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EC number: 208-010-9 | CAS number: 505-48-6
- 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:
- 2018-08-13 - 2018-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test was sponsored by supplier in India. Since no other data is available no new animal study was performed.
Test material
- Reference substance name:
- Suberic acid
- EC Number:
- 208-010-9
- EC Name:
- Suberic acid
- Cas Number:
- 505-48-6
- Molecular formula:
- C8H14O4
- IUPAC Name:
- octanedioic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Molecular formula: C8H14O4
Molecular Mass:
174.20
Characteristics (Physical Appearance):
White Crystalline powder
CAS No.:
505-48-6
Batch Number:
308
Purity:
100%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Animal Species
and rationale for selection:
Guinea pig (Cavia porcellus); Guinea pig has been the animal of choice for predictive Sensitisation tests, and is the species preferred by the regulatory guidelines.
Strain
and rationale for selection:
English (Hartley); The strain has been selected due to its availability in requisite numbers.
Source:
Sri Raghavendra Enterprises, Bangalore, India
Age at the start of the study:
13 weeks
Sex:
Female; females were nulliparous and non-pregnant.
Body weight range (Day -1):
329 g to 496 g
Number of animals used:
Pilot Study - 2 animals;
Main study - 30 animals;
(Treatment group - 20 animals; Control group - 10 animals)
Veterinary Examination:
Prior to final assignment to the study, the animals were subjected to a veterinary examination to ensure that the selected guinea pigs were in a good state of health.
HOUSING AND FEEDING CONDITIONS Accommodation : Animals were housed in room number AR-04, in the experimental animal facility of INTOX PVT. LTD., maintained under appropriate barriers. Animals were housed singly in solid bottom polypropylene cages [size: 42 cm (L) x 29 cm (W) x 19 cm (H)] with stainless steel grill tops, facilities for food and water bottle, and bedding of clean and sterilized paddy husk. The cages were suspended on stainless steel racks.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: analytical grade water with 0.2% Tween 80
- Concentration / amount:
- 56% w/v of SUBERIC ACID
- Day(s)/duration:
- 0,7,14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: analytical grade water with 0.2% Tween 80
- Concentration / amount:
- 56%
- Day(s)/duration:
- day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Challenge controls:
- analytical grade water with 0.2% Tween 80
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 56%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 56%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The allergic contact sensitisation potential of SUBERIC ACID was assessed in guinea pigs as per the method described by Buehler E. V., in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 406 - Skin sensitisation, adopted by the council on 17 July 1992.
In this test, induction of sensitisation was attempted by exposing the guinea pigs to 56% w/v of SUBERIC ACID in analytical grade water with 0.2% Tween 80 on days 0, 7 and 14 by epidermal route on the clipped left flank area, there was no evidence of erythema and / or swelling at the site of application. After an induction period of 14 days, the animals were similarly subjected to a ‘challenge application’ with 56% w/v of SUBERIC ACID in analytical grade water with 0.2% Tween 80 on day 28 of the study, on their right flank.
In absence of a sensitisation response in any of the treated animals to challenge by the test item, SUBERIC ACID is classified as non sensitiser to guinea pigs as per the criteria of classification for the Buehler test (Kimber et. al., 1990). - Executive summary:
The skin sensitisation potential of SUBERIC ACID was assessed in guinea pigs as per the method described by Buehler E. V., in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 406 – Skin sensitisation, adopted by the council on 17 July 1992.
In this study, based on the results of a pilot study, induction of sensitisation was attempted by exposing the guinea pigs to 56% w/v of SUBERIC ACID in analytical grade water with 0.2% Tween 80 on days 0, 7 and 14 by epidermal route on the clipped left flank area. After an induction period of 14 days, the animals were similarly subjected to a ‘challenge application’ with 56% w/v of SUBERIC ACID in analytical grade water 0.2% Tween 80 on day 28 of the study, on their right flank. Treated group comprised of 20 animals and control group comprised of 10 animals.
Skin reaction was recorded at 24 and 48 hours after removal of each induction patch and was also evaluated at 24 and 48 hours after removal of the challenge patch. The guinea pigs were examined for survival and abnormal clinical signs daily during the study, and their body weights were recorded at start and termination of the experiment.
In this study all guinea pigs survived throughout the duration of the study. Clinical observations made periodically during the study revealed that, test item did not induce any signs of systemic toxicity in the exposed animals. There was no adverse effect of the treatment on the body weight gain by the exposed guinea pigs.
Skin Reaction Following Induction Applications
As revealed at 24 and 48 hours after removal of each induction patch for the induction applications made on days 0, 7 and 14, the test item did not induce any skin reaction on the site of application in the treated guinea pigs.
Skin Reaction Following Challenge Application
After challenge application made on day 28, as observed on days 29 and 30, there was no evidence of any acute dermal response at the site of application in the form of erythema and / or swelling in all animals from the control and the treatment groups.
Conclusion
In absence of a sensitisation response in any of the treated animals to challenge by the test item, SUBERIC ACID is classified as non sensitiser to guinea pigs as per the criteria of classification for the Buehler test (Kimber et. al.,1990).
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