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EC number: 308-067-0 | CAS number: 97862-23-2
- 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
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. Based on the summarized studies,it can be concluded that the testchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on 3 skin sensitization studies as- WoE-2, WoE-3 and WoE-4.
Skin sensitization potential of test chemical was determined by tests on guinea pigs and humans. - GLP compliance:
- not specified
- Type of study:
- other: 1,2.a modified Buehler and Klecak method 3.patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: 1,2.guinea pig 3.Human
- Strain:
- other: 1,2.Albino 3. Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- other: 1,2.epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10% (0.1mL)
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- Route:
- other: 3.epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: 1,2.epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10.0%, 5.0%, and 2.50%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: 3.epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2%
- Day(s)/duration:
- 7 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1,2.10
3. 27 patients - Details on study design:
- 1,2.MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hour
- Test groups: 10
- Control group: no data
- Site: shaved left flanks of ten albino guinea pigs over a 1.8-cm circular area.
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two week rest period
- Exposure period: 24 hours
- Test groups: 10
- Control group:
- Site: shaved left flanks of ten albino guinea pigs
- Concentrations: 10.0%, 5.0%, and 2.50%
- Evaluation (hr after challenge): 24 hour and 48 hours
3. The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.The reactions of the patients were graded as ?+. + and ++ categories. - Positive control substance(s):
- yes
- Remarks:
- 1,2.0.5% DNCB 3.Not specified
- Positive control results:
- 1,2.The positive DNCB (2, 4-dinitrochlorobenze) control at the 0.5% induction /challenge concentration elicited positive response in all animals tested.
- Reading:
- other: 1,2.1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10.0%, 5.0%, and 2.50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema/edema was observed after 24 and 48 hours post-application.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3. 1st reading
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Clinical observations:
- None of the treated patients showed allergic contact dermatitis.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical was considered to be skin sensitizing to the skin of guinea pigs and humans.
- Executive summary:
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:
Skin sensitization studies for two structurally similar read across chemicals were conducted in guinea pig using modified Buehler and Klecak method for open epicutaneous testing. In each study, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the test material was applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase. No erythema/edema was observed after 24 and 48 hours post-application. Hence the test substances were considered as not sensitizing to the guinea pigs skin.
The above results were further supported by the patch test study performed on another similar read across chemical to determine the allergic contact dermatitis caused by the chemical on human patients. The dye was applied on27patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.None of the treated patients showedany signs ofallergic contact dermatitis. Hencethe test chemical can be considered as non-sensitizer to human skin.
Based on the above summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Reference
1,2.
All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale
0 = no reaction,
1 = slight reaction,
2 = moderate reaction and
3 = severe reaction.
A positive reaction was defined as an erythema/edema
value during the challenge phase of at least one skin grade higher than during the last induction phase
3.
Table 1: Patch test results
Chemical |
No of patients tested |
?+ |
+ |
++ |
Test chemical (2%pet..) |
27 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:
Skin sensitization studies for two structurally similar read across chemicals were conducted in guinea pig using modified Buehler and Klecak method for open epicutaneous testing. In each study, for the induction phase, the left flanks of 10 albino guinea pigs were shaved and the test material was applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration (10.0%, 5.0%, and 2.50%of the induction concentration). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase. No erythema/edema was observed after 24 and 48 hours post-application. Hence the test substances were considered as not sensitizing to the guinea pigs skin.
The above results were further supported by the patch test study performed on another similar read across chemical to determine the allergic contact dermatitis caused by the chemical on human patients. The dye was applied on27patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.None of the treated patients showedany signs ofallergic contact dermatitis. Hencethe test chemical can be considered as non-sensitizer to human skin.
Based on the above summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance andits structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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