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EC number: 462-560-6 | CAS number: 832088-68-3
- 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:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP, Guideline study. The study report pointed up two deviations from study plan but they were judged as minor deviations ((i) the name of the study director and (ii) the number of the test item because of a typing error) that do not affected the reliability of the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Albino Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Body Weight: between 286.4 g an d 341.1 g at the start of the experiment.
Age: between 3 an d 6 weeks at the start of the experiment.
Number: (i) preliminary study: 6 males, (ii) main study: treated group of 10 males and a negative control group of 5 males and (iii) positive control group (at least every 6 months): 5 males. [The study involved 6 males far a preliminary test, and 15 males for the main study].
Allocation to treatment to each animal was randomly determined before the start of the study on the day prior to the first day of administration (D-1 ). Homogeneity of groups was validated on the criterion of body weight measured on the day of randomization. In each group, individual weights of the animals did not deviate from the group mean weight by more than ± 20%.
Housing: five males from each treatment group were kept in a cage of standard size, on dust-free white wood shavings (or equivalent) as bedding. The cages were cleaned according to the CERB SOP. The animals were placed in an air-conditioned (20 °C ± 3 °C) animal house kept at relative humidity between 45% and 65% (except during the cleaning slot) in which non-recycled filtered air which was changed approximately 10 times per hour. The artificial day/night cycle involved 12 hours light and 12 hours darkness (lights on at 7.30 a.m.).
Feeding: FD1 (P) SQC SDS/DIETEX feed distributed daily at fixed times. The criteria for acceptable levels of contaminants in the feed supplied were within the limits of the analytical specifications established by the diet manufacturer.
Drinking water: drinking water with 0.02% vitamin C added was available ad libitum in polycarbonate feeder bottles with a stainless steel nipple. A specimen of water is obtained every 6 months and sent to the another laboratory for analysis. The criteria far acceptable levels of contaminants in the water supplied were within the limits of the analytical specifications.
Vehicle: sterile water was chosen an the basis of the physico-chemical characteristics of the test item.
Only healthy animals with an intact skin were used for the experiment. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sterile water
- Concentration / amount:
- Solid test item was tested in emulsion.
Concentrations were expressed as percentage weight of test item/weight of preparatian (w/w):
25% (w/w)
10% (w/w)
2.5% (w/w)
1% (w/w)
0.5% (w/w)
0.25% (w/w)
0.1% (w/w)
0.05% (w/w) were tested. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sterile water
- Concentration / amount:
- Solid test item was tested in emulsion.
Concentrations were expressed as percentage weight of test item/weight of preparatian (w/w):
25% (w/w)
10% (w/w)
2.5% (w/w)
1% (w/w)
0.5% (w/w)
0.25% (w/w)
0.1% (w/w)
0.05% (w/w) were tested. - No. of animals per dose:
- 2
- Details on study design:
- The test involved three subsequent treatments:
- intradermal induction: first contact between the body and FEX0-07
- topical induction: second contact with FEX0-07; in case of sensitising item recognition of allergen with multiplication of cellular and/or humoral transformation processes
- topical challenge: third contact with FEX0-07 (an area of skin having never previously been in contact with FEX0-07) leading to the occurrence of a cutaneous clinical manifestation if FEX0-07 has a sensitising potential. - Challenge controls:
- A negative control group of 5 males has been chosen. (The control group was used to confirm that under the experimental conditions adopted, the appearance of skin reactions in the treated group in the absence of any reaction in the controls was due to an allergic response and not to skin irritation).
- Positive control substance(s):
- yes
- Remarks:
- Positive control group (at least every 6 months): 5 males.
- Positive control results:
- In the positive control group in which animals were treated with HCA solution, 100% of animals showed skin reaction (score 1 to 2) at 24 and 48 hours.
(The positive test item HCA appeared as an extreme sensitiser). - Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions adopted, the test item FEX0-07 is free of any sensitising capacity in the male guinea pig.
- Executive summary:
The possible de1ayed sensitising capacity of FEX0-07 was evaluated in the male guinea pig in accordance with the General Requirements of OECD Guideline N. 406 and the method B6 of Commission Directive N. 96/54/EC. The experimental technique is based on these of Magnusson, Kligman, Guillot and Coll.
The application of the test item FEX0-07 did not induce colouring of the application site.
