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EC number: 223-529-0 | CAS number: 3943-89-3
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 June 2016 to 19 July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ethyl 3,4-dihydroxybenzoate
- EC Number:
- 223-529-0
- EC Name:
- Ethyl 3,4-dihydroxybenzoate
- Cas Number:
- 3943-89-3
- Molecular formula:
- C9H10O4
- IUPAC Name:
- ethyl 3,4-dihydroxybenzoate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: CBA/J strain, inbred
- Source: Janvier, Le Genest-Saint-Isle, France
- Females: nulliparous and non-pregnant
- Microbiological status of animals, when known: SPF-Quality
- Age at study initiation: ca 10 weeks
- Weight at study initiation: 19.8-24.3 g
- Housing: group housed (dMakrolon MII type cages with a sheet of paper)
- 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
- Indication of any skin lesions: no erythema (transparant /white staining of treatment area at 25 and 60% due to test substance remnants that does not prevent scoring)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 10, 25 and 69%
- No. of animals per dose:
- 5 females/dose
- Details on study design:
- PRE-SCREEN TESTS: in 2 females at 25 and 60% during 3 days
- Compound solubility: maximum solubility was in N,N-dimethylformamide 60% was highest concentration possible
- Irritation: none observed
- Systemic toxicity: none observed
- Ear thickness measurements:no effects (checked at day 1, 3 and 6)
- Erythema scores: none (transparant staining observed)
MAIN STUDY: concentration 0, 10, 25 and 60% based on maximum solubility
treatment of the dorsal surface of the ears on 3 consequetive days, on day 6injection in tail vein of 0.25 mL of sterile phosphate buffered saline containing 20 μCi of 3H-methyl thymidine, 5 hours thereafter excision of the dorsal lymphnodes (visual inspection), pooled lymphnodes were precessed for reactivity measurements that were performed on day 7 with Packard scintillation counter (2800TR).
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: SI ≥ 3
TREATMENT PREPARATION AND ADMINISTRATION: prepared within 4 hours prior to each dosing. Homogeneity was assessed by visual inspection of the solutions.
The dorsal surface of both ears was topically treated (25 μL/ear) with test substance or vehicle - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- EC3 value 17.8%
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Variability:
- SEM 0.4
- Test group / Remarks:
- vehicle control
- Key result
- Parameter:
- SI
- Value:
- 9.1
- Variability:
- SEM 2.9
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 3.2
- Variability:
- SEM 1.0
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 4.5
- Variability:
- SEM 1.9
- Test group / Remarks:
- 60%
Any other information on results incl. tables
Relative Size Lymph Nodes, Radioactivity Counts (DPM) and Stimulation Index (SI)
group |
TS1 (%) |
animal |
Size nodes2 |
DPM3/ animal |
mean DPM ± SEM4 |
mean SI ± SEM |
|||||
left |
right |
||||||||||
|
|
|
|
|
|
|
|
||||
1 |
0 |
1 |
n |
n |
448 |
327 |
± |
83 |
1.0 |
± |
0.4 |
|
|
2 |
n |
n |
178 |
||||||
|
|
3 |
n |
n |
593 |
||||||
|
|
4 |
n |
n |
223 |
||||||
|
|
5 |
n |
n |
193 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
2 |
10 |
6 |
++ |
+ |
1951 |
2963 |
± |
582 |
9.1 |
± |
2.9 |
|
|
7 |
++ |
++ |
5031 |
||||||
|
|
8 |
++ |
++ |
2615 |
||||||
|
|
9 |
++ |
++ |
1867 |
||||||
|
|
10 |
++ |
++ |
3351 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
3 |
25 |
11 |
++ |
++ |
851 |
1059 |
± |
174 |
3.2 |
± |
1.0 |
|
|
12 |
++ |
++ |
477 |
||||||
|
|
13 |
++ |
++ |
1332 |
||||||
|
|
14 |
++ |
+ |
1412 |
||||||
|
|
15 |
+++ |
++ |
1225 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
4 |
60 |
16 |
+ |
+ |
1331 |
1457 |
± |
514 |
4.5 |
± |
1.9 |
|
|
17 |
+ |
+ |
3432 |
||||||
|
|
18 |
+ |
+ |
921 |
||||||
|
|
19 |
+ |
+ |
470 |
||||||
|
|
20 |
+ |
+ |
1129 |
||||||
|
|
|
|
|
|
|
|
1 TS = test item (% w/w).
2 Relative size auricular lymph nodes (-, -- or ---: degree of reduction, +,++ or +++: degree of enlargement, n: considered to be normal).
3 DPM= Disintegrations per minute.
4 SEM = Standard Error of the Mean.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The study is a skin sensitizer. No EC3 value can be calculated as there is no dose-response relationship
- Executive summary:
The substance was tested in an LLNA test at 0, 10, 25 and 60% in N,N-dimethylformamide. Female mice were treated (dorsal surface of both ears) during 3 days. On day 6 animals received radiolabled 3H- methylthymidine and after sacrifice the pooled lymphnodes per animal were assessed for incorporation of radiolabled thymidine. DPM values were increased (SI > 3) compared to vehicle controls at all 3 concentrations without a dose response relationship. The substance is therefore considered to be a skin sensitizer.
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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