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EC number: 217-588-1 | CAS number: 1897-45-6
- 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:
- weight of evidence
- Study period:
- 30 Mar 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The challenge concentration was inadequate for elicitation of sensitisation and insufficient volume of the material was used on each test site during the irritancy and inductions phases so that the skin at the site was not entirely covered.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The GPMT test has been carried out as an animal test to predict human sensitisation for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- Chlorothalonil
- EC Number:
- 217-588-1
- EC Name:
- Chlorothalonil
- Cas Number:
- 1897-45-6
- Molecular formula:
- C8Cl4N2
- IUPAC Name:
- tetrachlorobenzene-1,3-dicarbonitrile
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: approximately 350 g
- Housing: housed individually in appropriately-sized cages
- Diet: guinea pig chow, ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 23
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: acetone
- Concentration / amount:
- Injection: 0.1 mL
Treatment: adjuvant (FCA) diluted equally with acetone - Day(s)/duration:
- Day 0: First injection of the three pairs of intradermal injections
- Route:
- intradermal
- Vehicle:
- other: acetone
- Concentration / amount:
- Injection: 0.1 mL
Treatment: 0.5 % test substance (w/v) in a 50:50 mixture of FCA and acetone - Day(s)/duration:
- Day 0: Second injection of three pairs of intradermal injections
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: acetone
- Concentration / amount:
- Injection: 0.1 mL
Treatment: 0.5 % test substance (w/v) in acetone - Day(s)/duration:
- Day 0: Third injection of the three pairs of intradermal injections
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: acetone
- Remarks:
- control group
- Concentration / amount:
- Injection: 0.1 mL
Treatment: FCA diluted equally with acetone - Day(s)/duration:
- Day 0: First control injection out of three pairs of injections
- Route:
- intradermal
- Vehicle:
- other: acetone
- Remarks:
- control group
- Concentration / amount:
- Injection: 0.1 mL
Treatment: FCA diluted equally with acetone - Day(s)/duration:
- Day 0: Second control injection out of three pairs of injections
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- control group
- Concentration / amount:
- Injection: 0.1 mL
Treatment: Acetone - Day(s)/duration:
- Day 0: Third control injection out of three pairs of intradermal injections
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Volume/area: 0.1 mL/2 x 4 cm area over the site of injection
Treatment: 1 % test substance in acetone, occlusive - Day(s)/duration:
- Day 7: all test animals for 48 h
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Volume/area: 0.1 mL/2 x 4 cm area over the injection site
Treatment: Acetone; occlusive - Day(s)/duration:
- Day 7: all control animals for 48 h
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Volume/area: 0.05 mL/2 x 2 cm area on one flank of each guinea pig in the test and control groups
Treatment: 0.001 % test substance in acetone - Day(s)/duration:
- Day 21: occlusive dressing for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Volume: 0.75 mL
Treatment: 0.001 % test substance in acetone - Day(s)/duration:
- 48 h, occlusive
- Adequacy of challenge:
- other: Re-challenge done due to the wrong interpretation of irritation study
- No. of animals per dose:
- 5 animals per sex per dose
- Details on study design:
- RANGE FINDING TEST/IRRITATION STUDY:
For irritation testing, four 2 x 2 cm sites (2 on each flank) were designated on each of 2 male and 2 female guinea pigs. A volume of 0.05 mL of each of 4 different concentrations of test substance in acetone (i.e. 0.5%, 0.01%, 0.005% and 0.001% (w/v) was applied to the 4 sites on each animal). The sequence of the 4 concentrations of test material was varied from animal to animal to minimize the bias associated with the location of application, e.g. skin thickness. After treatment, the application sites were covered with gauze, then with occlusive plastic dressings and, finally, elastoplast tape.
After 24 hours of occlusion, the coverings were removed and irritation at each application site was determined. The highest concentration of the test substance in acetone causing no erythema or oedema at the site of application on any of the 4 animals was considered to be the highest non-irritating concentration. - Challenge controls:
- 0.05 mL of acetone alone
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.001 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Grade 2
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: 2nd challenge
- Remarks:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.001%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: 2nd challenge
- Remarks:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The irritancy phase was repeated on all 24 guinea pigs. This testing was performed to give a guide in subsequent studies for determining irritancy levels. The following concentrations of the test substance were applied: 0.5%; 0.01%; 0.005%; and 0.001%. The volume was changed from 0.05 mL to 0.075 mL. An occlusive bandage covered the sites for 24 hours. The sites were graded 24 and 48 hours after the bandages were removed.
The 0.001% concentration of the test substance in acetone was the only concentration not to cause irritation on the test and control groups of animals. However, these animals had previously been exposed to acetone, test substance and FCA, which would tend to make them more reactive. Various difficulties encountered during the study made the results impossible to definitively interpret. The major problems were that 0.001% test substance was too low a concentration to have been applied in the challenge phase; the highest non-irritating concentration was probably nearer 0.005% or higher. The volume applied was also too low, and therefore the site was not adequately covered with solution. The volume which will cover the site is 0.075 mL.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The first challenge with 0.001% test substance yielded a skin reaction in one animal, however due to technical problems encountered during the study, the results are inconclusive.
- Executive summary:
The objective of the Guinea Pig Maximization Test (OECD 406, under GLP) was to evaluate the sensitisation potential of the test substance under exaggerated exposure conditions. In order to determine the lowest non-irritant concentration, 4 animals were exposed to 0.5%, 0.01%, 0.005%, and 0.001% (w/v) test substance in acetone. After 24 hours of occlusion, the coverings were removed and irritation at each application site was determined. The highest concentration of the test substance in acetone causing no erythema or oedema at the site of application on any of the 4 animals was considered to be the highest non-irritating concentration. Next, 20 animals (2 groups of 5 females and 5 males) were injected intradermally with 0.5% test substance in acetone with or without FCA (test group), FCA in acetone (test group and control group) or acetone alone (control group). After 7 days both groups were re-induced with topical, occlusive administration of 1% test substance in acetone or acetone alone (control group). Next, the animals were challenged (day 21) with 0.001% test substance.
The results were inconclusive, due to problems which occurred in this study. There were two major problems which occurred during the study. The primary difficulty was a challenge concentration of the test substance that was inadequate for elicitation of sensitisation. The second problem was that insufficient volume of the material was used on each test site during the irritancy and inductions phases of testing, so that the skin at the site was not entirely covered. This led to uneven concentrations in the patch test area and spurious results. A further study is needed to evaluate the sensitisation potential of this compound using the Guinea Pig Maximization test method.
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