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EC number: 277-288-1 | CAS number: 73138-39-3
- 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:
- 05 Aug 2004 - 11 Oct 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- Challenge on day 27 instead of day 20-22; lack of details on topical induction exposure; lack of details in report; no rechallenge conducted; no justification for non-LLNA method
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des Produits Chimiques, Paris, France, 2004
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No justification was given in the study report.
Test material
- Reference substance name:
- Fatty acids, coco, esters with 1,3-butanediol
- EC Number:
- 277-288-1
- EC Name:
- Fatty acids, coco, esters with 1,3-butanediol
- Cas Number:
- 73138-39-3
- Molecular formula:
- not applicable, the substance is UVCB
- IUPAC Name:
- Fatty acids, coco, esters with 1,3-butanediol, UVCB
- Test material form:
- liquid
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
- Source: Centre de Production animale (F-45160 Olivet)
- Females (if applicable) nulliparous and non-pregnant: not stated
- Microbiological status of animals, when known: not stated
- Age at study initiation: not stated
- Weight at study initiation: 267g - 392g
- Housing: not stated
- Diet: not stated
- Water: not stated
- Acclimation period: 5 days
- Indication of any skin lesions: not stated
ENVIRONMENTAL CONDITION
- Temperature (°C): 17-25
- Humidity (%): 48-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
- IN-LIFE DATES: 19 Aug 2004 - 24 Sep 2004 (main study)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- a) 100 % (pure test material), b) 50 % FCA in physiological saline, c) 50 % FCA mixed 1:1 with pure test material
- Day(s)/duration:
- 1st induction by injection on day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- other: epicutaneous (occlusive dressing not stated)
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % pure test material
- Day(s)/duration:
- not stated (application on day 7)
- Adequacy of induction:
- other: skin pre-treated with 10% sodium lauryl sulfate
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- on day 27 / 24-hour exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- on day 27 / 24-hour exposure
- Adequacy of challenge:
- other: half of highest non-irritating concentration
- No. of animals per dose:
- 10 animals were in the treated group; each of these 10 animals was challenged with 50% (in paraffin oil) and 100% pure test material on different anatomical sites
- Details on study design:
- RANGE FINDING TESTS:
Pre-test in 2 female guinea pigs by:
- intradermal injection at pure (100%) and diluted 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil: No necrosis at any dose
- topical under 24h occlussive dressing at pure (100%) and diluted 50%, 25% and 12.5% in olive oil: No cutaneous reaction
Pre-test in 3 female guinea pigs:
After induction by intradermal injections with olive oil and by topical application with paraffin oil, and a 18-day rest phase, the challenge phase under occlusive dressing for 24 hours consisted in a single topical application of the test product at the following concentrations: pure (100%) and diluted at 50%, 25% and 12.5% in paraffin oil: no cutaenous reaction
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and topical, respectively)
- Exposure period: intradermal on day 0, topical on day 7
- Test group (10 females):
Intradermal induction on day 0:
a) 2 intradermal injections of the product pure (100%)
b) 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50 % in in a physiological saline solution
c) 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product pure (100%)
Topical induction on day 7:
On the same zone, with the product at 100%, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl sulfate at 10%.
- Control group: 5 females, negative controls, no induction treatment
- Site: intradermal and topical induction on the same zone, anatomical region not stated
- Frequency of applications: 2 intradermal injections per induction substance [three substances as detailed above under a), b), and c)] and 1 topical application
- Duration: Duration and dressing of topical induction not stated
- Concentrations: intradermal 100% and 50%, topical 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: on day 27
- Exposure period: 24 h
- Test groups: 10 females
- Control group: 5 females
- Site: not stated
- Concentrations: 50% and 100% of test material applied to each animal
- Evaluation (hr after challenge): 24, 48 and 72 hours after the challenge phase - Challenge controls:
- 5 animals; the control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole and Neomycin sulfate
Results and discussion
- Positive control results:
- >30% positive responses at testings conducted with: 50% 2-mercaptobenzothiazole in May 2004, 75% Neomycin sulfate in Mar 2003, and 75% Neomycin sulfate in Jan 2002.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- Score 1 erythema
- Remarks on result:
- other: 60%
- Remarks:
- of tested animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Score 2 erythema
- Remarks on result:
- other: 20%
- Remarks:
- of tested animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Score 1 erythema
- Remarks on result:
- other: 20%
- Remarks:
- of tested animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Three score 1 erythema and one score 2 erythema
- Remarks on result:
- other: 40%
- Remarks:
- of tested animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Score 1 erythema
- Remarks on result:
- other: 40%
- Remarks:
- of tested animals
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- other: testings done on 18 May 2004 with 2-Mercaptobenzothiazole
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: testings done on 18 May 2004 with 2-Mercaptobenzothiazole
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No of Animals |
M.N.I.C. (100%) |
½ |
M.N.I.C. (50%) |
|||||||||
24 hours |
48 hours |
72 hours |
24 hours |
48 hours |
72 hours |
|||||||
NEGATIVE CONTROL GROUP |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
(Vehicle) |
|
|
|
|
|
|
|
|
|
|
|
|
N° C 0427 F |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
N° C 0428 F |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
N° C 0429 F |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
N° C 0430 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N° C 0431 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
TREATED GROUP (Test product) |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er |
Oe |
N° C 0442 F |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
N° C 0443 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N° C 0444 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N° C 0445 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N° C 0446 F |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
N° C 0447 F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
N° C 0448 F |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
N° C 0449 F |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
N° C 0450 F |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
N° C 0451 F |
2 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
No mortality occured during the study. No clinical abnormalities were detected in body weight records.
A discrete to moderate erythema was recorded after challenge at 100%:
Test group: 40% (4/10) at 24h, 40% (4/10) at 48h, 0% (0/10) at 72h after the challenge phase.
Control: 60% (3/5) at 24 h, 20% (1/5) at 48 h, 20% (1/5) at 72h after the challenge phase.
The reactions observed in the control animals were judged to be skin irritation. Thus,as skin irritation was observed in the control animals, only reactions in the test group animals that exceeded the most severe reactions seen in the control group animals were attributed to skin sensitization.
Therefore, a sensitization reaction was recorded in 10% of the animals 24 hours after the challenge phase, on the area challenged with the test item at 100%. No sensitization reaction was noted 48 and 72 hours after the challenge phase, on the area challenged with the test item at 100%.
.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- The test item did not induce a significant sensitisation reaction when administered to the skin of albino guinea pigs after induction by intradermal injection and topical application.
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