Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-894-2 | CAS number: 111-67-1
- 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:
- 1982-03-02 to 1982-05-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because although the study does not meet current OECD 406 guidelines, the study was well conducted and reported.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The induction dose was low and did not produce mild irritation
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in accordance with OECD and EU test guidelines applicable at the time of undertaking.
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 111-66-0
- Molecular formula:
- C8H16
- Details on test material:
- - Name of test material (as cited in study report): NEODENE-8
- Substance type: C8 alpha olefin
- Physical state: Clear liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Weight at study initiation: Average female-445 grams; Average male-518 grams
- Housing: Stainless steel caging-5 animals/cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 21.1
- Humidity (%): 40 to 70
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.5 millilitres of 1% W/V in absolute ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.5 millilitres of 1% W/V in absolute ethanol
- No. of animals per dose:
- 10 animals; 5 males, 5 females
- Details on study design:
- RANGE FINDING TESTS: Preliminary tests used 6 animals at three different concentrations (one male, one female animal were used at each concentration) to determine the highest concentration at which no irritation occurs. Each animal was treated at two sites. Preliminary test concentrations were 100, 50 and 1% W/V of Neodene-8 Alpha Olefin.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours/application
- Test groups: 10:5 males and 5 females
- Control group: 10: 5 males and 5 females
- Site: back/trunk region
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 0.5ml of 1% Neodene-8 in absolute ethanol
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Week 5 post induction
- Exposure period: 6 hours
- Test groups: 10: 5 males, 5 females
- Control group: 10: 5 males, 5 females
- Site: back/trunk region; one patch placed at the original treated site; another patch placed at a virgin site posterior to the original patch
- Concentrations: 0.5ml of 1% Neodene-8 in absolute ethanol
- Evaluation (hr after challenge): 24 and 48 hours post exposure
OTHER: In addition to the three groups used in the main study (Induction Exposure and Challenge Exposure), a fourth group termed "Irritation Control Group" was treated during the fifth week only along with the Challenge Group to determine the test materials sensitisation potential - Challenge controls:
- Control group consisted of 10 animals (5 males; 5 females) treated with 0.5 millilitres of absolute ethanol.
- Positive control substance(s):
- yes
- Remarks:
- 0.5ml of 0.1% W/V 2,4-dinitrochlorobenzene in diethyl ether
Results and discussion
- Positive control results:
- The positive control, 2,4-dinitrochlorobenzene, was found to be irritating (average score at week 1 was 2.00 and at week 5 was 1.78). Eschar and necrosis were evident in the positive control on both the treatment site and challenge site indicating a positive skin sensitising reaction.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 05ml of 1% W/V
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 05ml of 1% W/V. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5ml of 1% W/V
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5ml of 1% W/V. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- other: scores for the vehicle control group were not provided. Control group showed little or no increase in skin irritation
- Reading:
- 2nd reading
- Group:
- positive control
- Clinical observations:
- Eschar and necrosis were evident in the positive control on both the treatment site and challenge site indicating a positive skin sensitising reaction.
- Remarks on result:
- other: The positive control, 2,4-dinitrochlorobenzene, was found to be irritating (average score at week 1 was 2.00 and at week 5 was 1.78).
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- Neodene-8 Alpha Olefin is not sensitising when applied dermally to albino Hartley guinea pigs.
- Executive summary:
Hartley albino guinea pigs were used in this study to determine the skin sensitisation potential of Neodene-8 Alpha Olefin. Prior to main study initiation, a preliminary test was conducted during week three of the pre-trial period using 6 animals at three different concentrations (1 male, 1 female at each concentration) to determine the highest concentration at which no irritation occurs. Each animal was tested at two sites. Preliminary testing included 0.5ml of 100, 50, and 1% W/V Neodene-8 in absolute ethanol. Results of this preliminary test indicated that no irritation was present at the 1% W/V concentration while slight irritation occurred at the two higher concentrations. Hence the 1% W/V concentration was used to conduct the main sensitisation study.
Two days prior to main study initiation, the animals were examined for general health and suitability for testing. Animals certified to be healthy were weighed and randomly assigned to four treatment groups: vehicle control, positive control, test group and irritation control. Each treatment group consisted of 5 male and 5 female animals. Approximately 48 hours prior to each dose application, the animals were clipped free of hair from the back/trunk region. Approximately 18 -24 hours prior to dosing, the animals were depilated with NEET hair removal lotion and rinsed with warm water and dried. Each sensitising treatment consisted of dispensing an appropriate dose on a 1" x1" gauze pad which was prepared by attaching the corners of the gauze pad to a strip of aluminium foil while using a minimum of Blenderm surgical tape. This patch was then applied to the anterior central portion of the clipped area. The aluminium foil dressing was kept in place at the treated site using strips of Blenderm tape and occluded with saran wrap. The animals were then placed in a stainless steel wire restrainer for six hours before removal of the patch and any excess test material using moistened gauze pads. This process was repeated for two additional weeks for a three week total exposure period.
The challenge application was conducted in a similar manner except that at the time of this application, one patch was placed at the original site, while another patch was placed at a virgin site immediately posterior to the original patch. The treatment period was the same, i.e. six hours of exposure during week 5 of the main study (animals were allowed a two week recovery period prior to challenge dose application).
In addition to the challenge group, the study authors also included an "Irritation Control Group" (5 males and 5 females) which was treated only once during week 5 with the application of only one patch. All treated animals were scored for skin reactions approximately 24 and 42 hours after each treatment using the following scoring system:
Scoring Scale
No Reaction
0
Minimal erythema (barely perceptible with edges not defined)
+
Slight erythema (pale red/pink in colour and edges of area defined)
1
Moderate erythema (red in colour and edges well-defined)
2
Moderate erythema with slight oedema (red in colour, edges well-defined, raised less than 1millimetre)
3
Severe erythema with moderate oedema and cracking of skin (beet/crimson red in colour, raised 1 mm or more, cracking of skin)
4
All treated animals were scored for skin sensitisation approximately 24 and 48 hrs post exposure. The study authors reported that there were no changes in body weight during the course of the study and concluded that Neodene-8 Alpha Olefin treated group and the control group showed little or no increase in skin irritation. The positive control group performed as expected with treated animals exhibiting Eschar and necrosis on both the treatment site and challenge site indicating a positive skin sensitising reaction. Based on these results, the study authors concluded that Neodene-8 Alpha Olefin is not sensitising to albino Hartley guinea pigs when applied dermally.
This study was given a Klimisch score of 1 andis classified as reliable without restrictions because it closely followed OECD 406 guidelines and was GLP compliant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.