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EC number: 213-203-6 | CAS number: 929-59-9
- 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:
- Janury 21 1988 through February 20, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study have been performed before the REACh legislation enters into force.
Test material
- Reference substance name:
- 3,6-dioxaoctamethylenediamine
- EC Number:
- 213-203-6
- EC Name:
- 3,6-dioxaoctamethylenediamine
- Cas Number:
- 929-59-9
- Molecular formula:
- C6H16N2O2
- IUPAC Name:
- 2-[2-(2-aminoethoxy)ethoxy]ethan-1-amine
- Test material form:
- liquid
- Details on test material:
- - Physical state: liquid
- Appearance: colourless liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; 5601-49-1
STABILITY
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
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, Wilmington, Mass.
- Method and justofication for randomization: Treatement groups were housed by vertical cage positioning. Randomization was carried out by use of a random number table. One week before treatment commenced, all animals were weighrd, ranked according to body wight and assigned to treatment groups using a table of random numbers so that each treatemtn group ad a similar distribution according to the body weight. Animals beyond the extermes of the body weight range were not assigned to treatment groups. There were no statistically significant differences in mean body weights between any two groups of the same sex after allocation to the treatment groups.
- System of identification: Cages merked with animal number and dose level. Guinea pigs were ear tagged.
- Age at study initiation: no data
- Weight at study initiation: 300-500 grams
- Housing: Guine pigs were housed 2 per vage in 1/2 wire mesh cages. Size in accordance with "Guide for the care and use of Laboratory animals" of the Institut of Laboratory Ressources, National Research Council.
- Diet (e.g. ad libitum): yes, Wayne Guinea Pig Diet, ad libitum, food was checked daily and added or replaced as needed. Feeders were designed to reduce soiling, briding and cattering.
- Food analysis: There were no contaminants that were reasonably expected to be present in the dietary material known to be capable of interfering with the purpose or conduct of the study.
- Water (e.g. ad libitum): fresh tap water was available ad libitum, Water is monitored for contaminants at periodic intervals according to standard Operating Procedure-
- Acclimation period: 5 days
- Sanitanization: Wate material removed aily. Cages and feeders sanitized every two weeks.
- Rationale for test system: This test will readily detect moderate to strong skin sensitizers and thus act as an early warning against the use of such materials for human testing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12hours lght and 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 25% /0.4 ml
- Day(s)/duration:
- 1/wk for 3 wks/6 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 80% Ethanol
- Remarks:
- Naive animals
- Concentration / amount:
- 10%/ 0.4 ml
- Day(s)/duration:
- Day 14/6 h
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 80% Ethanol/test animals
- Concentration / amount:
- 10%/ 0.4 ml
- Day(s)/duration:
- Day 14/6 h
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 80% Ethanol/ Vehicle animals
- Concentration / amount:
- 10%/0.4 ml
- Day(s)/duration:
- Day 14/6 h
- Adequacy of challenge:
- not specified
- No.:
- #4
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 80% Ethanol/Positive control
- Concentration / amount:
- 10%/0.4 ml
- Day(s)/duration:
- Day 14/6 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test article-20 animals
Positive control-6 animals
Negative control-10 animals
Naive challenge-4 animals
Dose range-4 animals - Details on study design:
- RANGE FINDING TESTS: Prior to intiation of the study, the irritation potential was determined. Four unexposed animals (2 males and 2 females) were exposed to four concentrations of the test material by the technique described in site preparation treatment. In this test, both sides of the animal were shaved and exposed to four concentrations of the material. For grading of the response the procedure described in table 1 for primary challenge was used, except that only 24 hour grade were obtained. The dose chosen for indiction was 25%.
SITE PREPARATION AND TREATMENT:
The left shoulder of each animal was clipped free of hair with an Oster Model A2 clipper twenty-four hours prior to the 1st, 2nd and 3rd application of the test material. The shaved area was approximately 5x10 cm, i.e. 10% of the body surface.
The test material was applied to 20 guinea pigs (10 males and 10 femelas). The material was applied beneath a 37X40 mm Parke-Davis Readi-Bandage, (Park-Davis and Company, Greenwood, South Carolina) and covered with dental dam. The patch and dam were held in place with clips attached to the sides of the guinea pig restrainer.
The patches were allowed to remain in place for six hours, after which the rubber dams and patches were removed. The treated sites were examined after each dosing day and scored at 24 and 48 hours according to table I. This procedure was performed was performed once a week for three weeks, a total of three six-hour inductions. The initial body weight of the animals was recorded. A concurrent positive control group consisting of six guinea pigs (3 males and 3 females) was treated with (0.3%) 1-chloro-2,4-dinitrobenzene in 80% ethanol (80:20 ethanol/distilled water). An additional group of ten guinea pigs (5 males and 5 females) was treated with vehicle alone (Ethanol 80%).
