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EC number: 211-734-8 | CAS number: 692-86-4
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 21 Apr - 10 May 2010
- 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:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Isopropyl laurate
- EC Number:
- 233-560-1
- EC Name:
- Isopropyl laurate
- Cas Number:
- 10233-13-3
- Molecular formula:
- C15H30O2
- IUPAC Name:
- isopropyl laurate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: young adult animals (approx. 9 weeks old)
- Weight at study initiation: weight variation was within +/- 20% of the sex mean
- Housing: Individual housing in labelled Makrolon cages (MI type; height 12.5 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) was supplied as cage-enrichment. The paper was removed on Day 1 prior to dosing and was supplied again after scoring of the ears on Day 3.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 18.9 – 22.6)
- Humidity (%): 40 - 70 (actual range: 37 - 84)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: A preliminary irritation study was conducted in order to select the highest test substance concentration to be used in the main study. In principle, this concentration should be well tolerated systemically by the animals and may give moderate irritation. Two test substance concentrations were tested; a 50% and 100% concentration. The highest concentration was the maximum concentration as required in the test guidelines (undiluted for liquids).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer, based on the test guideline and recommendations done by ICCVAM.The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures. The EC3 value (the estimated test substance concentration that will give a SI =3) was determined, using linear interpolation.
TREATMENT PREPARATION AND ADMINISTRATION:
The dorsal surface of both ears was epidermally treated (25 μL/ear) with the test substance, at approximately the same time per day. The concentrations were mixed thoroughly using a vortex mixer immediately prior to dosing. The control animals were treated the same as the experimental animals, except that the vehicle was administered instead of the test substance. Radioactive measurements were performed using a Packard scintillation counter (2800TR). Counting time was to a statistical precision of ± 0.2% or a maximum of 5 minutes whichever came first. The scintillation counter was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The six-month reliability check with Alpha-hexylcinnamicaldehyde indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 5.1
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 620, 1324 and 1929 DPM respectively. The mean DPM/animal value for the vehicle control group was 375.
Any other information on results incl. tables
Table 1: Skin reactions, body weights and relative size auricular lymph nodes
group
|
test substance1 (% w/w) |
an2 |
Day 1 |
Day 3 |
Day 6 |
|||||
bw (g)3 |
skin reactions dorsal surface ear |
bw (g)3 |
size nodes4 |
|||||||
left |
right |
left |
right |
|||||||
erythema |
oedema |
erythema |
oedema |
|||||||
|
|
|
|
|
|
|
|
|
|
|
1 |
0% |
1 |
22 |
0 |
0 |
0 |
0 |
23 |
n |
n |
|
(vehicle) |
2 |
21 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
|
3 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
|
4 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
|
5 |
23 |
0 |
0 |
0 |
0 |
24 |
n |
n |
|
|
|
|
|
|
|
|
|
|
|
2 |
25% |
6 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
|
7 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
|
8 |
23 |
0 |
0 |
0 |
0 |
23 |
n |
n |
|
|
9 |
23 |
0 |
0 |
0 |
0 |
23 |
n |
n |
|
|
10 |
23 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
|
|
|
|
|
|
|
|
|
|
3 |
50% |
11 |
23 |
1 |
0 |
1 |
0 |
25 |
+ |
+ |
|
|
12 |
21 |
1 |
0 |
1 |
0 |
21 |
+ |
+ |
|
|
13 |
24 |
1 |
0 |
1 |
0 |
24 |
+ |
+ |
|
|
14 |
23 |
1 |
0 |
1 |
0 |
24 |
+ |
+ |
|
|
15 |
23 |
1 |
0 |
1 |
0 |
23 |
+ |
+ |
|
|
|
|
|
|
|
|
|
|
|
4 |
100% |
16 |
23 |
1 |
0 |
1 |
0 |
22 |
+ |
+ |
|
|
17 |
21 |
1 |
0 |
1 |
0 |
20 |
+ |
+ |
|
|
18 |
24 |
1 |
0 |
1 |
0 |
24 |
+ |
+ |
|
|
19 |
22 |
1 |
0 |
1 |
0 |
23 |
+ |
+ |
|
|
20 |
23 |
1 |
0 |
1 |
0 |
22 |
+ |
+ |
1Vehicle: Acetone/Olive oil (4:1 v/v).
2Animal number.
3Body weight (grams).
4Relative size auricular lymph nodes (-, -- or ---: degree of reduction, +,++ or +++: degree of enlargement, n: considered to be normal).
Table 2: Radioactivity measurements (individual animals)
group |
test substance1(% w/w) |
animal |
DPM / animal |
|
|
|
|
|
|
1 |
0% |
1 |
375 |
|
|
(Vehicle) |
2 |
340 |
|
|
|
3 |
328 |
|
|
|
4 |
551 |
|
|
|
5 |
281 |
|
|
|
|
|
|
2 |
25% |
6 |
718 |
|
|
|
7 |
423 |
|
|
|
8 |
427 |
|
|
|
9 |
401 |
|
|
|
10 |
1130 |
|
|
|
|
|
|
3 |
50% |
11 |
1364 |
|
|
|
12 |
1806 |
|
|
|
13 |
1224 |
|
|
|
14 |
1093 |
|
|
|
15 |
1135 |
|
|
|
|
|
|
4 |
100% |
16 |
2283 |
|
|
|
17 |
1429 |
|
|
|
18 |
2219 |
|
|
|
19 |
1878 |
|
|
|
20 |
1835 |
|
1Vehicle: Acetone/Olive oil (4:1 v/v).
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- At test substance concentrations of 50 and 100% erythema and increased size of auricular lymph nodes occurred. The ear thickness was not measured, therefore an ear swelling was not reported. Thus, it cannot be excluded, that the observed effects were caused by local skin irritation, rather than by skin sensitisation. A clear interpretation of the results was therefore not possible.
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.
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