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EC number: 203-856-5 | CAS number: 111-30-8
- 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
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to the implementation of the actual guidelines and GLP was not compulsory at the time the study was performed. However, the study was based on an acknowledged standardized test method and was conducted according to an acceptable BASF test; basic data were given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- BASF test:
The aim of the present test was to look for the sensitizing potential of glutaraldehyde using the open epicutaneous test with guinea pig, which is an acknowledged standardized test method.
For induction, the unchanged test substance was applied to the shaved left flank (area 25 cm2) of 10 Pirbright White Guinea pigs. Application was performed once daily, for 5 consecutive days, over 2 weeks (total of 10 applications). The shaved right flank remained untreated.
Following an 11-day recovery period, both flanks were shaved once again and the unchanged test substance was applied, this time to the right flank of each treated animal (single application). Three control animals, which had not been previously subjected to induction, were treated similarly. Skin reactions were recorded after 12 hours. - GLP compliance:
- no
- Remarks:
- ; GLP was not compulsory at the time the study was performed.
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The study was performed in 1975, before the LLNA OECD TG 429 was in place (adopted in 2002).
Test material
- Reference substance name:
- Glutaral
- EC Number:
- 203-856-5
- EC Name:
- Glutaral
- Cas Number:
- 111-30-8
- Molecular formula:
- C5H8O2
- IUPAC Name:
- glutaraldehyde
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Glutaraldehyde 25% aq. solution
- Physical state: liquid
- Analytical purity: 25.0% glutaraldehyde
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White guinea pigs
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- The application area was a skin area of 25 cm2
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- The application area was a skin area of 25 cm2
- No. of animals per dose:
- Treated females: 10
Control females: 3 - Details on study design:
- INDUCTION EXPOSURE
- No. of exposures: 10 applications
- Exposure period: 2 weeks
- Test groups: one group comprising 10 animals
- Site: left flank, clipped 25 cm2 area within the fore region; the shaved right flank remained untreated
CHALLENGE EXPOSURE
- No. of exposures: single application
- Day(s) of challenge: challenge was conducted after a recovery period of 11-day following induction
- Exposure period: 12 hours
- Test groups: one induced group comprising 10 animals
- Control group: Three control animals, which had not been previously subjected to induction, were challenged.
- Site: both flanks were shaved again and the unchanged test substance was applied, this time to the right flank of each treated animal
- Evaluation (hr after challenge): after 12 hours following challenge
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- test chemical
- Dose level:
- single application of glutaraldehyde 25% on a skin area of 25 cm2
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- All animals showed slight spot-like redness of the skin and brownish residues of the test substance.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- negative control
- Dose level:
- single application of glutaraldehyde 25% on a skin area of 25 cm2
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- None of the control animal showed skin reaction. Brownish test substance residues on the skin were seen.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Repeated induction treatment with the undiluted test substance caused necrotic skin lesions with thick bloody
crusts in all animals. Upon challenge treatment of the opposite flank with the undiluted test substance performed
after an 11-day period without treatment, all animals exhibited slight erythema. No signs of irritation were seen
in the three untreated controls.
Applicant's summary and conclusion
- Conclusions:
- Glutaraldehyde 25% was sensitizing to guinea pig when tested in the open epicutaneous test.
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