MAIN STUDY
A. INDUCTION EXPOSURE
Frequency and duration of administration:
- three (3) inductions: test item 25% (experimental group)
- three (3) inductions: DNCB 0.3% (positive control animals)
- three (3) inductions: Ethanol 80% (vehicle control animals)
Fourteen days after the last induction sensitizing exposure, the animal were challenged im the same manner on a naive site on the left side. Four naive pigs (2 males and 2 females) were induced with the test material at a 10 % concentration, on challenge day in the same manner. Local and systemic effects were observed. Twenty four hours after the challenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New-York, 10017). The depilatory was placed on the test sites and surrounding areas and left for no more than 30 minutes. A minimun of two hours afetr depilation test sites were graded. the grading was repeated 24 hours later (48 hours)
B. CHALLENGE EXPOSURE
- One (1) challenge: Test item 10% (naive animals)
- One (1) challenge: Test item 10% (experimental animals)
- One (1) challenge: DNCB 0.3% (positive control animals)
- One (1) challenge: Ethanol 80% (vehicle control animals)
- Challenge controls:
- - One (1) challenge: DNCB 0.3% (positive control animals)
- One (1) challenge: Ethanol 80% (vehicle control animals) - Positive control substance(s):
- yes
- Remarks:
- 0.3% 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- A positive response was elicited in the animals receiveing the positive control article, 1-Chloro-2,4 dinitrobenzene (DNCB)
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Hours after challenge:
- 24
- Group:
- test chemical
- Remarks on result:
- positive indication of skin sensitisation
- Hours after challenge:
- 48
- Group:
- test chemical
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Results:
A positive response was elicited in the animals receiving the positive control article, 1 -chloro-2,4 dinitrobenzene (DNCB).
No positive responses were observed in the vehicle control animals.
Positive responses were observed in the experimental group at 24 and 48 hours after treatment.
One positive response was observed in the naive animals receiving the test item at 10% concentration at 48 hours after treatment. Since a grade of one (1) was seen on the naive animals, then the reaction of the test article group animals that exceed the most severe naive reactions are considered to be positive scores.
Delayed contact hypersensitivity in Guinea Pigs Incidence and severity of responses at challenge.
Challenge | ||||
Naive site | ||||
24 hours | 48 hours | |||
Test Article | Incidence | Severity | Incidence | Severity |
Test item (10%) | 9/20 | 1.6 | 8/20 | 1.3 |
Naive animals ( test item (10%) | 0/4 | 0 | 1/4* | 0.3 |
DNCB (0.3%) | 6/6 | 3.0 | 6/6 | 2.5 |
ethanol (80%) | 0/10 | 0.2 | 0/10 | 0.1 |
*Since a grade of one (1) was seen on the naive animals, then the reactions of the test article group animals that exeed the most severe naive reactions are considered to be positive scores.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test article was found to cause delayed hypersensitivity in guinea pigs under the tested conditions. Therefore the substance is classified as cateogry 1B according to CLP Regulation
- Executive summary:
In a preliminary dose-range-finding study to detrmine the highest non-irritating dose, four animals (2males and 2 females) were exposed to four different concentrations of the test item.
Based upon the results of the dose-range-finding study and in discussion with the sponsor, the dose chosen for induction was 25% and the dose chosen for challenge was 10%.
In order to determine if the test article is capable of causing delayed contact hypersensitivity, the test item was dermally applied to twenty guinea pigs (ten males and ten females) for a total of three six hour insult periods at a 25% concentration.
Another group of six guinea pigs (three males and three females) was treated with 1 -chloro-2,4, dinitrobenzene at a 0.3% concentration for a total of three six-hour insult periods. An additional group of ten guinea pigs (five males and five females) was treated with vehicle for a total of three six-hour insult periods.
Fourteen days afetr the last induction period, all animals were challenged at a naive site. A positive response was elicited in the animals receieving the positive control article, 1 -chloro-2,4 dinitrobenzene (DNCB). Positive responses were observed in the experimental group at 24 and 48 hours afetr treatment. No positive responses were observed in the vehicle control animals. One positive response was observed in the naive animals receiveing the test item at a 10% concentration at 48 hours after treatment. Since a grade of one (1) was seen on the naive animals, then the reactions of the test article group animals that exceed the most severe naive reactions are considered to be positive scores.
Based upon the observations made in the delayed contact hxpersensitivity study in guinea pigs, the test item, induced at 25% and challenged at 10% resulted in delayed contact hypersensitivity in gunea pigs.
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