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EC number: 246-896-9 | CAS number: 25360-10-5
- 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:
- 1994-12-08 to 1995-01-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it adheres to OECD Guideline 406 recommendations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,1-dimethylheptanethiol (CAS # 25360-10-5)
- IUPAC Name:
- 1,1-dimethylheptanethiol (CAS # 25360-10-5)
- Details on test material:
- - Name of test material (as cited in study report): t-nonyl mercaptan
- Substance type: Heavy Mercaptan
- Physical state: Liquid
- Analytical purity: 99%
- Lot/batch No.: 94-000606
- Storage condition of test material: At room temperature protected from light
- Other: colourless liquid
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
- Source: Centre d'Elevage Lebeau, Gambais, France
- Age at study initiation: not reported
- Weight at study initiation: Male - 329 ± 25 grams; Females - 342 ± 14 grams
- Housing: Individually in polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 30% to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 1994-12-08 To: 1995-01-09
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- Preliminary study: Intradermal route - 0.1, 1, and 5% (w/w); Cutaneous route - 75% and 100% (w/w)
Main study: Induction phase - 1% (w/w); Challenge phase - 75% (w/w)
Challengeopen allclose all
- Route:
- other: cutaneous and occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Preliminary study: Intradermal route - 0.1, 1, and 5% (w/w); Cutaneous route - 75% and 100% (w/w)
Main study: Induction phase - 1% (w/w); Challenge phase - 75% (w/w)
- No. of animals per dose:
- Control group - 5 animals/sex/dose
Treatment group - 10 animals/sex/dose - Details on study design:
- RANGE FINDING TESTS:
Intradermal route - 24 hours before treatment, the dorsal region of the animals was clipped and the test substance was prepared in an appropriate vehicle. Intradermal administration of the test substance (volume 0.1 ml) at increasing concentrations (0.1%, 1% and 5% (w/w/)) was then performed in order to determine the minimum concentration which causes an irritation. Evaluation of the potential cutaneous reactions was conducted 24 and 48 hours after injection.
Cutaneous route - 24 hours before treatment, the dorsal region of the animals was clipped and the test substance was prepared in an appropriate vehicle (if necessary). 0.5 ml of each concentration (75% and 100% (w/w)) was applied to a dry gauze pad of approximately 4 cm2 and then held in place by an occlusive dressing for 24 hours. Potential cutaneous reactions were subsequently evaluated 24 and 48 hours after removal of the gauze pads.
MAIN STUDY
A. INDUCTION EXPOSURE - Intradermal Route
- No. of exposures: 1
- Exposure period: 7 days
- Test groups: FCA diluted with 0.9% NaCl (50% v/v); TS (1% w/w) in paraffin oil; Mixture of FCA diluted with 0.9% NaCl (50% v/v) and TS (1% w/w) in paraffin oil
- Control group: FCA diluted with 0.9% NaCl (50% v/v); Vehicle (Paraffin oil); Mixture of FCA diluted with 0.9% NaCl (50% v/v) and paraffin oil
- Site: Scapular area - both flanks (4 cm x 2 cm)
- Frequency of applications: 1
- Duration: 0-6 d
- Concentrations: same throughout
B . INDUCTION EXPOSURE - Cutaneous Route
- No. of exposures: 6
- Exposure period: 48 hours
- Test groups: 0.5 mL of TS in original form
- Control group: 0.5 mL of paraffin oil
- Site: Scapular area - both flanks (4 cm x 2 cm)
- Frequency of applications: 1
- Duration: 7-8 d
- Concentrations: same throughout
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 22-23 d
- Test groups: TS (75% w/w) in paraffin oil
- Control group: 0.5 mL Paraffin oil
- Site: TS - RF; Control - LF
- Concentrations: same throughout
- Evaluation (hr after challenge): 24 hrs - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Results and discussion
- Positive control results:
- At a concentration of 1% (w/w) 2,4 DNCB induced positive skin sensitization reactions in 95% of the guinea-pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema or oedema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No erythema or oedema observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% w/w
- No. with + reactions:
- 7
- Total no. in group:
- 19
- Clinical observations:
- No to well defined erythema observed in 7 of 19 animals (one animal was found dead but this was not considered treatment-related)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% w/w. No with. + reactions: 7.0. Total no. in groups: 19.0. Clinical observations: No to well defined erythema observed in 7 of 19 animals (one animal was found dead but this was not considered treatment-related).
