Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-593-6 | CAS number: 108-55-4
- 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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A Guinea Pig Maximization Test (M&K method ) was already available before the LLNA test became available.
Test material
- Reference substance name:
- Glutaric anhydride
- EC Number:
- 203-593-6
- EC Name:
- Glutaric anhydride
- Cas Number:
- 108-55-4
- Molecular formula:
- C5H6O3
- IUPAC Name:
- glutaric anhydride
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Test Material : Glutaric Anhydride
- Lot/Batch No.: Truck #2
- Description: White solid
- Date of Receipt: November 1, 1991
- Expiration Date: Not provided
- Received from : Union Carbide
- Storage: Room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Test animals
- Age: approximately 2-3 weeks at receipt, approximately 4-5 weeks old at study initiation.
Observations: All animals were checked for viability twice daily. Prior to assignment to study a1 1 animals received a physical examination to ascertain suitability for study.
- Husbandry: Currently acceptable practices of good animal husbandry were followed, e.g., Guide for the Care and Use of Laboratory Animals; NIH Publication No. 86-23, revised 1985.
- Housing : Individually, in suspended, stainless steel cages with wire mesh bottoms.
- Environmental conditions:
1. Temperature: monitored and recorded twice daily.
2. Humidity: monitored and recorded daily
3. Light Cycle: 12 hours light, 12 hours dark (controlled by an automatic timer).
- Food : Agway Purina Guinea Pig Diet, ad libitum
- Water: Automatic watering system, gSd libitum. Municipal water supply (El izabethtown Water Company, Westfield, New Jersey).
- Contaminants: There were no known contaminants reasonably expected to be found in food or water which would interfere with the results of this study.
- Animal Identification: Each animal was identified with a ear tag, bearing a unique animal number, prior to testing.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol (70%)
- Concentration / amount:
- intradermal induction - 5%
topical induction and challenge - 50% test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol (70%)
- Concentration / amount:
- intradermal induction - 5%
topical induction and challenge - 50% test substance
- No. of animals per dose:
- Range Finding study: 8 animals (4/sex)
Sensitisation study:
20 animals (10 per sex) for sensitisation
10 animals (5 per sex) for irritation control - 1st challenge
10 animals (5 per sex) for irritation control - Re-challenge
Main study: positive control:
10 animals (5 per sex); irritation control for positive control group - 10 animals (5 per sex)
68 animals in total - Details on study design:
- RANGE-FINDING STUDY
1. Intradermal
To confirm that the concentration proposed for intradermal injection (5.0%) did not produce extensive necrosis or ulceration or severe systemic toxicity, two animals were administered intradermal injections (2 sites per animal) of a 5.0% v/v concentration of the test material in propylene glycol. Injections of 0.1 ml per site were made intradermally using a 1.0 cc syringe and a 25 gauge 5/8" needle. Observations were made at 24- and 48-hours for necrosis and ulceration. Results indicated that a 5.0% concentration produced no necrosis or only local necrosis, no extensive necrosis or
ulceration occurred). Therefore, this concentration was used for the intradermal induction administration.
2. Topical
A topical range-finding study was performed as follows to determine the lowest concentration which produced mi ld irritation (to be used for induction) and the highest concentration which did not produce irritation (to be used for chal lenge) . Number of Animals: 6 (3/sex) Vehicle: 70% ethanol
Concentrations: 10, 25 and 50% w/v; 100%, moistened with 0.9% sterile saline. Based on the results of this study, the test material was found to be essentially non-irritating. Although Magnusson and Kligman (1970) suggest dosing solids at a maximum concentration of 25%, a 50% concentration in 70% ethanol was selected for topical induction and both challenges, to maximize the response. A dose of 100% moistened with saline was not selected, due to a concern there may be poor absorption.
MAIN STUDY
1. Induction, intradermal :
Site One: Adjuvant: 10 or 3 ml of FCA was added to 10 or 3 ml of deionized water and mixed, to produce a 0.5 ml/ml (50% v/v) mixture).
Site Two: Positive Control: 0.01 g of DNCB was added to propylene glycol which was brought to a total volume of 10 ml to produce a 0.001 g/ml (0.1% w/v) mixture. Test Material: 0.5 g of Glutaric Anhydride was added to propylene glycol which was brought to a total volume of 10 ml to produce a 0.05 g/ml (5% w/v) mixture. Irritation Controls : Propylene glycol was administered as received.
Site Three: Positive Control: 0.01 g of DNCB was added to a 50% mixture of FCA in deionized water which was brought to a total volume of 10 ml to produce a 0.001 g/ml (0.1% w/v) mixture. Test Material: 0.5 g of Glutaric Anhydride was added to a 50% mixture of FCA in deionized water, which was brought to a total volume of 10 ml, to produce a 0.05 g/ml (5% w/v) mixture. Irritation Controls: Site Three dosed with same mixture as site one.
2. Induction, topical
Positive Control: 0.01 g of DNCB was added t o 70% ethanol which was brought t o a t o t a l volume of 10 ml t o produce a 0.001 g/ml (0.1% w/v) mixture. Test Material: 5 g of Glutaric Anhydride was added to 70% ethanol, which was brought to a total volume o f 10 ml , to produce a 0.5 g/ml (50% w/v) mixture. Irritation Controls: 70% ethanol as prepared. Enhancer: 4 g of sodium lauryl sulfate was added to petrolatum, which was brought to a total weight of 40 g, to produce a 0.1 g/g (10% w/w) mixture.
Challenge/Rechallenge:
Test material and irritation control animals both received a 50% concentration prepared in the same manner as for the induction exposure. - Challenge controls:
- Test material and irritation control animals both received a 50% concentration prepared in the same manner as for the induction exposure.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dintrochlorobenzene
Results and discussion
- Positive control results:
- Nine of the ten animals treated with 0.1% DNCB exhibited clear dermal responses (scores of 1 or greater) at challenge, as confirmed by a lack of response by control animals (Group IB) to the same concentration. This 90% response would categorize this material as an extreme sensitizer (Grade V) .This positive response to a known sensitizer demonstrates the susceptibility of this group of animals to sensitization in the guinea pig maximization test.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: DNCB, irritation contriol
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: DNCB, irritation control
- Dose level:
- 01.%% DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- 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:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under conditions of this study, glutaric anhydride exhibited no potential to produce dermal sensitization in the guinea pig. Based on the 0% incidence of sensitization, glutaric anhydride would not be categorized as a sensitizer.
- Executive summary:
This study was conducted in order to evaluate the allergic contact sensitization potential of glutaric anhydride in guinea pigs. This study was performed, using procedures based on the method described by Bertil Magnusson, M.D., and Albert M. Kligman, M.D., Ph.D. in "The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test", Journal of Investigative Dermatology, 57: 268-276 and in Allergic Contact Dermatitis in the Guinea Pig, Identification of Contac Allergens, Thomas, Springfield, IL, 1970.
Under conditions of this study, glutaric anhydride exhibited no potential to produce dermal sensitization in the guinea pig. Based on the 0% incidence of sensitization, glutaric anhydride would not be categorized as a sensitizer.
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.