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EC number: 617-084-5 | CAS number: 80474-45-9
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Read-across from Thioacid:
Thioacid was tested for potential contact allergenicity by repeated dermal applications of a 10% w/v solution in 96% ethanol/methyl cellosolve/Tween 80, 45:45:10 parts per volume. 9/10 animals responded positively to challenge with a 5% w/v solution of the test material. In the test system used, thioacid was strongly skin sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987-04-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Read-across
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was intended to provide evidence on the potential hazards of human skin contact with the test material, GR46580X. The test material was assessed for potential contact sensitivity by the topical method of Levine (1960). This model provides a sensitive method for detecting many strong contact sensitisers as well as some moderate and weak ones and produces an immunological response that is representative of contact allergy in man.
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The test was carried out in-house in 1987, before the LLNA method had been validated
- Specific details on test material used for the study:
- Batch No: JMR/2592/1
- Details on the study design:
- Not relevant
- Details on the study design:
- Not relevant
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Each group consisted of five male and five female Dunkin Hartley derived guinea pigs (Porcellus Animal Breeding Ltd.). Positive control (benzylpenicillin, BPEN) and untreated control groups were also included.
No details on environmental conditions have been provided in the study report. - Route:
- epicutaneous, open
- Vehicle:
- other: Materials were dissolved in ECT (96% ethanol/methyl cellosolve/Tween 80, 45:45:10 parts per volume)
- Concentration / amount:
- Concentration of vehicle: ECT (96% ethanol/methyl cellosolve/Tween 80, 45:45:10 parts by volume).
Concentration of test material:
In a preliminary irritancy titration 10%, 5%, 2.5% and 1% w/v solutions of the test material were applied to the skin of untreated guinea pigs. A 10% w/v solution of the test material was used for induction and a 5% w/v solution for challenge. BPEN was used as a 5% w/v solution for positive control of both induction and challenge. - Day(s)/duration:
- 16 days for hypersensitivity
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: Materials were dissolved in ECT (96% ethanol/methyl cellosolve/Tween 80, 45:45:10 parts per volume)
- Concentration / amount:
- 5% w/v solution of test material
- Day(s)/duration:
- approximately 2 days after challenge (on the 29th day of the study)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5/sex/group
- Details on study design:
- Each group consisted of five male and five female Dunkin-Hartley derived quinea pigs (Porcellus Animal Breeding Ltd.). Positive control (benzyl penicillin, BPEN) and untreated control groups were also included. Treatment consisted of six epicutaneous applications of the test (0.05 ml) and control materials on days 1, 3, 5, 8, 10 and 12 of the study using the same skin site for each application (induction procedure). After allowing 16 days for hypersensitivity to develop, the animals were challenged on day 29 for contact sensitivity.
- Challenge controls:
- On day 29 of the study the animals in the GR46580X group were challenged by topical application of 0.05 ml of a 5% w/v solution of GR46580X and ECT to separate sites on the closely clipped flanks. The positive control group was similarly challenged with 0.05 ml of BPEN solution and ECT. The untreated group received all the challenge materials, 0.05 ml per site. The challenge materials were systematically rotated between challenge sites within each treatment group.
- Positive control substance(s):
- yes
- Remarks:
- benzyl penicillin (BPEN) was used as a 5% w/v solution for positive control of both induction and challenge.
- Positive control results:
- The positive control material was strongly sensitising : 9/10 animals showed positive reactions to challenge at the 24 hour reading and 10/10 at the 48 hour reading
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05 ml of 5% w/v solution of test material in ECT
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05 ml of 5% w/v solution of test material in ECT
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05 ml of 5% w/v solution of test material in ECT
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% w/v
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% w/v
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Read-across from Thioacid:
GR46580X is considered to be a strong sensitiser - Executive summary:
Read-across from Thioacid:
GR46580X was tested for potential contact allergenicity by repeated dermal applications of a 10% w/v solution in 96% ethanol/methyl cellosolve/Tween 80, 45:45:10 parts per volume. 9/10 animals responded positively to challenge with a 5% w/v solution of the test material. In the test system used GR46580X was strongly skin sensitising. Appropriate precautions should be taken to avoid exposure to this compound.
Reference
Animal number 61350 (group 1, untreated) showed scouring on day 9 and died later on the same day. Animal numbers 61369 (group 2, GR46580X), 61354 (group 2) and 61368 (group 2) showed scouring on days 5, 18, and 29 respectively. The remaining animals showed no general loss in condition and there were no significant differences in body weights..
8/10 animals in the GR46580X treated group showed positive reactions to challenge at the 24 hour reading and 9/10 at the 48 hour reading. The positive control material, BPEN, was strongly sensitising: 9/10 animals showed positive reactions to challenge at the 24 hour reading and 10/10 at the 48 hour reading. One (1/9) animal in the untreated control group showed reactions to BPEN and ECT at the 48 hour reading.
There were no significant differences in body weights.
Please see attached 'Skin sensitisation tables' for summary skin sensitisation results and animal body weight changes.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Justification for classification or non-classification
A study on female and male guinea pigs showed strong skin sensitising properties for thioacid. Skin sensitisation results for the substance are sufficient to classify it as Skin Sensitiser 1.
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.
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