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Diss Factsheets
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EC number: 201-818-2 | CAS number: 88-30-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin:
In a primary skin sensitation study in guinea pigs similar to OECD guideline 406, the test substance showed no skin sensitizing potential (Hazleton Laboratories, 1990).
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:
- 1990-05-31 to 1990-08-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Principles of method if other than guideline:
- According to Buehler et al., 1980
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was conducted before the implementation of OECD 429 in 2002.
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
OTHER SPECIFICS: dark brown liquid - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc.
- Microbiological status of animals, when known: SPF
- Age at study initiation: young adult
- Weight at study initiation: 446 - 550 g
- Housing: individually, in screen-bottom stainless steel cages
- Diet: ad libitum, certified guinea pig chow #5026 (Purina Mills, Inc.)
- Water: ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 1990-06-06 To: 1990-07-16 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 0.4 mL, 1.0 % w/v
- Day(s)/duration:
- day 0, day 7, and day 14; 6 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- 0.4 mL, 0.1 % w/v
- Day(s)/duration:
- 2 weeks after last induction; 6 h
- No. of animals per dose:
- Test group: 10
Naive control group: 10
positive control group: 4 - Details on study design:
- RANGE FINDING TESTS:
yes, two range finding groups, 4 animals each.
1st group: undiluted, 75 % w/v, 50 % w/v, 25 % w/v
Due to the level of irritation, a second range finding study ws conducted
2nd group: 10 % w/v, 5 % w/v, 1 % w/v, 0.1 % w/v
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 1
- Control group: 2, naive and positive control
- Site: back of the animals
- Frequency of applications: once a week
- Duration: 3 week
- Concentrations: 1.0 % w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after the last inducton exposure
- Exposure period: 6 h
- Test groups: 1
- Control group: 2, naive and positive control
- Site: back of the animals
- Concentrations: 0.1 % w/v
- Evaluation (hr after challenge): 24, 48 - Positive control substance(s):
- yes
- Remarks:
- 0.3 % w/v 2,4-dinitrochlorobenzene (DNCB) in 80 % ethanol/deionized water
- Positive control results:
- The mean score of DNCB (all animals) 24 h after challenge was 2.0 (max. score 3.0).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- subcutanous hemorrhaging, possible necrotic areas
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- subcutanous hemorrhaging, possible necrotic areas
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1 w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed no skin sensitizing potential.
- Executive summary:
In a primary sensitisation study similar to OECD guideline 406, a group of young adult Dunkin-Hartley guinea pigs (10♂, 446 - 550 g) were epicoutanously treated with the test substance (3x 0.4 mL, 1.0 % w/v in deionized water, once a week for 6 h) at the back (Hazleton Laboratories, 1990). After an incubation period of 2 weeks, the animals were challenged with 0.4 mL of a 0.1 % w/v water solution for 6 h at the back. Readings were done 24 and 48 h after the challenge injection. The sensitizing score was determined according to Buehler et al. (1980). The test substance caused no sensitisation response. A positive control group of 4 animals was treated with 2,4-dinitrochlorobenzene (0.3 % w/v in 80 % ethanol/dionized water). All animals of the positive control group showed signs of sensitisation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a primary sensitisation study similar to OECD guideline 406, a group of young adult Dunkin-Hartley guinea pigs (10♂, 446 - 550 g) were epicoutanously treated with the test substance (3x 0.4 mL, 1.0 % w/v in deionized water, once a week for 6 h) at the back (Hazleton Laboratories, 1990). After an incubation period of 2 weeks, the animals were challenged with 0.4 mL of a 0.1 % w/v water solution for 6 h at the back. Readings were done 24 and 48 h after the challenge injection. The sensitizing score was determined according to Buehler et al. (1980). The test substance caused no sensitization response. A positive control group of 4 animals was treated with 2,4-dinitrochlorobenzene (0.3 % w/v in 80 % ethanol/deionized water). All animals of the positive control group showed signs of sensitisation.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
The substance is considered not to be classified for sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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