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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 271-678-5 | CAS number: 68603-87-2
- 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
Endpoint summary
Administrative data
Description of key information
Dicarboxylic acid mixture did not show sensitization properties in a guinea pig maximization 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:
- 2004
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed in 2004, long before the LLNA method was defined as preferred method for skin sensitization testing.
- Specific details on test material used for the study:
- the vehicle chosen was 0.9% NaCl (pyhsiological saline). A hoomogeneous dosage form preparation was obtained at the maximum concentration of 10% (w/w).
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 1-2 months
- Weight at study initiation: 373 ± 10g
- Diet (ad libitum)
- Water (ad libitum):
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30-70%
- Air changes (per hr): 12 cycles per hour
- Photoperiod (hrs dark / hrs light): 12h / 12h
- IN-LIFE DATES: From: March 2004 To: June 2004 - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% (w/w)
- Day(s)/duration:
- day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10%
- Day(s)/duration:
- day 8 (48 hours occlusive)
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- day 22 (24 hour occlusive)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- test group: 10 females
control group: 5 females - Details on study design:
- RANGE FINDING TESTS:
Intradermal route: 10%, 5%, 1% and 0.1% (w/w) in 0.9% NaCl (0.1 mL injection in the interscapular region)
In order to respect the criteria for the selection of concentrations (the concentration should be well-tolerated systemically and locally, intradermal injection should cause moderate irritant effects but no necrosis or ulceration of the skin) concentration chosen for the main study was 0.1% (w/w).
Cutaneous route - for induction: 10% (w/w) in 0.9% NaCl (about 8 cm² fully-loaded filter paper applied occlusively for 48 hours)
Cutaneous route - for challenge: 10% and 5% (w/w) in 0.9% NaCl (applied occlusively for 24 hours); reading 24 and 48 hours after removal of dressing
In order to respect the criteria for the selection of concentrations (the concentration should be well-tolerated systemically and locally, cutaneous application for the challence phase should be the highest concentration which does not cause irritant effect) concentration chosen for the topical application in the induction phase (day8) of main study was 10% (w/w). For the challenge application (day 22), it was 5% (w/w).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal injections with 0.1% test item (day 1; FCA at 50% alone, test item alone, mixture of test item and FCA) and one topical application with 10% test item for 48 hours under occlusive conditions (day 8)
- Control group: only vehicle
As the test item was shown to be non-irritant during the preliminary test, under the conditions of the topical induction phase, the animals of both groups were treated on day 7 with 0.5 mL of sodium lauryl sulfate at the concentration of 10% (w/w) in vaseline, in order to induce local irritation.
B. CHALLENGE EXPOSURE
- No. of exposures: topical application of 0.5% test item
- Day(s) of challenge: day 22
- Exposure period: 24 hours under occlusive conditions
- Control group: only vehicle
- Evaluation (hr after challenge): 24 and 48 hours after patch removal - Challenge controls:
- The animals of the treated and control groups received an application of the test item (test group) and the vehicle (vehicle challenge). The vehicle was applied under the same experimental conditions to the skin of the posterior left flank as challenge control.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the experimental technique is regularly assessed and proven using a known moderate sensitizer, Mercaptobenzothiazole (test of September 2003)
- Positive control results:
- The sensitivity of the experimental technique is regularly assessed and proven using a known moderate sensitizer, Mercaptobenzothiazole (positive skin reactions in 100% (10/10) guinea pigs).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- no data available
- Remarks on result:
- other: The sensitivity of the experimental technique is regularly assessed and proven using a known moderate sensitizer, Mercaptobenzothiazole (test of September 2003)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- no data available
- Remarks on result:
- other: The sensitivity of the experimental technique is regularly assessed and proven using a known moderate sensitizer, Mercaptobenzothiazole (test of September 2003)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- erythema grade 1 in a single animal
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- erythema grade 1 in a single animal
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Executive summary:
Dicarboxylic acid mixture consisting of 18.6% succinic acid, 50.9% glutaric acid, and 23.8% adipic acid, was investigated in a Guinea pig Maximization test performed according to OECD TG 406. Ten guinea pigs received 0.1% test compound in 0.9%NaCl in the presence of Freud's complete adjuvant during the intradermal induction and 10% test compound during the following dermal induction after application of 10% sodium lauryl sulfate to induce local irritation. The challenge was performed with 5% test compound for 24 hours and skin reaction was evaluated 24 and 48 hours after removal of the dressing.
After the challenge application, no cutaneous reactions were observed in the animals of the control group. In the treatment group, a discrete erythema was observed in 1/10 animals at the 24-hour reading and in another animal at the 48-hour reading. Dryness of the skin was also observed in 1/10 animals at the 48-hours reading only. According to the evaluation criteria of the test, the dicarboxylic acid mixture is considered as not exerting skin sensitizing properties.
Reference
After the challenge application, no cutaneous reactions were observed in the animals of the control group. In the treatment group, a discrete erythema was observed in 1/10 animals at the 24-hour reading and in another animal at the 48-hour reading. Dryness of the skin was also observed in 1/10 animals at the 48-hours reading only.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Dicarboxylic acid mixture was investigated in a study according to OECD TG 406; maximization test. Ten guinea pigs received 0.1% test compound in 0.9%NaCl in the presence of Freud's complete adjuvant during the intradermal induction and 10% test compound during the following dermal induction after application of 10% sodium lauryl sulfate to induce local irritation. The challenge was performed with 5% test compound for 24 hours and skin reaction was evaluated 24 and 48 hours after removal of the dressing.
After the challenge application, no cutaneous reactions were observed in the animals of the control group. In the treatment group, a discrete erythema was observed in 1/10 animals at the 24-hour reading and in another animal at the 48-hour reading. Dryness of the skin was also observed in 1/10 animals at the 48-hours reading only. The test item is thus considered as not exerting skin sensitizing properties.
Additional sources/reviews cited in chapter "Additional Toxicological Information" support that dicarboxylic acid mixture is not sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No experimental data concerning the respiratory sensitisation potential are available. Overall, respiratory sensitisation is not expected for dicarboxylic acid mixture.
Justification for classification or non-classification
No classification is required for skin sensitization according to the classification criteria of Regulation no. 1272/2008 (GHS).
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.