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EC number: 264-092-6 | CAS number: 63310-16-7
- 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:
- 12 November 1981 to 11 January 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing study
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)
- EC Number:
- 264-092-6
- EC Name:
- 9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)
- Cas Number:
- 63310-16-7
- Molecular formula:
- C21H39O5B (based on the representative structure below)
- IUPAC Name:
- 2-hydroxy-3-{[hydroxy({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}propyl (9Z)-octadec-9-enoate; 3-{[bis({2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy})boranyl]oxy}-2-hydroxypropyl (9Z)-octadec-9-enoate; {2-hydroxy-3-[(9Z)-octadec-9-enoyloxy]propoxy}boronic acid
- Test material form:
- not specified
- Details on test material:
- - Physical state: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Labs, Wilmington, Massachusetts, USA
- Age at study initiation: 56 days
- Weight at study initiation: 434 - 649 g
- Housing: individually in wire-bottom cages
- Diet: Purina Guinea Pig Chow 5025® ad libitum. Fresh lettuce provided weekly
- Water: purified water ad libitum
- Acclimation period: 28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 22 ºC
- Humidity (%): 48 - 77 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 12 November 1981 to 11 January 1982
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: See "Details on study design" for information
- Concentration / amount:
- See "Details on study design" for information
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: See "Details on study design" for information
- Concentration / amount:
- See "Details on study design" for information
- No. of animals per dose:
- 20 animals per treatment group
- Details on study design:
- A. INTRADERMAL INDUCTION EXPOSURE
A 4 x 6 cm area on the back, behind the shoulder girdle, was clipped one day prior to treatment. Pre-test screening on surplus animals indicated that 1% test material (w/v in peanut oil) was the maximum concentration not causing local necrosis or ulceration upon intradermal injection. In the following anterior to posterior order, three pairs of intradermal injections were made along the back within a 2 x 4 cm area corresponding to the size of a patch applied one week later:
(a) 0.1 mL 1% test material w/v in peanut oil
(b) 0.1 mL Freund's Complete Adjuvent (emulsion prepared by blending the commercial adjuvent with equal volume of sterile saline)
(c) 0.1 mL 1% test material w/v in Freund's Complete Adjuvent (prepared by first dissolving/mixing oil-soluble test material in the commercial adjuvent before adding the appropriate volume of sterile saline)
The first two pairs of injections were given approximately 0.3 cm apart, the final pair were located 0.6 cm caudally from the second pair.
The concurrent control group received injections as follows:
(a) 0.1 mL peanut oil alone
(b) 0.1 mL Freund's Complete Adjuvent (commercial adjuvent and sterile saline in a 1:1 volume ratio)
(c) 0.1 mL peanut oil incorporated in Freund's Complete Adjuvent
The ethylenediamine (EDA) group received the following injections:
(a) 0.1 mL 0.1% EDA (w/v) in sterile saline
(b) 0.1 mL Freund's Complete Adjuvent
(c) 0.1 mL 0.1% EDA (w/v) in Freund's Complete Adjuvent
The concurrent control group received the following injections:
(a) 0.1 mL sterile saline
(b) 0.1 mL Freund's Complete Adjuvent
(c) 0.1 mL saline incorporated in Freund's Complete Adjuvent
B. TOPICAL INDUCTION EXPOSURE
One week after the intradermal injections, the same area of the animal's back was reclipped. Pre-test screening on surplus animals indicated 5% test material (w/v in peanut oil) as the appropriate concentration for producing mild-moderate skin irritation upon topical administration. 0.2 mL 5% test material (w/v in peanut oil) was mixed into 0.5 g petrolatum pre-weighed and spread over a 2 x 4 cm patch of Whatman 3 mm filter paper. The patch, with an overlying 5 cm square of polyethylene, was placed on the clipped area and was held in place for 48 hours by a cohesive bandage wrapped around the animal's torso. The concurrent control group was similarly treated with 0.2 mL peanut oil incorporated into 0.5 g of petrolatum. The EDA group was treated with 0.2 mL 5% EDA (w/v in saline) mixed in 0.5 g petrolatum, while its concurrent control group was treated with 0.2 mL saline mixed in 0.5 g petrolatum.
