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EC number: 235-546-0 | CAS number: 12270-13-2
- 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
The potential of the source substance (90% purity) to cause skin sensitisation reactions was assessed in a dermal sensitization study using the modified Buehler test (OECD 406). Based on the results obtained from this test, the source substance can be considered to be a non-sensitizer.
Furthermore, the substance was assessed in two Human Repeated Insult Patch Tests (Shelanski, 1971 and Shelanski, 1973, see IUCLID section 7.10.4) with 200 volunteers each. Both studies had negative outcome showing no visible skin changes in any subjects, except one volunteer having a severe reaction (Shelanski, 1973).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % in bi-distilled water
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- 2 animals with slight confluent erythema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % in bi-distilled water
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- 2 animals with slight patchy erythema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, based on the results obtained from a dermal skin sensitisation test, the test item can be considered to be a non-sensitizer.
- Executive summary:
In a dermal sensitization study with the test substance (90% purity) in bi-distilled water (50% w/w), young, male Himalayan guinea pigs (20 animals/test group & 10 animals/control) were tested using the modified Buehler test (OECD 406). Twenty male guinea pigs were treated topically with the test article 50% in bi-distilled water once a week for a three week induction phase. Two weeks after the final induction the animals were challenged with the same test substance used for induction at 50% in bi-distilled water. The animals of the control group were not treated during induction, but were treated once at challenge. Only two animals of the test group showed a slight confluent erythema at the first (24 h) and a slight, patchy erythema at the second reading (48 h). These findings were considered to be not significant. Therefore, based on the results obtained, the test item can be considered to be a non-sensitizer.
This information is used in a read-across approach in the assessment of the target substance.
For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
Reference
Table 1: Results of the induction screening
Irritancy results |
||||||||
|
24 hours reading Concentrations (%) of the test substance |
24 hours reading Concentrations (%) of the test substance |
||||||
Response grade (erythema) |
50 |
25 |
15 |
10 |
50 |
25 |
15 |
10 |
0 |
4* |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
± |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* = number of animals showing response
Grade 0 and ± are considered to be representative of insignificant response, whereas those of one or greater are considered to be significant. The results of the 24- and 48 hours reading were taken into consideration and in this case the test article at 50, 25, 15, and 10 % resulted in 4 scores of 0. Therefore the most representative concentration to stimulate a state of immune hypersensitivity is 50% in bi-distilled water.
Table 2 : Results of the challenge screening
|
24 hours reading Concentrations (%) of the test substance |
24 hours reading Concentrations (%) of the test substance |
||||||
Response grade (erythema) |
50 |
25 |
15 |
10 |
50 |
25 |
15 |
10 |
0 |
0* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
± |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* = number of animals showing response
The highest non-irritating concentration is determined as the concentration which induces responses in the four guinea pigs no more severe than two grades of +/-and two of 0. In this case, all concentrations resulted in 4 scores of 0. Therefore, the highest non-irritating concentration for the challenge was determined as the concentration of 50% in bi-distilled water
Table 3: Primary Sensitization Results (Incidence Tables)
Erythema score |
Test group 20 animals |
Control group 10 animals |
||
|
24 hrs |
48 hrs |
24 hrs |
48 hrs |
0 |
18 |
18 |
10 |
10 |
± |
0 |
2 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
No. with grades ≥ 1 |
2 |
0 |
0 |
0 |
No. Tested |
20 |
20 |
20 |
20 |
Total** |
2 |
0 |
** The Total is the number of animals showing a grade ≥ 1 at either 24 or 48 hours.
10% of the animals of the test group were observed with positive reactions (grade 0 and ± are considered to be non-significant responses, whereas those of 1 and greater are considered to be significant) after challenge performed with the highest non-irritating concentration of the test item at 50% in bi-distilled water. No reactions were observed in the control group treated in the same conditions during the challenge phase. Significant responses in at least 15 % of the test group is considered positive and would be warrant for classification. Therefore the test item tested as described, is considered to be a non-sensitizer.
Mortality:
As there were no deaths during the course of the treatment period no necropsies were performed.
Clinical Signs:
Neither local nor systemic symptoms were observed during the study.
Skin Effect in the Challenge:
Two animals of the test group were observed with defined erythema at the 24-hours reading when treated with the highest non-irritating test article concentration of 50% in bi-distilled water. The same reaction was seen at the 48-hour reading with less severity.
Body weight:
One out of 10 animals of the control group, four out of 20 animals of the test group and 3 out of 4 animals of the irritation screen for challenge lost weight during their acclimatization period. Three out of 4 animals of the irritation screen for induction lost weight during their treatment period. No loss of weight was observed during the treatment phase of the control -, test - and irritation screen for challenge group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data is available for the target substance. Thus, available data from a structural analogue (chloride salt) of the target substance was used in a read-across approach. Details on the read-across rational are provided in section 13.
In a dermal sensitization study with the source substance (90% purity) in bi-distilled water (50% w/w), young, male Himalayan guinea pigs (20 animals/test group & 10 animals/control) were tested using the modified Buehler test (OECD 406). Twenty male guinea pigs were treated topically with the test article 50% in bi-distilled water once a week for a three week induction phase. Two weeks after the final induction the animals were challenged with the same test substance used for induction at 50% in bi-distilled water. The animals of the control group were not treated during induction, but were treated once at challenge. Only two animals of the test group showed a slight confluent erythema at the first (24 h) and a slight, patchy erythema at the second reading (48 h). These findings were considered to be not significant. Therefore, based on the results obtained, the source substance can be considered to be a non-sensitizer.
Furthermore, the the source substance was assessed in two Human Repeated Insult Patch Tests (Shelanski, 1971 and Shelanski, 1973, see IUCLID section 7.10.4) with 200 volunteers each. Both studies had negative outcome showing no visible skin changes in any subjects, except one volunteer having a severe reaction (Shelanski, 1973).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a dermal sensitization study conducted according to OECD 406, male guinea pigs were tested negative for the source substance. Based on the results from the read-across partner, classification of the target substance is not warranted.
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