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EC number: 939-727-1 | 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
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:
- 19 August – 12 September 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study conducted in compliance with OECD Guideline 406 with minor deviation: age of the animals not reported; no data on the housing conditions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- age of the animals not reported; no data on the housing conditions
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- COFRAC Accreditation for technical ability
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the OECD guideline 429 was adopted.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER (Saint Aubin Les Elbeuf, France)
- Weight at study initiation: 333-392 g
- Housing: Individually in polypropylene cage
- Diet: Pelleted diet UAR 106 (Epinay sur Orge, France)
- Acclimation period: At least 5 days - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Range finding tests:
- Determination of maximum non-irritating concentration: 12.5, 25, 50 and 100 % (w/v) in distilled water
- Determination of maximum irritating concentration: 12.5, 25, 50 and 100 % (w/v)
Main test:
- Intradermal induction exposure: 12.5 % (w/v) in distilled water, 12.5 % (w/v) in a mixture of 1:1 (v/v) of Freund's Complete Adjuvant (FCA) and distilled water
- Topical induction exposure: Undiluted
- Topical challenge exposure: 12.5 and 25 % (w/v) in distilled water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Range finding tests:
- Determination of maximum non-irritating concentration: 12.5, 25, 50 and 100 % (w/v) in distilled water
- Determination of maximum irritating concentration: 12.5, 25, 50 and 100 % (w/v)
Main test:
- Intradermal induction exposure: 12.5 % (w/v) in distilled water, 12.5 % (w/v) in a mixture of 1:1 (v/v) of Freund's Complete Adjuvant (FCA) and distilled water
- Topical induction exposure: Undiluted
- Topical challenge exposure: 12.5 and 25 % (w/v) in distilled water - No. of animals per dose:
- - Range finding test: 2 or 3 animals
- Main test: 5 and 10 animals for control and treatment group, respectively - Details on study design:
- RANGE FINDING TEST:
- Determination of maximum non-irritating concentration: Three guinea pigs were intradermally injected with 3 injections (0.1 mL each) of distilled water, a mixture of 1:1 (v/v) of FCA and distilled water, and distilled water diluted to 50 % in a mixture of 1:1 (v/v) of FCA and distilled water. After 7 days, the animals applied topically with 0.2 mL of 12.5, 25, 50 and 100 % w/v of test material in distilled water via occlusive patch for 24 h and evaluated for cutaneous irritation reactions at 24 and 48 h after removal of patches.
- Determination of maximum irritating concentration by intradermal injections: Two guinea pigs were intradermally injected with 4 injections (0.1 mL each) of test material at concentrations of 12.5, 25, 50 and 100 % (w/v).
MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: One
- Day of induction: Day 1
- Test group: Intradermally injected with 3 injections (0.1 mL each) of a mixture of 1:1 (v/v) of FCA and distilled water, test material diluted to 12.5 % in distilled water, test material diluted to 12.5 % in a mixture of 1:1 (v/v) of FCA and distilled water, on Day 1
- Control group: Intradermally injected with 3 injections (0.1 mL each) of distilled water, a mixture of 1:1 (v/v) of FCA and distilled water and 50 % of distilled water in a mixture of 1:1 (v/v) of FCA and distilled water, on Day 1
- Site: Both sides of the spinal column, at the shoulder level
B. INDUCTION EXPOSURE: TOPICAL
- No. of exposures: One
- Day of induction: Day 9
- Exposure period: 48 h
- Test group: Filter paper patch (2 x 4 cm) saturated with 0.5 mL of the undiluted test material applied topically via occlusive patch
- Control group: Filter paper patch (2 x 4 cm) saturated with 0.5 mL of distilled water applied topically via occlusive patch
- Site: Same intradermally injected area
- Frequency of applications: Single application
C. CHALLENGE EXPOSURE: TOPICAL
- No. of exposures: One
- Day of challenge: Day 23
- Exposure period: 24 h
- Test and control groups: Filter paper (2 x 2 cm) patch saturated with 0.2 mL of the test material diluted to 12.5 and 25 % in distilled water topically applied to the dorso-lumbar region of each animal via occlusive patch.
- Evaluation (h after removal of challenge patch): 24 and 48 h
OTHER:
- Body weight: Animals were weighed individually on Days 1 and 25 of the study. - Challenge controls:
- Filter paper (2 x 2 cm) patch saturated with 0.2 mL of the test material diluted to 12.5 and 25 % in distilled water topically applied to the dorso-lumbar region of each animal via occlusive patch.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercapto Benzothiazole; 5 and 2 % in vaseline
- Positive control results:
- In the study EVIC-CEBA Td 044 of 21 February 1997, 2-Mercapto Benzothiazole (positive control) was found to be moderately sensitising for the guinea-pig (60 % of reactive animals) when it was used diluted to 5 and 2 % in vaseline.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5 and 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5 and 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12.5 and 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5 and 25 % (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 5 and 2 % (w/v)
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these test conditions, CHIMEXANE NB - LOT M 824 is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008)
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406, 10 female Hartley guinea pigs were induced with intradermal injections (0.1 mL each) of a mixture of 1:1 (v/v) of FCA and distilled water, 12.5 % (w/v) CHIMEXANE NB - LOT M 824 in distilled water, and 12.5 % (w/v) CHIMEXANE NB - LOT M 824 in a mixture of 1:1 (v/v) of FCA and distilled water, on Day 1 on three different sites on each side of the spinal column at the shoulder level. Control group of 5 females were intradermally induced with 0.1 mL of FCA plus distilled water (1:1), distilled water and FCA plus distilled water (1:1). After 7 days, the same area was topically induced with undiluted test material via occluded filter paper patch for 48 h for the treated group. Control group was patched with filter paper saturated with distilled water. After 11 days of rest period, challenge filter paper patches of 12.5 and 25 % w/v of test material in distilled water were applied to the dorso-lumbar region of each animal via occlusive patch. The test concentrations for the main study were determined from a range-finding study using two or three animals per exposure.
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. CHIMEXANE NB - LOT M 824 produced a 0 % (0/10) sensitisation rate and was considered to be a non-sensitiser to guinea pig skin. Positive control (2-Mercapto Benzothiazole; 5 and 2 % in vaseline) exhibited evidence of sensitisation.
Under these test conditions, CHIMEXANE NB - LOT M 824 is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008).
Reference
- Bodyweight gains of guinea pigs in the test group were comparable to those observed in the control group animals.
- General state of health of all guinea-pigs put in experimentation remained satisfactory throughout the test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406, 10 female Hartley guinea pigs were induced with intradermal injections of a mixture of 1:1 (v/v) of FCA and distilled water, 12.5 % (w/v) CHIMEXANE NB in distilled water, and 12.5 % (w/v) CHIMEXANE NB in a mixture of 1:1 (v/v) of FCA and distilled water and 7 days later by topical application of CHIMEXANE NB undiluted. They were then challenged at 12.5 and 25%.
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 h observations. CHIMEXANE NB was considered to be a non-sensitiser to guinea pig skin.
Migrated from Short description of key information:
In a skin sensitisation study conducted according to OECD guideline 406, CHIMEXANE NB (CAS No 71032-90-1) was not a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
Only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Under the test conditions, CHIMEXANE NB is not classified as skin sensitiser according to the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008).
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