose of 2000 mg/kg bw.
The acute dermal toxicity of AF-654 was assessed in a limit test performed in 5 male and 5 female Wistar rats according to OECD Guideline 402 (van Otterdijk, 2004a). A single dose of 2000 mg/kg bw of the test substance in propylene glycol was applied to the clipped skin of rats under occlusive conditions for 24 hours. There was no mortality and no effects on body weight during the 14-day observation period. Flat/hunched posture and/or chromodacryorrhoea were noted among all animals between Days 1 and 5. The necropsy and gross pathological examination did not show any treatment-related effects. White staining of the treated skin area was noted among most animals between Days 2 and 9. In addition, general erythema (Days 2 and/or 3) or scales (between Days 3 and 12) were noted on the treated skin area of some females. The LD50 value for systemic toxicity is considered to be > 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
There is only one study available.
Justification for selection of acute toxicity – inhalation endpoint
No study required since the substance has a low potential for exposure via the inhalation route taking into account the physico-chemical properties and the conditions of use.
Justification for selection of acute toxicity – dermal endpoint
There is only one study available.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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.
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