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EC number: 618-311-0 | CAS number: 898543-06-1
- 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
Skin Sensitisation, Maximization Test according to Magnusson and Kligman (Guinea pig, GLP, OECD TG 406, EU-Method B.6, OPPTS 870.2600): sensitising
[Bayer AG, Report No. PH-34678, 2006-11-23]
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:
- Sep to Oct 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- for global regulatory acceptance of this pharmaceutical intermediate an GPMT was required
- Specific details on test material used for the study:
- Batch BXR36DP
purity: 98.9% - Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Cremophor EL/sterile physiological saline solution 2% v/v
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test substance/animal)
Topical induction: 50% (= 250 mg test substance/animal) - Day(s)/duration:
- 2d
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Cremophor EL/sterile physiological saline solution 2% v/v
- Concentration / amount:
- 50% (= 250 mg test substance/animal)
- Day(s)/duration:
- 1d
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- control group. 10
test substance group: 20
range-finding group: 2 - Details on study design:
- Intradermal Induction: The dorsal region and the flanks of the guinea pigs were shorn one day prior to the application. Starting behind the nape of the neck, three injections each in a row were made on the left and the right side of the spinal column. The 1st and 2nd injections were made as contiguous as possible and the 3rd injections in a distance of about 2 cm from the 2nd. The volume applied per injection site was 0.1 ml.
The topical induction was performed one week after the intradermal induction. On the day prior to topical treatment, the test areas of the animals were shorn. Hypoallergenic patches (2x4 cm) were placed between and on the injection sites, covered with aluminum foil and held securely in place on the skin using a ORABAND® self-adhesive tape (Fa. Orafol). At the end of the 48-hour exposure period, the remaining test item was removed with sterile physicological saline solution and the treatment areas were visually assessed.
The challenge was performed three weeks after the intradermal induction. In the meantime, the test item concentrations for the challenge had been determined in a dose range-finding study using 2 guinea pigs that were treated during the inductions in the same manner as the control animals (see page 26). The dorsal region and the right flank of the animals were shorn one day prior to the challenge. During the challenge a hypoallergenic patch loaded with the 0.5% test item formulation was placed on the right flank (caudal) of the animals of the test item group and the control group and held securely in place on the skin with a ORABAND® self-adhesive tape for 24 hours. A patch loaded only with the vehicle was placed also on the right flank (cranial) as control. The volume applied in each case was 0.5 ml. At the end of the exposure period, the remaining test item was removed with physiological saline solution, and 21 hours later the skin of the animals was shorn in the zone of the challenge area. - Positive control substance(s):
- no
- Remarks:
- alpha-Hexylzimtaldehyd used in a separate test for reliability of the method
- Positive control results:
- Reliability of the Method (Report PH-34587):
The Guinea Pig Maximization Test methodology was checked for reliability in a test on female guinea pigs using alpha-Hexylzimtaldehyd formulated in sterile physicological saline solution at the concentrations indicated below:
For the intradermal induction a 5% test item formulation was used, and for the topical induction a 25% formulation. After the challenge with a 12% test item formulation 100% of the test animals exhibited dermal reactions in the challenge treatment. There was no reddening of the skin to be observed on control group animals. The sensitivity as well as the reliability of the experimental technique is thus confirmed by this study. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- skin reactions grade 1-3
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 12%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- skin reactions grade 1-3
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- skin reactions grade 1-2
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- skin reactions grade 1-2
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- skin-sensitization potential; hazard class H317 ; 100% of animals reacted positively after challenge with grade 1-2
- Executive summary:
In a Guinea Pig Maximization Test (S)-Oxamin HCL was examined in female guinea pigs for its skin sensitizing properties. The intradermal induction was performed using a 5% test item concentration, and the topical induction was performed with a 50% test item concentration.
The test item was formulated in Cremophor EL/sterile physiological saline solution 2% v/v to yield a solution (5%-12%) or a suspension (25%-50%).
After the intradermal induction the animals in the control group and in the test item group showed strong effects up to encrustation at the injection sites of the first induction.
The challenge with the 50% test item concentration led to skin effects (grade 1-2) in 20 of 20 animals of the test item group (100%) and to no skin effects in the animals of the control group.
In summary, by comparing the results in the treatment group and in the control group under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits a skin-sensitization potential.
Reference
Appearance and behaviour of the test substance group were not different from the control groups. At the end of the study, the mean body weight of the treatment group animals was in the same range than that of the control group animals.
After the intradermal induction the animals in the control group and the test item group showed strong effects up to encrustation at the injection sites of the first induction.
The incidence of skin reactions (number of animals exhibiting skin effects) following the challenge is summarized in the following table:
Test substance group (20 animals) | Control group (10 animals) | |||||||||
Test substance patch | Control patch | Test substance patch | Control patch | |||||||
Hours | 48 | 72 | total | 48 | 72 | 48 | 72 | total | 48 | 72 |
Challenge 50% | 20 | 20 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The observed skin effects were grade 1 -2.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The Guinea Pig Maximization Test was performed on female guinea pigs according to OECD guideline 406 to determine wether the (S)-Oxamin Hydrochlorid exhibits skin-sensitizing properties. The study was conducted with the following test item concentrations:
intradermal induction: 5%
topical induction: 50%
challenge: 50%
The challenge led to skin effects (grade 1 -2) in all animals of the test item group and therefore, under the condition of the maximization test and with respect to the evaluation criteria (S)-Oxamin-Hydrochlorid exhibits a skin-sensitization potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the study results (S)-Oxamin Hydrochlorid has to be classified as Skin Sens. Cat. 1B (H317) according to Regulation (EC) No. 1272/2008 (CLP).
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