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EC number: 203-425-1 | CAS number: 106-70-7
- 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:
- key study
- Study period:
- 22 Apr - 04 June 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study. Reliability check data were not reported in details, but a report number was mentioned referring to these data. Since the study was GLP and guideline conform, the non-reporting of the reliability check data was not considered to affect the validity and reliability of the present study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was performed in 1992 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".
Test material
- Reference substance name:
- Methyl hexanoate
- EC Number:
- 203-425-1
- EC Name:
- Methyl hexanoate
- Cas Number:
- 106-70-7
- Molecular formula:
- C7H14O2
- IUPAC Name:
- methyl hexanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl hexanoate
- Batch No.: 1291191
- Physical state: colourless liquid
- Purity: > 98%
- Stability: stable for at least 3 years
- Expiration date: June 24, 1994
- Storage: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain as given in study report: Dunkin-Hartley; Crl: (HA)BR
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: approx. 335 g
- Housing: 2-3 animals in Makrolon Type IV cages with standard softwood bedding
- Diet: Pelleted Altromin Maintenance Diet 3022 (Altromin, Lage, Germany), ad libitum, and carrots offered regularly
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction: 90% test substance in olive oil
Challenge: 50% test substance in olive oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction: 90% test substance in olive oil
Challenge: 50% test substance in olive oil
- No. of animals per dose:
- 3 (preliminary test), 10 (main test, both control and treatment)
- Details on study design:
- RANGE FINDING TESTS:
In a preliminary study a 90% dilution of the test substance in olive oil was detected as minimal irritating and a 50% dilution as a maximally non-irritating concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (once a week)
- Exposure period: 6 h
- Test groups: 10 animals treated with the test substance
- Control group: 10 animals treated with olive oil alone
- Site: left cranial flank
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 90% solution in olive oil
A patch test chamber (1 cm², van der Bend, INTERDERM bv) was used. The application dose was 0.08 mL/chamber
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the 3rd induction
- Exposure period: 6 h
- Test groups: 10 animals treated with the test substance
- Control group: 10 animals treated with the test substance
- Site: bilaterally to caudal sheared flanks
- Concentrations: 50% solution in olive oil
- Evaluation (hr after challenge):24 and 48 h
SCORING OF SKIN REACTION
Grades of skin reaction:
0 = no reaction;
1 = weak erythema and/or edema;
2 = moderate and diffuse erythema and/or edema;
3 = strong erythema and/or edema.
EVALUATION CRITERIA
At least 15 % of treated animals with dermal effects. - Positive control substance(s):
- yes
- Remarks:
- it was stated that last reliability check in the testing facility was done in May 1990 (Rep. Nr. given as TBD 900384)
Results and discussion
- Positive control results:
- Reliability check data not reported in present study report.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% solution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- weak dermal effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% solution. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% solution
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- weak dermal effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% solution. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% solution
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- weak dermal effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% solution. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% solution
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- weak dermal effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% solution. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects.
Any other information on results incl. tables
In the tabulation above only results from the right flank are given, as the right flank was not used for induction.
According to OECD guideline 406, challenge should be performed on the untreated flank of the animals.
Table 1: Skin reactions 24 and 48 h after challenge with 50% solution of methyl hexanoate in olive oil:
|
24 h |
48 h |
||||||
test group |
control (10) |
treatment (10) |
control (10) |
treatment (10) |
||||
flank |
left |
right |
left |
right |
left |
right |
left |
right |
no skin reaction |
1 |
7 |
4 |
9 |
3 |
7 |
6 |
7 |
weak |
9 |
3 |
6 |
1 |
7 |
3 |
4 |
3 |
moderate |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
strong |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
No deaths occurred. No significant differences in body weight gain were noticed between treatment and control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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