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EC number: 605-399-0 | CAS number: 165252-70-0
- 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
Based on a skin reaction incidence of 0 % according to the CLP regulation, dinotefuran is not a dermal sensitiser in the guinea pig, and no EU classification is required .
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
- Study period:
- 08/01/1997 - 09/12/1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- (1982)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan no. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted in 1997, which is prior to adoption in 2002 of the LLNA OECD TG 420. The study is submitted in the context of this REACH dossier as it provides key information non the non-sensitising classification of dinotefuran and remains adequate; this study was generated for product registration purposes in other countries.
- Species:
- guinea pig
- Strain:
- other: Crl:[HA]BR
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 - 8 weeks old
- Weight at study initiation: 372 - 500 g - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Carboxyl Methyl Cellulose (CMC)/distilled water and Freund's Complete Adjuvant (FCA) for the intradermal injection phase and as a mixture in petrolatum for the topical induction application and challenge phase of the definitive study.
- Concentration / amount:
- 1 % v/w, 5 % v/w, 10 % v/w, 15 % v/w
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Carboxyl Methyl Cellulose (CMC)/distilled water and Freund's Complete Adjuvant (FCA) for the intradermal injection phase and as a mixture in petrolatum for the topical induction application and challenge phase of the definitive study.
- Concentration / amount:
- 1 % v/w, 5 % v/w, 10 % v/w, 15 % v/w
- No. of animals per dose:
- 20 test animals (dinotefuran): exposed to the test substance at inductions and challenge.
- Details on study design:
- PRELIMINARY STUDY:
- A preliminary irritation study in which 2 groups of 4 guinea pigs were exposed by occluded topical application for 24 hours to dinotefuran at concentrations of 5, 10, 15 and 25% w/w in petrolatum, or intradermally at concentrations of 1, 5, 10 and 15% in aqueous carboxymethylcellulose. Dermal reactions were evaluated 24 and 48 hours after treatment.
MAIN STUDY
A. INDUCTION EXPOSURE
- Concentration of test substance: 5% w/v
- Induction vehicle: 0.5% CMC/distilled water and FCA for the intradermal injection phase and as a 25% (w/w) mixture in petrolatum for the topical induction application and challenge phase of the definitive study.
- No. of doses administered: On day 1, the test group received 3 pairs of intradermal injections of 50% FCA in water, 5% w/v dinotefuran in aqueous carboxymethylcellulose and 10% w/v dinotefuran in aqueous carboxymethylcellulose diluted 1:1 with FCA (i.e 5% dinotefuran with FCA). The control group received similar injections but without dinotefuran. On day 7, the application sites of both groups of animals were treated topically with 10% sodium lauryl sulfate which was massaged into the skin. On day 8, the animals were treated topically, over the injection sites, under occlusive dressing for 48 hours with 25% w/w dinotefuran in petrolatum (treated group) or petrolatum alone (irritation control group).
B. CHALLENGE EXPOSURE
- No. of exposures: Two weeks after day 8, both groups were challenged topically, under occlusive dressing for 24 hours, with 25% w/w dinotefuran in petrolatum (right side) and petrolatum alone (left side). The challenge sites were shaved and then scored for dermal reactions 24 and 48 hours after removal of the challenge dressings.
The substance was removed 24 hours after challenge.
GRADING SYSTEM USED: Performed according to the method of Magnusson & Kligman (Magnusson, B. and Kligman, A. (1970): Allergic Contact Dermatits in the Guinea Pig, Charles C. Thomas, pp. 113-117, 120).
No statistical analyses were employed. - Challenge controls:
- 20 irritation control animals (for dinotefuran): exposed to the test substance only at challenge.
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
- Positive control results:
- The positive control study was conducted within six months of the conduct of this study. The positive reaction of the challenge skin of all 10 positive control (hexylcinnamaldehyde) animals was observed, whereas all scores in the negative control group were zero. Therefore, hexylcinnamaldehyde was considered to be an extreme dermal sensitizer.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 1 animal exhibited thin appearance on days 1-19, hypoactivity and nonformed faeces on days 1-20 and 22-28. None after challenge
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 1 animal exhibited thin appearance on days 1-19, hypoactivity and nonformed faeces on days 1-20 and 22-28. None after challenge
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% w/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 1 animal exhibited nonformed stool on day 14 and 15 after challenge
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% w/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 1 animal exhibited nonformed stool on day 14 and 15 after challenge
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Based on a skin reaction incidence of 0 %, which is below the 30 % threshold of significance specified in Commission Directive 93/21/EEC, dinotefuran is not a dermal sensitiser in the guinea pig, and no EU classification is required (category IV according to EPA classification criteria and not classified according to GHS criteria). Dinotefuran does not induce skin sensitisation at concentrations ≤ 25%.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Preliminary study:
No dermal irritation occurred at any concentration of dinotefuran administered by topical application, up to 25% w/v. Therefore, all dermal reactions were scored as zero. In the 4 animals treated by intradermal injection, dinotefuran produced mild erythema (grade 1) at 1% w/v, mild-moderate diffuse erythema (grade 1 - 2) reactions at 5% w/v and moderate-marked erythema (grade 2 - 3) at 10 and 15% w/v (Table 7.4.1).
Main study:
There were no treatment-related clinical signs or adverse effects on body weight with the exception of one animal in the test group that appeared thin from day 20.
None of the test and control group animals exhibited a dermal response to the challenge application of the test or control articles either 24 or 48 hours after patch removal. Therefore, all dermal reaction scores were zero.
Table 7.4.1: Individual dermal reaction scores in the irritation screening study - intradermal injection
Animal |
Dermal reaction score at: |
|||||||
number |
1% w/v |
5% w/v |
10% w/v |
15% w/v |
||||
|
24hr |
48hr |
24hr |
48hr |
24hr |
48hr |
24hr |
48hr |
1 |
1 |
1 |
2 |
2 |
3 |
3 |
3 |
3 |
2 |
1 |
1 |
2 |
2 |
2 |
2 |
3 |
3 |
3 |
1 |
1 |
1 |
1 |
2 |
2 |
2 |
2 |
4 |
1 |
1 |
1 |
1 |
2 |
2 |
3 |
3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
For dinotefuran, oral LD50 values of 2804, 2000 and 2450 mg/kg are identified in rats for
males, females and for the sexes combined, respectively. Similar values were identified in
mice. In oral gavage rabbit developmental toxicity studies, clinical signs of toxicity were
observed on the first day of dosing at 300 mg/kg and above; the NOAEL for acute effects in
NZW rabbits is 125 mg/kg. The rat dermal LD50 value is estimated to be >2000 mg/kg and the
4 h inhalation LC50 value is estimated be > 4.09 mg/L in males and females. These data do
not support classification of dinotefuran for acute toxicity. Dinotefuran is not a skin, eye or
respiratory tract irritant nor a skin sensitiser.
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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