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EC number: 222-326-4 | CAS number: 3426-43-5
- 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
Not sensitising in a Guinea pig maximisation test.
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:
- From March 10 to June 3, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guine pig maximisation test was available.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: at delivery, no parasites, pathogenic microorganisms, viruses and fungi
- Weight at study initiation: 300 - 385 g
- Housing: group of 5 per cage
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Controlled temperature
- Controlled humidity
- Air changes: automatic ventilation
- Photoperiod: 12 hrs light - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5 % in water
0.5 % in complete Freund's adjuvant in water 1:1 - Day(s)/duration:
- day 0
- Adequacy of induction:
- other: highest concentration causing no skin irritation
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Details on study design:
- RANGE FINDING TESTS: animals were exposed epicutaneously to test substance, using a filter paper saturated with 0.5 %, 1 % and 5 % solutions of water for injection, fixed by an occlusive bandage for 24 hours.
1 hour after removal of the bandage and sample, local irritation was evaluated and it was found that 0.5 % in water for injection was not irritating to guinea pigs, whil weak signs of irritation were noted at the 2 highest concentrations..
MAIN STUDY
A. INDUCTION EXPOSURE: intradermal
- Test groups: 20 females
- Control group: 10 females
- Site: shaved neck area
- Frequency of applications: 3 injections of 0.1 ml
- Duration: on day 0
- Concentrations: Freun'd complete adjuvant; 0.5 % test substance in water; 0.5 % test substance in 1:1 water and complete Freund's adjuvant
A. INDUCTION EXPOSURE: epicutaneous
- Test groups: 20 females
- Control group: 10 females
- Site: shaved neck area
- Frequency of applications: 1
- Duration: on day 7, for 48 hours
- Concentrations: 25 % in vaseline
B. CHALLENGE EXPOSURE 1: epicutaneous
- Day of challenge: 20
- Exposure period: 24 h
- Test groups: 20 females
- Control group: 10 females
- Site: right flank
- Concentrations: 0.5 %
- Evaluation: 1, 24, 48 and 72 h after removal of the bandage
B. CHALLENGE EXPOSURE 2: epicutaneous
- Day of challenge: 27
- Exposure period: 24 h
- Test groups: 20 females
- Control group: 10 females
- Site: left flank
- Concentrations: 0.5 %
- Evaluation: 1, 24, 48 and 72 h after removal of the bandage and washing with water to eliminate residues - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: not reported
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- Non skin sensitising.
- Executive summary:
Method
Guinea pig maximisation test using 20 females in test group and 10 females in control group. Intradermal induction was done on day 0 using a 0.5 % solution of test substance. This concentration was chosen in a preliminary test using water solutions at 0.5 %, 1 % and 5 %. Epidermal induction was done on day 7, using a 0.5 % solution of test substance. First epidermal challenge was conducted on day 20, by occlusive epicutaneous application of a 0.5 % solution of test substance for 24 hours. Evaluation for responses was carried out 1, 24, 48 and 72 hours after removal of the bandage. A second epidermal challenge was carried out on day 27 to avoid false negative results, under the same test conditions.
Results
The 0.5 % solution was found to be the highest non irritating concentration tested in the preliminary test on irritation. Upon challenge, on day 20 and on day 27, no positive responses were reported, in both test group and control group.
Reference
Primary dermal irritation test
concentration | erythema | oedema |
5% | 1 | 2 |
1 | 1 | |
1% | 1 | 1 |
1 | 1 | |
0.5 % | 0 | 0 |
0 | 0 | |
25% in vaseline | 2 | 3 |
1 | 2 |
0 without
reaction
1
very
weak erythema, very weak oedema
2
weak
erythema, weak oedema
3
mean
erythema, mean oedema
4
strong
erythema, strong oedema
Negative controls
No signs of irritation in terms of erythema and/or oedema were noted after first and second challenge in negative controls.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No positive responses were found in guinea pigs in a maximisation test using OB 134 according to OECD guideline 406.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), skin sensitiser is a substance that will lead to an allergic response following skin contact. In case of a guinea pig maximisation test, a response of at least 30 % of the animals is considered as positive.
Under the experimental conditions employed, 0 % of the animals of the test and control groups showed skin reactions 24, 48 and 72 hours upon challenge with test substance at 0.5 % concentration, thus no classification applied.
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