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EC number: 205-003-2 | CAS number: 130-95-0
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is done similar to OECD guideline 406.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Guinea pig maximisation test as described by Magnusson Kligman (1969, 1970) was used, under the same conditions as reported earlier (Wahlberg Boman, 1978)
- Principles of method if other than guideline:
- Guinea pig maximisation test as described by Magnusson Kligman (1969, 1970) was used. At intradermal induction 0.25 % of the drug in distilled water was used. At epicutaneous induction 20 % of the drug in petrolatum was used with previous SLS treatment. Challenge is by topical application. Provided there is no irritation. Challenge testing was performed on day 21 with 1, 5, and 10 % of the drugs in petrolatum. The chambers were left on the animals for 24 h. The challenge site is evaluated 24 hours and 48 hours after removal of the patch. The statistical method was chi-squared analysis.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Reference to existing guideline study (guinea pig maximization test). Additional animal testing is not considered necessary.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water and petrolatum
- Concentration / amount:
- intradermal induction: 0.25 % of the drugs in distilled water, epicutaneous induction: 25 % of the drugs in petrolatumChallenge testing was performed on day 21 with 1, 5 and 10 % of the drugs in petrolatum.
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water and petrolatum
- Concentration / amount:
- intradermal induction: 0.25 % of the drugs in distilled water, epicutaneous induction: 25 % of the drugs in petrolatumChallenge testing was performed on day 21 with 1, 5 and 10 % of the drugs in petrolatum.
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 1- Test groups: 20- Control group: 20- Concentrations: 0.25 % intradermal induction, 25 % epicutaneous inductionB. CHALLENGE EXPOSURE- No. of exposures: 1- Test groups: 20- Control group: 20- Day(s) of challenge: on day 21- Concentrations: 1 %, 5 % and 10 % of the drugs in petrolatum- Exposure period: 24h - other: readings were taken 24 and 48h after removal of the test chambers
- Challenge controls:
- 20 control animals which get 1 %, 5 % and 10 % of the drugs in petrolatum
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: no data.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Quinine hydrochloride is a potent contact allergen.
- Executive summary:
The contact sensitivity to quinine hydrochloride was experimentally determined in guinea-pigs. Quinine hydrochloride was found to be a grade V allergen according to Magnusson et al., 1969. 85 % and 95 % of the animals reacted to 5 % or 10 % of quinine hydrochloride, respectively and 25 % of the animals reacted to 1 % of quinine hydrochloride after 48 h. 80 % of the animals reacted to 10 % quinine hydrochloride and 85 % of the animals reacted to 5 % quinine hydrochloride after 24 h. 15 % of the animals reacted to 1 % quinine hydrochloride after 24 h. The control animals showed no reaction after 24 h and 48 h. Quinine hydrochloride is obviously a potent contact allergen and has to be classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The contact sensitivity to quinine hydrochloride was experimentally induced in guinea pigs. 95 % and 85 % of the animals reacted to 10 % or 5 % of quinine hydrochloride, respectively and 25 % of the animals reacted to 1 % of quinine hydrochloride after 48 h. 80 % of the animals reacted to 10 % quinine hydrochloride and 85 % of the animals reacted to 5 % quinine hydrochloride after 24 h. Only 15 % of the animals reacted to 1 % quinine hydrochloride after 24 h. The control animals showed no reaction after 24 h and 48 h. Quinine hydrochloride is obviously a potent contact allergen. Furthermore, it was shown in human that quinine is a contact allergen. Five patients were tested with a standard patch test and became sensitized after exposure.
Migrated from Short description of key information:
Quinine hydrochloride is obviously a potent contact allergen.
Justification for selection of skin sensitisation endpoint:
Study is done similar to OECD Guideline 406 on the read across substance quinine hydrochloride.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the guinea pig maximisation test, 95% of the animals reacted to 10 % of quinine hydrochloride after 48 h. According to CLP 1272/2008 regulation (Bühler Assay), more than 60 % of the animals reacted by a topical induction of > 0,2 % to ≤ 20 %. Therefore, quinine has to be classified category 1A (H317).
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