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EC number: 218-080-2 | CAS number: 2050-08-0
- 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
- Study period:
- 11.06.80- 12.11.81
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards and acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Magnusson, B. and Kligman, A.M. 1970. Allergic Contact Dermatitis in the Guinea Pig: Identification of Contact Allergens. C.C. Thomas, Springfield, Illinois, U.S.A
- Principles of method if other than guideline:
- Sensitisation was induced in guinea pigs by intradermal injections of both test substance and Complete Freunds Adjuvant and the induction process supplemented 7 days later by test substance applied to the shoulder injection sites under occluded patch: further challenges were made at weekly intervals as required.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA not available at time of testing
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): amyl salicylate
- Structural formula attached as image file (if other than submission substance): see Fig. - Species:
- guinea pig
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Environmental Safety Division
- Weight at study initiation: approximately 344 g- 364 g
- Water (e.g. ad libitum): ad libitum - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Injection induction: 0.01 % dobs/ saline. Application induction and application challenge: acetone.
- Concentration / amount:
- Induction (intradermal injection): 1%
Induction (covered patch application): 40%
challenge (covered patch application): 10% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Injection induction: 0.01 % dobs/ saline. Application induction and application challenge: acetone.
- Concentration / amount:
- Induction (intradermal injection): 1%
Induction (covered patch application): 40%
challenge (covered patch application): 10% - No. of animals per dose:
- 6 males and 4 females
- Details on study design:
- RANGE FINDING TESTS: Animals were treated by intradermal injections in the shoulder region to induce sensitisation and 7 days later the sensitisation was boosted by an occluded patch placed over the injection site. Fourteen days later the animals were challenged on 1 flank by occluded patch. Seven days after this a further confirmatory challenge was given on the opposite flank using the same method.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intradermal injection followed 1 week later by topical application
- Exposure period: topical application 48 hrs
- Test groups: 1
- Control group: 2 types of control groups are used. Treated controls: 4 animals of the same sex are selected and treated controls for the first challenge. They are given a mock induction treatment at the same time and in the same way as for the test animals except that test substance is omitted from the injection and application preparations. Untreated control: 4 previously untreated animals of the same sex and weighing approximately the same as the test animals.
- Site: 2x4 cm are in the dorsal shoulder region.
- Frequency of applications: Intradermal injection: 3 pairs of intradermal injections are made within the site as follows (i) two 0.1 mL injections of 50 % Freund's complete adjuvant (FCA) in the solvent chosen for the test substance. (ii) two 0.1 mL injections of test substance at the concentration selected for the induction from the preliminary irritation test. (iii) two 0.1 mL injections of the test substance in solvent mixed 50/50 with FCA such that the final concentration of test substance injected is the same as that in (ii). Topical application: 1 week after the injections the same 2x4 cm area was clipped and shaved. A 2x4 cm filter paper patch attached by double-sided adhesive tape to a 4x6 cm piece of thin polythene was saturated with test substance and placed over the shaved site. The patch was held in place by adhexive plaster wrapped around the trunk behind the forelimbs.
- Duration: 13 to 14 days
- Concentrations: intradermal injection 1 %, covered patch application 40 %
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge:
- Exposure period: 24 hrs
- Test groups: 1
- Control group: Treated controls: At first challenge they are treated in exactly the same way as the test animals. Untreated controls: At every challenge in the test are treated in exactly the same way as the test animals.
- Site: flank. For each animal, an 8 mm diameter filter paper patch in am 11 mm aluminium patch test cup was saturated with the test substance at the selected challenge concentration and applied to the site. The patch was held in place by adhesive plaster wound around the trunk.
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48 hrs - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 4 animals were noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 4 animals were noted to have barely perceptible erythema..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 animal was noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 animal was noted to have barely perceptible erythema..
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 animal was noted to have spots of erythema.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 1 animal was noted to have spots of erythema..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Treated controls
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 3 animals were noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Treated controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 3 animals were noted to have barely perceptible erythema..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: Treated control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 2 animals were noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Treated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 2 animals were noted to have barely perceptible erythema..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Untreated control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal was noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Untreated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal was noted to have barely perceptible erythema..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: Untreated control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal was noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: Untreated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal was noted to have barely perceptible erythema..
