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EC number: 230-525-2 | CAS number: 7173-51-5
- 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
Based on the study results, the test substance is considered to be non-sensitizing to skin.
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:
- 6 Dec, 1995 - 5 Jan, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to other 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:
- Buehler test
- Justification for non-LLNA method:
- The study was conducted before the requirement for LLNA testing came into force.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Species: Guinea pigs
Strain: Dunkin Hartley strain, albino guinea pig (SPF-quality)
Source: Charles River, Germany
Sex: Females
Age/weight at study initiation: Approx. 5 weeks 381 - 463 grams
Number of animals per group: 20 animals tested
Control animals: Yes: 10 animals - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction dose: 2 %
Challenge dose: 1 % - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction dose: 2 %
Challenge dose: 1 % - No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction 2 % occlusive epicutaneous
2nd application: Challenge 1 % occlusive epicutaneous - Positive control substance(s):
- yes
- Remarks:
- 1-Chlor-2,4-dinitrobenzol
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% 1-chlor-2,4-dinitrobenzol
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
- Conclusions:
- The test substance was found to be non-sensitizing to the skin in the guinea pigs.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance in guinea pigs following the Buehler protocol. Twenty test guinea pigs were treated on three occasions during 6 h with 2% test substance. Ten control animals were treated with vehicle only. Fourteen days later, all animals were challenged with 1% test substance and vehicle (distilled water). Slight to severe oedema, well defined to severe erythema and necrotic areas were observed in the treated skin in of experimental animals after the third 6 h epidermal induction exposure (Day 15). In the challenge phase, skin reactions of grade 1 were observed in two experimental and two control animals 24 h after exposure only in response to a 1% test substance concentration. No skin reactions were observed in response to the vehicle in any of the experimental and control animals. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that no experimental animals had induced hypersensitivity to the test substance. These results lead to a sensitisation frequency of 0%. Taking into account the intensity of the responses and comparing the test and control animals, it can be concluded that the test substance did not cause hypersensitisation in the guinea pig when tested according to Buehler protocol (NOTOX, 1996).
Reference
Slight to severe oedema, well defined to severe erythema and necrotic areas were observed in the treated skin areas in the experimental animals after the third 6 hours epidermal induction exposure (day 15). In the challenge phase, skin reactions of grade 1 were observed in two experimental and two control animals 24 hours after exposure only in response to a 1% test substance concentration. No skin reactions were observed in response to the vehicle in any of the experimental and control animals. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that no experimental animals had induced hypersensitivity to the test substance. These results lead to a sensitisation rate of 0 per cent.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to determine the skin sensitisation potential of the test substance in guinea pigs following the Buehler protocol. Twenty test guinea pigs were treated on three occasions during 6 h with 2% test substance. Ten control animals were treated with vehicle only. Fourteen days later, all animals were challenged with 1% test substance and vehicle (distilled water). Slight to severe oedema, well defined to severe erythema and necrotic areas were observed in the treated skin in of experimental animals after the third 6 h epidermal induction exposure (Day 15). In the challenge phase, skin reactions of grade 1 were observed in two experimental and two control animals 24 h after exposure only in response to a 1% test substance concentration. No skin reactions were observed in response to the vehicle in any of the experimental and control animals. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that no experimental animals had induced hypersensitivity to the test substance. These results lead to a sensitisation frequency of 0%. Taking into account the intensity of the responses and comparing the test and control animals, it can be concluded that the test substance did not cause hypersensitisation in the guinea pig when tested according to Buehler protocol (NOTOX, 1996).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
DDAC was tested for skin sensitization in the guinea pig according to the Buehler protocol. Based on the results of the study, the test substance can be considered as non-sensitizing to skin, with no classification required according to EU CLP (Regulation EC/1272/2008) criteria.
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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