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EC number: 428-320-1 | CAS number: 71308-16-2
- 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
Skin sensitisation
Administrative data
- 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:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- 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
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid - liquid: suspension
In vivo test system
Test animals
- Strain:
- other: Crl:(HA)BR
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 3 weeks
- Housing: 4 cages, one cage per group of at most 10 animals
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 62.5-92.5%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17.10.1995 To: 17.11.1995
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- 1. induction: 3%
2. Induction: 50%
1. Challenge: 12.5 and 25%
2. Challenge: 12.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 1. induction: 3%
2. Induction: 50%
1. Challenge: 12.5 and 25%
2. Challenge: 12.5%
- No. of animals per dose:
- control: 3 males and 3 females
treated group: 5 males and 5 females - Details on study design:
- RANGE FINDING TESTS:
intradermal injection with various concentrations in 3 animals for screening of mild irritating and well tolerated concentration
irritation response after tocical treatment was tested in 6 animals (naive) and 6 animals (FCA treated), reading for irritation response 24 h and 48 h after patch removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Site: dorsal skin in the skapular region
- Exposure period: intradermal injection, topcial application 7 days later for 24 h
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1 day application period, 1. Challenge 2 weeks after topical induction, rechallenge one week later; reading 24 and 48 h after pach removal
- Site: topcial application; 1. Challenge: 12.5% left flank, 25% right flank of animals; Rechallenge: left flank with 12.5% and diluent, avoiding overlapping with the site challenged one week before
- Concentrations: 12.5 and 25% (1. challenge), 0%, 12.5% rechallenge
- Evaluation (hr after challenge): 24 h - Positive control substance(s):
- yes
- Remarks:
- benzocaine
Results and discussion
- Positive control results:
- A challenge treatment of 30% benzocaine in vaseline caused positive reations in 50% of the test animals, no reaction in the controls.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5%. No with. + reactions: 7.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- very slight erythema (grade 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12.5%. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight erythema (grade 1).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Clinical observations:
- very slight erythema (grade 1)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 12.5%. No with. + reactions: 3.0. Total no. in groups: 6.0. Clinical observations: very slight erythema (grade 1).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 6.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 6.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: maize oil alone
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: maize oil alone. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: maize oil alone
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: maize oil alone. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions tested, a challenge concentration of 12.5% of the test substance causes dermal effects in 60% of the animals, whereas a concentration of 25% showed 30% response only. This might be explained by a difference in skin penetration. A re-challenge resulted in a lesser response (less animals affected as well as weaker skin reactions). Therefore, the test substance is regarded as skin sensitizer.
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