Determination of the degree of allergenicity at times 24 and 48 hours was based upon the percentage of animals in the group showing a reaction, rather than on the severity of the latter. Under the experimental conditions adopted, results obtained were as fol1ows: No irritation reaction was noted at times 24 and 48 hours in animals of the negative control group and in animals treated during the challenge phase with the test item FEX0-07 at the Maximum Nonirritant Concentration (MNJC).
Under the experimental conditions adopted, the test item FEX0-07 is considered free of any sensitising capacity in the male guinea pig.
Reference
Intradermal injections
- 2.5% (w/w) and l% (w/w) of FEX0 -07 in sterile water, any animal presented a discrete or patchy erythema (score l)
- 0.5% (w/w), 0.25% (w/w), 0.1% (w/w) and 0.05% (w/w) of FEX0-07 in sterile water, no skin reaction was observed in any animal - 2.5% (w/w) FEX0-07 diluted in sterile water, the injections were so difficult and the concentration was not also chosen for the main study.
Cutaneous application
First topical application: at 25% (w/w) and 10% (w/w) of FEX0-07 in sterile water, no skin reaction was noted in any animal.
Second topical application: at 25% (w/w) and 10% (w/w) of FEX0-07 in sterile water, no skin reaction was noted in any animal.
In conclusion:
- the maximum injectable concentration causing a moderate irritation tested by intradermal administration was 1% (w/w) of
FEX0-07 diluted in sterile water (it was used during the primary induction phase on D1)
- the maximum concentration causing a moderate irritation tested by cutaneous application was 25% (w/w) of FEX0-07 (it was used during the second induction phase or sensitisation phase on D9).
- the maximum non-irritant concentration (MNIC) determined by cutaneous application was 25% (w/w) of FEX0-07 diluted in sterile water (it was used in the challcnge phase on D22).
The following tables document the results that were judged more representative for this test report:
Table 2.5. Skin lesions - Individual scores - FEXO-07
Observations (range of scores; normal score) | Time |
Animal serial number | |||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||
Skin lesions(0 -3; 0) | day 24 (24 h) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
day 25 (48 h) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2.7. Main study: Summary of results of cutaneous reactions: negative control and treated group.
Treatment | Time | N. of animals score 0 | N. of animals score 1 | N. of animals score 2 | N. of animals score 3 | % of sensitised animals |
Negative control | 24 h | 5 | 0 | 0 | 0 | 0 |
Negative control | 48 h | 5 | 0 | 0 | 0 | 0 |
FEXO-07 | 24 h | 10 | 0 | 0 | 0 | 0 |
FEXO-07 | 48 H | 10 | 0 | 0 | 0 | 0 |
Table 2.8. Main study: summary of results of cutaneous reactions: positive control.
Treatment | Time | N. of animals score 0 | N. of animals score 1 | N. of animals score 2 | N. of animals score 3 | % of sensitised animals |
Positive control | 24 h | 0 | 0 | 5 | 0 | 100 |
48 h | 0 | 1 | 4 | 0 | 100 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One key study (Klimisch score=1) was identified, in which FEXO-07 were tested for skin sensitisation in guinea pig using a method according to OECD 406 and EU method B.6.
A main study with a treated group of l0 males and a negative control group of 5 males was anticipated by a preliminary study with 6 animals.
The solid test item was tested in emulsion. Concentrations were expressed as percentage weight of test item/weight of preparation (w/w): 25%, 10%, 2.5%, l%, 0.5%, 0.25%, 0.1% and 0.05% were tested.
Determination of the degree of allergenicity at times 24 an d 48 hours was based upon the percentage of animals in the group showing a reaction, rather than on the severity of the latter.
Under the experimental conditions adopted, results obtained were as fol1ows: no irritation reaction was noted at times 24 and 48 hours in animals of the negative control group and in animals treated during the challenge phase with the test item at the Maximum Non Irritant Concentration.
Migrated from Short description of key information:
One key skin sensitisation study (OECD 406 and EU method B.6) was identified.
FEXO-07 tested was found free of any sensitising capacity in the male guinea pig.
Justification for selection of skin sensitisation endpoint:
Only one end-point was available for the selection. However, it was judged as reliable because the test was performed in accordance with validated guidelines
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on evaluation of the skin sensitisation data discussed above, FEXO-07 was found to be non-sensitisating for the skin of the guinea pig so it does not meet the criteria for classification and labelling under both the CLP Regulation and the Directive 67/548/EEC.
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