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EC number: 223-362-3 | CAS number: 3855-32-1
- 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
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:
- 1991-1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was carried out in accordance with the OECD Guideline No. 406, *Skin Sensitisation*, the EEC Directive 84/449/EEC, Part 8.6, *Skin Sensitisation* and in accordance with the method described by Magnusson and Kligman, 'Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens. A GLP certificate is provided.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The testing using the guinea pig maximisation test protocol was completed on 17 April 2009. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- Preliminary study : 10 females
Experimental group: 20 females
Control group : 10 females - Route:
- intradermal
- Vehicle:
- water
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Details on study design:
- On day 1 an area of the dorsal skin from the scapular region (approximately 4 x 6 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mllsite) were made at the border of a 2 x 4 cm area in the clipped region as follows:
A) The test substance diluted to 0.1 % (wlw) with physiological saline,
B) Freunds' Complete Adjuvant (FCA, Difco, Detroit, U.S.A.), 50:50 with distilled water for injection (pyrogen free).
C) The test substance, at twice the concentration used in (A), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant. - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde (sensitivity check)
- Positive control results:
- Clear positive results after challenge with 0.25% formaldehyde in distilled water.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals during the study.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals during the study.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .
- Reading:
- other: Controls
- Group:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals during the study.
- Remarks on result:
- other: Reading: other: Controls. Group: negative control. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. .
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions used in this study, treatment with the substance resulted in a sensitisation rate of 25 per cent.
Applying the rating of allergenicity described by Kligman A.M. (1966) on the results obtained in this test, the substance is considered to have mild sensitising properties. However, it does not meet the criteria for classification (≥ 30 % responding at > 1 % intradermal induction dose ). See ECHA Guidance on the Application of the CLP Criteria
Reference
CONTROL GROUP:
Eight, one and one animal showed a skin reaction in response to the 2%, 1% and 0.5% test substance concentration, respectively. These skin reactions were characterised by red spots, scaliness.
EXPERIMENTAL GROUP:
Sixteen, one and two animals showed a skin reaction in response to the 2%, 1% and 0.5% test substance concentrations, respectively. These reactions were characterised by redness, crust, swelling and scaliness. Taking into account the intensity of the responses and comparing these with the reactions seen in the control animals, five animals showed a positive skin reaction in response to the 2% concentration.
No symptoms of systemic toxicity were observed in the animals during the study.
No mortality occurred during the study.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The substance does not need to be classified according to classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008.
Migrated from Short description of key information:
In a Guinea-Pig Maximization Test, the substance resulted in a sensitisation rate of 25 per cent. This does not meet the criteria for classification (≥ 30 % responding at > 1 % intradermal induction dose ). See ECHA Guidance on the Application of the CLP Criteria.
The substance is severely corrosive to the skin of rabbits, a factor that must be considered in interpretation of the study results. Tthe substance is not considered to be a sensitiser.
Justification for selection of skin sensitisation endpoint:
This study was carried out in accordance with the OECD Guideline No. 406,
*Skin Sensitisation*, the EEC Directive 84/449/EEC, Part 8.6, *Skin Sensitisation* and in accordance with the method described by Magnusson and Kligman, 'Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a Guinea-Pig Maximization Test, the substance resulted in a sensitisation rate of 25 per cent.
This does not meet the criteria for CLP classification (≥ 30 % responding at > 1 % intradermal induction dose ).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.