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- other: Untreated control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- 1 animal was noted to have barely perceptible erythema.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: other: Untreated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal was noted to have barely perceptible erythema..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Untreated control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Untreated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 24
- Group:
- other: Untreated controls
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: other: Untreated controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: Challenge 3
- Hours after challenge:
- 48
- Group:
- other: Untreated control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: other: Untreated control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was assessed for skin sensitisation according to the method described in Magnusson and Kligman (1970). Sensitisation was induced in guinea pigs by intradermal injections and supplemented 7 days later by an occluded patch. Three challenges were then given by occluded patch. None of the animals sensitised after 3 challenges and so the test substance is not considered to be a sensitiser by this method.
- Executive summary:
Male and female Dunkin-Hartley guinea pigs were purchased from Environmental Safety Division. A preliminary, dose range-finding study was conducted on 4 male guinea pigs weighing 360 g- 428 g with the test substance being administered via intradermal injection. A preliminary, dose range-finding study was conducted on 4 male guinea pigs weighing 454 g- 546 g with the test substance being administered via an occluded patch.
The main study was conducted using 1 group of 10 guinea pigs, composed of 6 males and 4 females. Sensitisation was induced by intradermal injections and supplemented 7 days later by an occluded patch at dose levels 1 % and 40 % respectively. Three challenges were then given by occluded patch at the dose level 10 %. None of the animals sensitised after 3 challenges and so the test substance is not considered to be a sensitiser by this method.
All animals were observed at 24 and 48 hours after each challenge; reactions were noted.
There were no positive results for sensitization after 3 challenges. Four animals were noted to have barely perceptible erythema at 24 hours after the first challenge. One animal was noted to have barely perceptible erythema at 48 hours after the first challenge. One animal was noted to have barely perceptible erythema at 24 hours after the second challenge.
None of the animals sensitised after 3 challenges and so the test substance is not considered to be a sensitiser by this method.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A Magnusson and Kligman maximisation study in the guinea pig was conducted. The study has been scored a klimisch rating of 2.
Male and female Dunkin-Hartley guinea pigs were purchased from Environmental Safety Division. A preliminary, dose range-finding study was conducted on 4 male guinea pigs weighing 360 g- 428 g with the test substance being administered via intradermal injection. A preliminary, dose range-finding study was conducted on 4 male guinea pigs weighing 454 g- 546 g with the test substance being administered via an occluded patch.
The main study was conducted using 1 group of 10 guinea pigs, composed of 6 males and 4 females. Sensitisation was induced by intradermal injections and supplemented 7 days later by an occluded patch at dose levels 1 % and 40 % respectively. Three challenges were then given by occluded patch at the dose level 10 %. None of the animals sensitised after 3 challenges and so the test substance is not considered to be a sensitiser by this method.
All animals were observed at 24 and 48 hours after each challenge; reactions were noted.
There were no positive results for sensitization after 3 challenges. Four animals were noted to have barely perceptible erythema at 24 hours after the first challenge. One animal was noted to have barely perceptible erythema at 48 hours after the first challenge. One animal was noted to have barely perceptible erythema at 24 hours after the second challenge.
None of the animals sensitised after 3 challenges and so the test substance is not considered to be a sensitiser by this method.
Migrated from Short description of key information:
M&K Guinea pig study (K2): Not sensitising
Justification for selection of skin sensitisation endpoint:
The test substance was assessed for skin sensitisation according to the method described in Magnusson and Kligman (1970). Sensitisation was induced in guinea pigs by intradermal injections and supplemented 7 days later by an occluded patch. Three challenges were then given by occluded patch. None of the animals sensitised after 3 challenges and so the test substance is not considered to be a sensitiser by this method.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
No data available.
Justification for classification or non-classification
The substance did not induce a sensitisation reaction in a guinea pig maximisation test conducted on the registration substance. Therefore classification in accordance with Regulation (EC) No. 1272/2008 (CLP) or in accordance with Regulation 67/548/EEC. is not required.
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