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% w/w
- No. with + reactions:
- 4
- Total no. in group:
- 19
- Clinical observations:
- Very slight erythema observed in 4 of 19 of animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% w/w. No with. + reactions: 4.0. Total no. in groups: 19.0. Clinical observations: Very slight erythema observed in 4 of 19 of animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% w/w
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Very slight to severe erythema and no to slight oedema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1% w/w. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Very slight to severe erythema and no to slight oedema observed.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% w/w
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Very slight to severe erythema and no to slight oedema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% w/w. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Very slight to severe erythema and no to slight oedema observed.
Any other information on results incl. tables
Challenge Application:
Groups |
Sex |
Erythema Score |
Scoring of the cutaneous parameters |
|||
24 hours |
48 hours |
|||||
LF |
RF |
LF |
RF |
|||
Control 1 |
Male |
0 |
5/5 |
5/5 |
4/4 |
4/4 |
Treated 2 |
Male |
0 |
9/9 |
4/9 |
9/9 |
6/9 |
|
1 |
- |
4/9 |
- |
2/9 |
|
2 |
- |
1/9 |
- |
1/9 |
||
Control 1 |
Female |
0 |
5/5 |
5/5 |
5/5 |
5/5 |
Treated 2 |
Female |
0 |
10/10 |
8/10 |
10/10 |
9/10 |
|
1 |
- |
1/10 |
- |
1/10 |
|
2 |
- |
1/10 |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: weak sensitiser (Not classified)
- Conclusions:
- According to the maximisation method established by Magnusson and Kligman, cutaneous reactions attributable to the sensitisation potential of the test substance, 1,1-dimethylheptanethiol, at the concentration of 75% (w/w) were observed in 10% of the guinea-pigs. 1,1-dimethylheptanethiol was considered to be a weak sensitiser.
- Executive summary:
In a dermal sensitisation study, the skin sensitising potential of 1,1-dimethylheptanethiol was evaluated using Dunkin-Hartley guinea-pigs (5/sex – control; 10/sex - treatment) using the method of Magnusson and Kligman. The sensitisation potential of the test substance was evaluated after a 10-day induction period during which time the animals were treated with paraffin oil (control group) or the test substance (treated group). On day 1, in presence of Freund's complete adjuvant, 0.1 ml of the test substance at a concentration of 1% (w/w) in the vehicle was administered by intradermal route. On day 8, 0.5 ml of the test substance in its original form was applied by cutaneous route during 48 hours by means of an occlusive dressing. After a period of 12 days without treatment, a challenge cutaneous application of 0.5 ml of the vehicle (left flank) and 0.5 ml of the test substance at a concentration of 75% (wlw) in the vehicle (right flank) were administered to all animals. The test substance and the vehicle were prepared on a dry gauze pad then applied to the skin and held in place for 24 hours by means of an occlusive dressing. Cutaneous reactions on the challenge application sites were then evaluated 24 and 48 hours after removal of the dressing. After the final scoring period, the animals were killed and cutaneous samples were taken from the challenge application sites from the animals. The sensitivity of the guinea-pigs in C.I.T. experimental conditions were checked in a recent study with a positive sensitiser: 2,4-dinitrochlorobenzene. During induction period the test substance was applied at 0.1% (day 1) and 5% (day 8) concentrations. At cutaneous challenge application, 1% (w/w) was tested on the right flank.
No treatment-related clinical signs or deaths were noted during the study. Well-defined erythema was observed in 2/19 animals 24 and 48 hours after removal of the dressing. No effects of the treatment were noted in the control group. The guinea-pigs which were used in a recent study showed a satisfactory sensitisation response in 95% animals using a positive sensitizer (2,4-DNCB).
1,1-dimethylheptanethiol was considered to be weakly sensitising to the skin of guinea pigs.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it adheres to OECD Guideline 406 recommendations.
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