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Registration Dossier
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Diss Factsheets
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EC number: 701-135-4 | 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:
- Study report dated 28 September 1976 (no additional details)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- prior to GLP
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- "This particular study (non-LLNA method test) was conducted in 1976, before the ECHA recommendation of conducting LLNA to fulfil the study requirement came into effect. Hence in order to avoid additional animal testing, this study has been used as key study for the dossier".
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The animals, weighing between 400 to 450 grams, were housed individually in Macrolon cages, kept at a constant room temperature of 22 +/- 1° C, at a relative humidity of 55% +/- 5 % and on a 14 hours light cycle day. The animals received ad libitum standard guinea pig pellets (NAFAG, No. 830, Gossau SG) and water.
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % dilution in saline
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 % dilution in saline
- No. of animals per dose:
- 20
- Details on study design:
- During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a
freshly prepared 0.1 % dilution in saline. One control group was treated with the vehicle alone (negative control). On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
During the second and third week of the induction period the test materials were incorporated in a mixture (1:1) of the normal vehicle with 'complete Bacto Adjuvant.
Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % dilution of the test material in saline was administered into the skin of the left flank.
Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were
recorded. Before examination, the reaction sites were depilated chemically (Butoquick®, 5 minutes) The two largest perpendicular diameters (in mm)
and the increase in the skin-fold thickness (in mm) were measured, and by multiplication of these values "reaction volume" was obtained (in ul) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the "skin irritation threshold" for each animal. Any challenge reaction greater than this threshold value in the challenge period was graded as an allergic reaction and the animal termed "positive".
The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude (negative control). - Challenge controls:
- One control group was treated with the vehicle alone (negative control) and a positive control group was treated with DNCB.
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Positive control results:
- 20/20 animals showed a positve response to DNCB (Dinitrochlorobenzene)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- irritation during induction was noted in 5 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: irritation during induction was noted in 5 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: criteria of assay
- Conclusions:
- According to the study report, the test material is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.
- Executive summary:
The optimization test, an intracutaneous sensitization procedure, was performed on groups of 10 male and 10 female guinea pigs. Induction doses were administered by intradermal injection with adjuvant incorporated 1:1 in vehilcle during weeks 2 and 3 of induction.
Fourteen days after the last induction injection, challenge was performed by injection.
Twenty-four hours after each injection during the first week of the induction period the reactions were recorded and skin thickness measured. Skin thickness was taken as representing the skin irritation "threshold" for each animal. Twenty-four hours the challenge injection the reactions were recorded.
Intradermal injection of the vehicle alone failed to induce a skin response before or after skin sensitization.
The incidence of positive reactors for the groups treated with DNCB was 20 of 20. The incidence of positive reactors for the groups treated with the test material was 5 of 20. According to the criteria of the Optimization test, the test material is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Migrated from Short description of key information:
20/20 guinea pigs showed no indication of sensitization in the Optimization test however, this study was conducted in 1976 and prior to GLP guidance and therefore based on structurale analogy of this substance with other epoxy substances, a precautionary/conservative classification as Skin sensitsation Cat 1B is recommended
Justification for selection of skin sensitisation endpoint:
20/20 guinea pigs showed no indication of sensitization in the Optimization test however, this study was conducted in 1976 and prior to GLP guidance and therefore based on structurale analogy of this substance with other epoxy substances, a precautionary/conservative classification as Skin
sensitsation Cat 1B is recommended
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
20/20 guinea pigs showed no indication of sensitization in the optimization test however, this study was conducted in 1976 and prior to GLP guidance and therefore based on structural analogy of this substance with other epoxy substances, a precautionary/conservative classification as Skin sensitsation Cat 1B is recommended.
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