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EC number: 620-365-5 | CAS number: 9016-72-2
- 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
Based on a reliable study according to OECD 406 the test substance is considered to be a strong skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- GPMT
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986/04 to 1986/05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981 [GPMT]
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline (Acute Toxicity - Sensitisation of Skin, Amtsblatt der Europaeischen Gemeinschaften No. L 251/113-116 of 19.9.1984).
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo test was done before LLNA as first-choice method for in-vivo testing was set into force.
- Species:
- guinea pig
- Strain:
- other: SPF, DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- Body weight of the test animals: 312 - 379 g
Age: 5-7 weeks
Acclimatisation period: 8 days
Housing: The animals were kept, five to a Makrolon cage type IV, on lowdust wood granules.
Temperature: approx. 21° - 24° C
Humidity: approx. 30 % - 55 %
light/dark rhythm: twelve hours.
A forced ventilation system was installed - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% / 0.1 mL
- 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:
- 25% / 0.5 mL
- Day(s)/duration:
- 1 week after intradermal induction for 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- 3 weeks after intradermal induction / 24 hours
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 2.5% / 0.5 mL
- Day(s)/duration:
- 5 weeks after intradermal induction / 24 hours
- Adequacy of challenge:
- other: This concentration was chosen to establish whether the findings obtained after the first challenge were present at a much lower concentration.
- No. of animals per dose:
- Three groups (one test compound, propineb, and two control groups), test compound, propineb consisting of 20 males. Two control groups with 10 males/group
- Details on study design:
- Intradermal induction: An 0.1 % substance formulation was used, since this came closest to the degree of healing of the control in the pilot test. Starting at the back of the neck, three intra-dermal injections were given parallel on each side. The intervals between the injection sites were approx. 1 to 2 cm. The volume injected per site was 0.1 mL. The skin was shorn 24 hours before administration.
in the test group, the first injection site pair (cranial): Freund's complete adjuvant (Difco Lab.) diluted 1:1 with sterile physiological saline solution. The second injection site pair (medial): 0.1 % test substance, formulated in sterile physiological saline solution. The third injection site pair (caudal): 0.1 % test substance , formulated in sterile physiological saline solution and with Freund's complete adjuvant in equal parts.
In the control group, animals were treated in the same way as the test compound group, but the formulations for injection site pairs 2 and 3 did not contain any test compound. Topical induction occurred one week after intradermal induction. A 25 % formulation was used, since higher homogeneous concentrations could not be produced. Hypoallergenic dressings (2x4 cm) were placed between or on the injection sites, covered with aluminium foil, and fastened to the skin for 48 hours with Fermoflex adhesive tape.
The application sites were shorn and irritated with 10 % sodium lauryl sulphate, formulated in paraffin oil, 24 hours before application. The hypoallergenic dressings were treated or soaked with a volume of 0.5 mL as follows. The test compound group had 25 % test substance, formulated in sterile physiological saline solution. The control groups used a vehicle (sterile physiological saline solution).
- No. of exposures: 2
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: test compound in physiological saline
- Control group: physiological saline
- Site: left flank
- Concentrations: First challenge: 25%, second challenge: 2.5%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- A similar control dressing was applied to the right flank. This was soaked only with the vehicle (sterile physiological saline solution). The volume applied was 0.5 mL.
- Positive control substance(s):
- yes
- Remarks:
- 2% formaldehyde
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% intradermal induction, 25% 1. challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% intradermal induction, 25% 1. challenge
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% intradermal induction, 25% challenge
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- scores 1 to 3
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% intradermal induction, 25% challenge
- No. with + reactions:
- 19
- Total no. in group:
- 19
- Clinical observations:
- score 1 to 2 and scaly areas
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% intradermal induction, 2.5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- score 1
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% intradermal induction, 2.5% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% intradermal induction, 2.5% challenge
- No. with + reactions:
- 19
- Total no. in group:
- 19
- Clinical observations:
- mainly score 3 and encrustation in the treatment area
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% intradermal induction, 2.5%
- No. with + reactions:
- 19
- Total no. in group:
- 19
- Clinical observations:
- scores 1 to 3 and encrustrations in treatment area
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The registered substance was evaluated in a sensitization test (MAGNUSSON and KLIGMAN's maximisation test) for possible skin-sensitising potential for guinea pigs. The study conformed to the OECD Guideline for Testing of Chemicals "Skin Sensitisation" No. 406, adopted 12.5.1981, and the EC Guideline. The test compound was examined to see if it had any a skin-sensitising effect concentrations that were applied for the Intra-dermal induction: 0.1 %, for the topical induction: 25 %, for the first challenge: 25 % and for the second challenge: 2.5 % . The result of the second challenge confirmed that of the first, although the concentration used was lower by a factor of ten. A clear sensitising potential for guinea pigs was therefore noted for the test compound under the described test conditions.
- Executive summary:
The fungicidal, propineb was evaluated in a sensitisation test (MAGNUSSON and KLIGMAN's maximisation test) for possible skin sensitising potential for guinea pigs. The following concentrations were applied during the study. Intra-dermal induction: 0.1 %, Topical induction: 25 %, First challenge: 25 %, Second challenge: 2.5 %. After the first challenge (test compound concentration 25 %), twenty animals in the test compound group, which consisted of twenty animals, reacted positively, as against no positive reactions in the first control group, which consisted of ten animals. After the second challenge (test compound concentration 2.5 %), eighteen animals in the test compound group, which consisted of nineteen animals, reacted positively, as against four positive reactions in the second control group, which consisted of ten animals. The study therefore detected clear indications of the test compound's skin-allergenic potential for guinea pigs.
Reference
Autopsy findings
Abdominal cavity filled with much blood; liver very pale and coated with coagulated blood; kidneys and spleen pale; wall of forestomach torn.
Table one
First challenge of Positively reacting animals:
test compound group (20 animals) | 1st control group (10 animals) |
compound dressing | control dressing | compound dressing | control dressing |
20 | 0 | 0 | 0 |
Table two
Second challenge with Positively reacting animals
test compound group (19 animals) | 2nd control group (10 animals) |
compound dressing | control dressing | compound dressing | control dressing |
19 | 1 | 5 | 1 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A key skin sensitisation study according to OECD 406 and GLP is available (M-053641-01-1). The test substance was evaluated in a guinea pig maximisation test. The following concentrations were applied during the study. Intra-dermal induction: 0.1 %, Topical induction: 25 %, First challenge: 25 %, Second challenge: 2.5 %. After the first challenge (test compound concentration 25 %), twenty animals in the test compound group, which consisted of twenty animals, reacted positively, as against no positive reactions in the first control group, which consisted of ten animals. After the second challenge (test compound concentration 2.5 %), eighteen animals in the test compound group, which consisted of nineteen animals, reacted positively, as against four positive reactions in the second control group, which consisted of ten animals. A positive control study with 2% formaldehyde performed earlier showed clear positive effects, showing the validity of the test.
Based on the results of this study the test substance is considered to be a strong skin sensitiser.
In a supporting study (Bühler test) no skin sensitising potential was observed. However, no positive control was included which devalidates the study result.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation meet the criteria for classification according to Regulation (EC) 1272/2008, and the registered substance is therefore classified as Skin Sens. Category 1A (H317).
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