Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 925-462-9 | CAS number: 1182723-73-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across, GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guideline 429 was 1998 not yet available/adopted.
Test material
- Reference substance name:
- 116649-85-5
- Cas Number:
- 116649-85-5
- IUPAC Name:
- 116649-85-5
- Reference substance name:
- Bay u 3405
- IUPAC Name:
- Bay u 3405
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH Laboratory Animal Breeders, 33176 Borchen, Germany
- Age at study initiation: 3 - 5 weeks
- Diet: ad libitum
- Water: ad libitum
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Concentration / amount:
- Dose-finding study:
- intradermal injection with 0, 1, 2.5, and 5% (at 1% grey injection site after 24 hours and red wheal after 48 hours)
- topical application with 0, 6, 12, and 25%
- challenge with 0, 6, 12, 25%
Based on the results the following concentrations for the main study were selected:
- intradermal injection for induction: 1% (= 4 mg test item/animal)
- topical application for induction and challenge: 25% (= 125 mg test item/animal)
From preliminary investigations 25% in PEG 400 were visually described as suspension.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Concentration / amount:
- Dose-finding study:
- intradermal injection with 0, 1, 2.5, and 5% (at 1% grey injection site after 24 hours and red wheal after 48 hours)
- topical application with 0, 6, 12, and 25%
- challenge with 0, 6, 12, 25%
Based on the results the following concentrations for the main study were selected:
- intradermal injection for induction: 1% (= 4 mg test item/animal)
- topical application for induction and challenge: 25% (= 125 mg test item/animal)
From preliminary investigations 25% in PEG 400 were visually described as suspension.
- No. of animals per dose:
- 10 animals in test group, 5 animals in control group
- Positive control substance(s):
- yes
- Remarks:
- the sensitivity of the test is checked periodically with 2-mercaptobenzothiazole
Study design: in vivo (LLNA)
- Vehicle:
- other: PBS buffer
- Concentration:
- 0, 1, 10, 50 %
- No. of animals per dose:
- 6
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
The test item in the formulation or the vehicle were applied epicutaneously onto the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days (d0, d1 and d2). The volume administered was 25µl/ear. The used concentrations were based on the experiences with the test system and the toxic properties of the test substance.
The animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after the last application (d3). The appropriate organs were then removed. Lymphatic organs (the auricular lymph nodes) were transferred into physiological saline (PBS).
Investigations:
- weight of draining lymph nodes (given as weight index compared to vehicle controls)
- cell counts in draining lymph nodes (given as cell count index compared to vehicle controls)
Stimulation indices were calculated by dividing the absolute weight or number of cell counts of the substance treated lymph nodes by the vehicle treated ones.
- ear swelling (given in 0.01 mm and as index)
- ear weight (given in mg/8 mm diameter punch and as index) - Positive control substance(s):
- not specified
- Statistics:
- When it was statistically reasonable, the values from treated groups were compared with those from the control group by the Mann-Whitney or the Wilcoxon signigicance test (U-test) at significance levels of 5 and 1% (one-tailed for LLNA/IMDS or PNLA (larger)). Outlying values in the LN/ear weights or LN cell counts were eliminated at a probability level of 99% by Nalimov's method. In addition, for the LLNA/IMDS the smallest significant differentes in the means were calculated by Scheffels method, which according to Sachs can be used for both equal and unequal sample sizes.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 1st and 2nd reading
- Group:
- test chemical
- Dose level:
- 1% for intradermal induction, 25% for topical induction, 25% for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 1st and 2nd reading. Group: test group. Dose level: 1% for intradermal induction, 25% for topical induction, 25% for challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: 1st and 2nd reading
- Group:
- negative control
- Dose level:
- 25% for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 1st and 2nd reading. Group: negative control. Dose level: 25% for challenge. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- No significant dose-dependent increase in the stimulation indices for the weight or cell counts in the lymph nodes as well as for ear swelling or ear weights was seen and statistical analysis revealed no significant effect for the test item ethoxyamidin. However, the cell count index of the mid dose group exceeded the 'positive level' which is 1.25.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
- Bay u 3405 HS was investigated for skin sensitization in the Guinea Pig Maximization Test according to OECD TG 406. Ten Guinea pigs were dosed for intradermal induction (1%), topical induction (25%) and for topical challenge (25%) in PEG 400. The results show that the test item has no skin sensitizing potential in Guinea pigs under the conditions of this test.
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.