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EC number: 250-280-5 | CAS number: 30673-36-0
- 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:
- 28 Apr - 29 May 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The analytical purity of the test substance was not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted in 1996
- Deviations:
- yes
- Remarks:
- analytical purity of test substance not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Methyl laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl laurate
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: Charles River, Germany
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: 381 g (mean value)
- Housing: groups of 5 animals in metal cages with wire mesh floors
- Diet: free access to standard guinea pig diet (LC 23-B, pellet diameter 4 mm; Hope farms, Woerden, The Netherlands), including ascorbic acid (1600 mg/kg); in addition, hay was provided once a week (B.M.I., Helmond, The Netherlands)
- Water: tap water, diluted with decalcified water, ad libitum (by automatic drinking system: ITL, Bergen, The Netherlands)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 20%
- Day(s)/duration:
- Day 22 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 females for the test group; 5 for the control group
- Details on study design:
- RANGE FINDING TESTS: Prior to the start of the main study the intradermal and epidermal irritancy of the test substance were investigated for selection of suitable test substance concentrations for induction and challenge of the main study. The selection was based on the absence of toxicity. For the Induction phase the highest possible concentration that produced moderate irritation should be determined (including slight necrosis with diameter < 3 mm for intradermal application. The challenge concentration should be the maximum non-irritant concentration. Selection of this concentration depended on a number of factors and exact criteria did not always apply. The test system, procedures and techniques were identical to those used in the main study; Animals were between 5 and 9 weeks old; therefore, body weights could exceed 500 g. Body weights were determined prior to treatment.
Concentrations usd for preliminary range finding test:
Intradermal: 100%, 50%, 20%, 10%
Epidermal: 100%, 50%, 20%, 10%
Intradermal injections: A series of four test substance concentrations were used; the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 mL/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
Epidermal application: A series of four test substance concentrations was used; the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using Metalline patches (2 x 3 cm) mounted on medical tape, held in place with Micropore tape and subsequently Coban elastic bandage. The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure
Based on the results of the preliminary study a 50% dilution of the test substance in corn oil was used for intradermal induction, and the undiluted substance was used for the epidermal induction exposure. A 20% test substance concentration was selected for the challenge exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction on Day 1 and epidermal induction at Day 8 (for 48 h)
- Induction test groups:
Intradermal:
The scapular region was clipped and three pairs of intradermal injections (0.1 mL/site) were made as follows:
A) A 1:1 w/w mixture of Freunds' Complete Adjuvant (Difeo, Detroit, U.S.A.) with water for injection (Fresenius AG, Bad Homburg, Germany).
B) The test substance at a 50% concentration in corn oil
C) A 1:1 w/w mixture of the undiluted test substance and Freunds' Complete Adjuvant
Epidermal:
The scapular area between the injection sites was clipped and subsequently treated with 0.5 ml of undiluted test substance using a Metalline patch (2x3 cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Caban elastic bandage. The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance and the dermal reactions caused by the epidermal exposure were assessed for irritation .
- Induction control animals:
The control animals were treated for induction as described for the experimental animals, except that, instead of the test substance, the vehicle was administered.
- Site: Three pairs of intradermal injections into the scapular region of both sides; one of each pair injected on each side of the midline and from cranial to caudal)
- Concentrations: Intradermal: 50%; Epidermal: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 h under occlusive dressing
- Test groups: 20% test substance
- Control group: 20% test substance
- Site: On one of the flanks (previously clipped)
- Concentrations: 20% in corn oil
- Evaluation (hr after challenge): 48 and 72 h (24 and 48 h after removal of the dressing) - Challenge controls:
- none
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde, tech. 85%
Results and discussion
- Positive control results:
- The skin reactions in the experimental animals observed in response to the 10% and 5% positive control substance concentration in the challenge phase of an independent control experiment were considered indicative of sensitisation, based on the absence of any response in the respective control animals. The positive control substance exposure lead to a sensitisation rate of 100% to both the 10% and the 5% concentrations. From these results it was concluded that the female guinea pig of the albino Dunkin Hartley strain is an appropriate animal model for the performance of sensitisation studies in a Maximisation type of test.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Group:
- positive control
- Dose level:
- 5 and 10%
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 100% sensitisation rate
Any other information on results incl. tables
Induction readings:
Animal number |
Intradermal injection (reading at day 3) |
Epidermal exposure (reading at day 10) |
|||
|
A |
B |
C |
100% |
|
Control |
Erythema |
Edema |
|||
31 |
E2 |
NA |
E3 |
0 |
0 |
32 |
N2 |
NA |
E4 |
0 |
0 |
33 |
E4 |
NA |
E4 |
0 |
0 |
34 |
E2 |
NA |
E3 |
0 |
0 |
35 |
E3 |
E1 |
E2 |
0 |
0 |
Experimental |
|||||
36 |
E2 |
E1 |
E2 |
3 |
2 |
37 |
E3 |
NA |
E3 |
3 |
2 |
38 |
E3 |
E2 |
E4a |
4 |
3 |
39 |
E2 |
E1 |
E3a |
3 |
1 |
40 |
E3 |
E1 |
E4a |
4n |
1 |
41 |
E3 |
E2 |
E3 |
4 |
1 |
42 |
E4 |
E3 |
E4 |
4 |
3 |
43 |
E4 |
E4 |
E4 |
4 |
3 |
44 |
E4 |
E3 |
E4a |
4 |
3 |
45 |
E3 |
E2 |
E3a |
4 |
1 |
A: 1:1 mixture of Freuds´complete adjuvant with water
B: Test substance (50%) in corn oil
C: 1:1 mixture of the undiluted test substance with Freuds´complete adjuvant
a: Moderate erythema visible approx. 2 cm caudally of the injection sites
n: Signs of necrosis
Skin effects intradermal injections:
NA: No abnormalities
E(.): Erythema (grade)
N(.): Signs of necrosis (mm in diameter)
Challenge readings
Animal No. |
Day 24 |
Day 25 |
Comments |
|||
20% |
Vehicle |
20% |
Vehicle |
|||
Control |
||||||
31 |
0 |
0 |
0 |
0 |
|
|
32 |
0 |
0 |
0 |
0 |
|
|
33 |
0 |
0 |
0 |
0 |
|
|
34 |
0 |
0 |
0 |
0 |
|
|
35 |
0 |
0 |
0 |
0 |
|
|
Experimental |
||||||
36 |
0 |
0 |
0 |
0 |
Not sensitized |
|
37 |
0 |
0 |
0 |
0 |
Not sensitized |
|
38 |
0 |
0 |
0 |
0 |
Not sensitized |
|
39 |
0 |
0 |
0 |
0 |
Not sensitized |
|
40 |
0 |
0 |
0 |
0 |
Not sensitized |
|
41 |
0a |
0a |
0 |
0 |
Not sensitized |
|
42 |
0 |
0 |
0 |
0 |
Not sensitized |
|
43 |
0 |
0 |
0 |
0 |
Not sensitized |
|
44 |
0 |
0a |
0 |
0 |
Not sensitized |
|
45 |
0 |
0 |
0 |
0 |
Not sensitized |
a: Skin reactions grade 1 noted at the edges of the application area are considered non-specific, possibly provoked by the edges of the patches.
No deaths occurred. No significant differences in the gain of body weight were observed between treatment and control group.
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:
- CLP: not classified
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