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EC number: 204-857-3 | CAS number: 127-68-4
- 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 skin sensitization potential of test chemical was assessed in various experimental studies conducted on guinea pigs. Based on the available data for the target and supporting studies, it can be concluded that the test chemical is able to cause skin sensitization and thus can be considered as sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Skin Sensitizer”.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data is from experimental study report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- A maximization test was carried out in female Dunkin-Hartley guinea pigs to assess the skin sensitization potential of test chemical according to EU Method B.6 (Skin Sensitisation).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Body weight at the beginning of the study : 275 - 310 g
Acclimatization period: At least 7 days before the beginning of the study in the laboratory for dermal toxicity.
The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%.
The illumination period was 12 h dark and 12 h light.
Type of cage: Makrolon, type IV
No . of animals per cage: 5
Identification of the animals: Ear tag numbering
Type of diet: Kliba 341.4 mm
Water was available ad libitum (tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week) - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 1st application: Induction 5 % intracutaneous;
2nd application: Induction 50 % occlusive epicutaneous - Day(s)/duration:
- 96 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% in aqua bidest.
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% in aqua bidest.
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- control: 5
test group: 10 - Details on study design:
- For detecting a possible influence on irritating effects of previous intradermal treatment with Freund's adjuvant, animals pretreated with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) each, in the same manner as intradermal induction about 3 weeks prior to the application of the test substance were used.
In the preliminary test after two 24-hour percutaneous occlusive applications within 96 hours the minimum irritant concentration was found to be a 50% test substance preparation in aqua bidest. and the maximum non-irritant concentration a 25% test substance preparation in aqua bidest. (48 hours after the beginning of application).
Applicability: It was possible to inject a 5% test substance preparation in 0.9% aqueous NaCl-solution resp. in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) with a syringe. - Positive control substance(s):
- yes
- Remarks:
- (1-chlor-2.4-dinitro-benzol)
- Reading:
- other: 1st percutaneous challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- moderate to severe erythema and very slight edema; well-defined erythema could be observed in 2 out of 10 animals.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 2nd challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- moderate to severe erythema and very slight edema; well-defined erythema (1 animal with very slight erythema.
- Remarks on result:
- positive indication of skin sensitisation
- Cellular proliferation data / Observations:
- moderate to severe erythema and very slight edema; well-defined erythema could be observed in 2 out of 10 animals.
- Interpretation of results:
- other: sensitising
- Conclusions:
The number of animals sensitized is primarily taken into account in the evaluation. The control animals are used to rule out any substance-induced primary skin irritation.
The findings obtained 24 hours after the removal of the patch are taken into account for the determination of the sensitization rate.
The evaluation "sensitizing" results if at least 30 per cent of the animals exhibit skin reactions in this adjuvant test.
Under the test conditions chosen and following the described results, the test chemical has a sensitizing effect on the skin of the guinea pig.- Executive summary:
A maximization test was carried out in female Dunkin-Hartley guinea pigs to assess the skin sensitization potential of test chemical according to EU Method B.6 (Skin Sensitization). In the preliminary test after 24-hour percutaneous occlusive applications within 96 hours, the minimum irritant concentration was observed to be a 50% of test substance preparation in water and the maximum non-irritant concentration was 25% test substance preparation in water (48 hours after the beginning of application).The test was conducted on 10 guinea pigs in test group and 5 guinea pigs in control group. During the induction, the animals were treated intracutaneously at concentration of 5 % and dermally at concentration 50 % under occlusive condition. Later, challenge and rechallenge was performed at a dose of 25% of test chemical in water under occlusive condition and skin reactions were observed. Also 1-chlor-2.4-dinitro-benzol was used as positive control. The findings revealed, moderate to severe erythema, very slight edema and well-defined erythema in 2 out of 10 animals. Thus under the test conditions chosen and the described results, the test chemical was considered as sensitizing to the skin of the guinea pig.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Various studies has been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pigs for test chemical .The predicted data using the Danish QSAR database has also been compared with the experimental data and summarized as below;
A maximization test was carried out in female Dunkin-Hartley guinea pigs to assess the skin sensitization potential of test chemical according to EU Method B.6 (Skin Sensitization). In the preliminary test after 24-hour percutaneous occlusive applications within 96 hours, the minimum irritant concentration was observed to be a 50% of test substance preparation in water and the maximum non-irritant concentration was 25% test substance preparation in water (48 hours after the beginning of application).The test was conducted on 10 guinea pigs in test group and 5 guinea pigs in control group. During the induction, the animals were treated intracutaneously at concentration of 5 % and dermally at concentration 50 % under occlusive condition. Later, challenge and rechallenge was performed at a dose of 25% of test chemical in water under occlusive condition and skin reactions were observed. Also 1-chlor-2.4-dinitro-benzol was used as positive control. The findings revealed, moderate to severe erythema, very slight edema and well-defined erythema in 2 out of 10 animals. Thus under the test conditions chosen and the described results, the test chemical was considered as sensitizing to the skin of the guinea pig.
Another Skin sensitization study of chemical was reported by in guinea pigs by using maximization test according to Directive 84/449/EEC, B.6 "Acute toxicity (skin sensitization)". Since the chemical caused skin sensitizing effects in treated guinea pigs, the test chemical was considered to be sensitizing to the skin of guinea pigs.
The overall results were further supported by the predicted data estimated by Danish QSAR database. According to Danish QSAR database, the skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, skin sensitization reactions were observed in guinea Pig and Human. Therefore, the test chemical was considered to be sensitizing.
Thus based on the above key and supporting studies for test chemical, it can be concluded that the test chemical is able to cause skin sensitization. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Skin Sensitizer”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance were observed in various studies. From the results obtained from these studies it is concluded that the test chemical is likely to cause skin sensitization and hence can be classified as “Skin Sensitizer”.
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