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EC number: 406-700-6 | CAS number: 78531-61-0
- 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
OECD 406, guinea pig: sensitising (reference 7.4.1 -1)
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:
- 1990-09-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Remarks:
- OET (Open Epicutaneous Test)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1990 when the LLNA was not an established test method yet.
- Species:
- guinea pig
- Strain:
- other: gpg, Iva:PDH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specified
- Age at study initiation: 5 weeks
- Weight at study initiation: mean 300 g (range: 237 - 349 g)
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 30 °C
- Humidity: 38 - 70 %
- Air changes: not specified
- Photoperiod: 12 / 12 hrs dark / hrs light - Route:
- other: open epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0 % (control)
3 % (1. challenge group)
10 % (2. challenge group) - Route:
- other: open epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- a) 1. Challenge: 0, 1 %, 3 % und 10 % in Paraffin
b) 2. Challenge: 0, 1 %, 3 % und 10 % in Paraffin - No. of animals per dose:
- Number of animals in test group: 6
Number of animals in negative control group: 6 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: once daily for 21 days
- Exposure period: topical application; no washing
- Test groups: 2
- Control group: 2
- Site: back
- Frequency of applications: once daily
- Concentrations: 3 and 10 %
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 22 and day 36
- Exposure period: topical application; no washing
- Test groups: 2
- Control group: 2
- Site: left or right flank
- Concentrations: 1, 3, and 10 %
- Evaluation: 24, 48, 72 h after administration
- Challenge controls:
- yes
- Positive control substance(s):
- no
- Positive control results:
- not applicable
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the findings of this study, the test item is considered a skin sensitiser.
- Executive summary:
The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET). Four groups with 6 female guinea-pigs, each, were investigated:
Group 1 and group 2 were controls. Group 3 was treated with 0.1 mL of 3 % test item,
and group 4 with 0.1 mL of 10 % test item during the 21 day induction phase.
During this period erythema and/or scales were observed at the treated skin sites in groups 2-4. After the first challenge on day 22 with 1, 3, and 10 % test material concentrations, only one animal of group 3 showed a skin reaction to the 3 % preparation. After the second challenge with the same concentrations, skin reactions to the vehicle or to the test material were seen in some animals of all groups. Sensitization, however, was only indicated in group 3 to the 3 % and 10 % test material preparations. The test item should therefore be classified as a sensitizer.
Reference
Maximum concentration not causing irritating effects in preliminary test: 3 %
Evidence of sensitisation of each challenge concentration:
Challenge 1: no animal assessed as sensitizing
Challenge 2: 4/6 and 3/6 respectively
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Open epicutaneous test in guinea pigs, reference 7.4.1 -1
The test item was tested for skin sensitizing activity in guinea pigs in the Open Epicutaneous Test (OET). Four groups with 6 female guinea-pigs, each, were investigated:
Group 1 and group 2 were controls. Group 3 was treated with 0.1 mL of 3 % test item,
and group 4 with 0.1 mL of 10 % test item during the 21 day induction phase.
During this period erythema and/or scales were observed at the treated skin sites in groups 2-4. After the first challenge on day 22 with 1, 3, and 10 % test material concentrations, only one animal of group 3 showed a skin reaction to the 3 % preparation. After the second challenge with the same concentrations, skin reactions to the vehicle or to the test material were seen in some animals of all groups. Sensitization, however, was only indicated in group 3 to the 3 % and 10 % test material preparations. The test item should therefore be classified as a sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin sensitisation the test item is classified and
labelled as skin sensitiser cat 1 (H317: "May cause an allergic skin
reaction") according to Regulation (EC) No 1272/2008 (CLP), as amended
for the twelfth time in Regulation (EU) 2019/521.
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