C. CHALLENGE EXPOSURE
Pre-test screening on surplus animals, previously treated with an intradermal injection of Freund's Complete Adjuvent, indicated 1% test material (w/v in peanut oil) as the appropriate non-irritating concentration for topical challenge. Fourteen days after the topical induction, challenge treatment was carried out on both flanks (clipped the previous day) as follows: 0.2 mL 1% test material (w/v in peanut oil) was mixed into 0.5 g petrolatum pre-weighed and spread on a 2 x 2 cm filter paper patch placed on the left flank while 0.2 mL peanut oil alone was mixed into 0.5 g petrolatum pre-weighed and spread on a patch placed on the right flank. A polyethylene square covered each of the patches and was held in places by cohesive wrap for 24 hours. Both the test material induced group and the concurrent control group received identical challenge treatment. Both the EDA-induced animals and the concurrent controls received topical administration of 0.2 mL 10% EDA (w/v in saline), mixed into 0.5 g petrolatum, on the left flank, and 0.2 mL saline (mixed into 0.5 g petrolatum) on the right flank. - Positive control substance(s):
- yes
- Remarks:
- ethylenediamine (EDA)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (intradermal), 5% (topical); 1% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (intradermal), 5% (topical); 1% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% (intradermal), 5% (topical); 1% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% (intradermal), 5% (topical); 1% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% (intradermal), 5% (topical); 10% (challenge)
- No. with + reactions:
- 16
- Total no. in group:
- 18
- Clinical observations:
- Acanthosis abd hyperkeratosis observed.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% (intradermal), 5% (topical); 10% (challenge). No with. + reactions: 16.0. Total no. in groups: 18.0. Clinical observations: Acanthosis abd hyperkeratosis observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% (intradermal), 5% (topical); 10% (challenge)
- No. with + reactions:
- 17
- Total no. in group:
- 18
- Clinical observations:
- Acanthosis abd hyperkeratosis observed.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% (intradermal), 5% (topical); 10% (challenge). No with. + reactions: 17.0. Total no. in groups: 18.0. Clinical observations: Acanthosis abd hyperkeratosis observed..
Any other information on results incl. tables
Bodyweights
No significant differences between treated and control animals were observed.
Mortality
One test material control animal, two EDA-induced animals, and four EDA control animals died within 48 hours after the topical induction treatment. The cause of death for the animals was undetermined.
Histopathology
Pathologic changes in the skin were fairly uniform, consisting of acanthosis and hyperkeratosis. Pulmonary congestion and hepatopathy were observed in both induced and control animals, which died during the study.
Table 1: Skin Irritation Data
Treatment |
24 hour reading |
48 hour reading |
Treatment |
24 hour reading |
48 hour reading |
||||
left flank |
right flank |
left flank |
right flank |
left flank |
right flank |
left flank |
right flank |
||
Test material induced |
0 |
0 |
0 |
0 |
Test material control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1† |
||
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1† |
||
0 |
0 |
0 |
0 |
1 |
0 |
2 |
2† |
||
0 |
0 |
0 |
0 |
0 |
0 |
1 |
3† |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
0 |
0 |
||||||
EDA induced |
3 |
0 |
3 |
0 |
EDA control |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
||
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
0 |
0 |
0 |
1 |
0 |
||
2 |
0 |
3 |
0 |
3 |
0 |
1 |
2† |
||
2 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
||
3 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
0 |
2 |
2 |
2 |
2† |
||
2 |
0 |
2 |
0 |
0 |
0 |
1 |
1† |
||
3 |
0 |
3 |
3† |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
0 |
3 |
0 |
3 |
0 |
||
3 |
0 |
3 |
0 |
2 |
0 |
3 |
0 |
||
3 |
0 |
3 |
0 |
||||||
3 |
0 |
3 |
0 |
† excluded from positive response count; irritation observed on both the treated and control flanks
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Neither the test material induced animals nor the test material control animals responded to challenge treatment. Therefore, no positive sensitisation reactions were observed for the test material and so the test material was considered to be unlikely to be a skin sensitiser. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin sensitisation potential of the test material was investigated following a methodology similar to standardised guidelines OECD 406 and EU Method B.6 using the guinea pig maximisation test. The procedure consisted of two induction treatments (an intradermal injection conducted on day 0 and a topical application scheduled on day 7) followed 14 days later by a challenge treatment (topical application). A concurrent control group was submitted to a similar regimen: induction treatments with the diluent followed by challenge treatment with the test material. A positive control group was also included to confirm validity of the test method employed. Under the conditions of the study neither the test material induced animals nor the test material control animals responded to challenge treatment. Therefore, no positive sensitisation reactions were observed for the test material and so the test material was considered to be unlikely to be a skin sensitiser. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study.
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