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EC number: 231-816-7 | CAS number: 7756-96-9
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 02 August 2016 until 15 August 2016
- Reliability:
- 1 (reliable without restriction)
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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS (2003, last rev. 2015)
- Principles of method if other than guideline:
- Based on a “Statement on the Scientific Validity of In Vitro Tests for Skin Irritation” of the European Commission (November 2008), official acceptance of the test method in the EU was achieved and implemented in EU, 2008a, Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH; 1st ATP 2009: EC Regulation No 761/2009 of 23 July 2009 amending, for the purpose of its ATP, EC Regulation No 440/2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH, section B46.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 13-16 July 2015, Date of Signature: 14 September 2015
Test material
- Reference substance name:
- Butyl anthranilate
- EC Number:
- 231-816-7
- EC Name:
- Butyl anthranilate
- Cas Number:
- 7756-96-9
- Molecular formula:
- C11H15NO2
- IUPAC Name:
- butyl 2-aminobenzoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Identification: Anthranilsäurebutylester
Batch: 1/12
CAS No.: 7756-96-9
EINECS: 231-816-7
Purity: 99.9%
Appearance: Bright yellow clear liquid
Expiry Date: 02 May 2018
Storage Conditions: At room temperature
Stability in Solvent: Not indicated by the Sponsor
Certificate of Analysis: AZ 1014/Toxd1, dated 2 May 2016
In vitro test system
- Test system:
- human skin model
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µL (47 µL/cm exp. 2 according to guideline) of the undiluted test item was dispensed directly atop the EpiDerm™ tissue and spread to match the surface of the tissue
- Duration of treatment / exposure:
- 60 minutes.
- Number of replicates:
- 3 tissues
Test animals
- Species:
- other: reconstituted human epidermis model
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
30 µL (47 µL/cm2 according to guideline) of the undiluted test item was dispensed directly atop the EpiDerm™ tissue and spread to match the surface of the tissue for a complete treatment time of 60 minutes.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS (MatTek) were used as negative control per tissue.
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 5% SLS solution in deionised water (MatTek)- Duration of treatment / exposure:
- 60 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
Results and discussion
In vivo
- Irritant / corrosive response data:
- Compared to the relative absorbance value of the negative control the mean relative absorbance value was reduced to 8.8% after exposure of the skin tissues to the test item. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential.
- Other effects:
- No
Any other information on results incl. tables
Results after treatment with Anthranilsäurebutylester and the controls (60 minutes exposure time):
Dose |
Tissue |
Absorbance |
Absorbance |
Absorbance |
Mean |
Mean |
Group |
No. |
570 nm |
570 nm |
570 nm |
Absorbance |
Absorbance |
|
|
Well 1 |
Well 2 |
Well 3 |
of |
of three well |
|
|
|
|
|
3 Wells |
blank |
|
- |
- |
- |
- |
- |
corrected |
Blank |
- |
0.037 |
0.038 |
0.038 |
0.038 |
0.000 |
Negative Control |
1 |
1.770 |
1.757 |
1.747 |
1.758 |
1.721 |
Negative Control |
2 |
1.852 |
1.733 |
1.745 |
1.777 |
1.739 |
Negative Control |
3 |
1.748 |
1.700 |
1.675 |
1.708 |
1.670 |
Positive Control |
1 |
0.119 |
0.116 |
0.116 |
0.117 |
0.079 |
Positive Control |
2 |
0.107 |
0.111 |
0.107 |
0.108 |
0.071 |
Positive Control |
3 |
0.103 |
0.104 |
0.104 |
0.104 |
0.066 |
Test Item |
1 |
0.231 |
0.225 |
0.224 |
0.227 |
0.189 |
Test Item |
2 |
0.295 |
0.290 |
0.287 |
0.291 |
0.253 |
Test Item |
3 |
0.260 |
0.261 |
0.264 |
0.262 |
0.224 |
Dose |
Tissue |
Mean |
Rel. Absorbance* |
Relative |
Mean Rel. |
Group |
No. |
Absorbance |
[%] |
Standard |
Absorbance |
|
|
of 3 tissues |
Tissue |
Deviation |
[% of |
|
|
After blank |
1, 2 + 3** |
[%] |
Negative |
|
|
correction* |
|
|
Control]*** |
Blank |
- |
- |
- |
- |
- |
Negative Control |
1 |
- |
100.6 |
- |
- |
Negative Control |
2 |
1.710 |
101.7 |
2.1 |
100.0 |
Negative Control |
3 |
- |
97.7 |
- |
- |
Positive Control |
1 |
- |
4.6 |
- |
- |
Positive Control |
2 |
0.072 |
4.1 |
9.4 |
4.2 |
Positive Control |
3 |
- |
3.9 |
- |
- |
Test Item |
1 |
- |
11.1 |
- |
- |
Test Item |
2 |
0.222 |
14.8 |
14.3 |
13.0 |
|
3 |
- |
13.1 |
- |
- |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue [rounded values]:
*** relative absorbance per treatment group [rounded values]:
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did not led to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 13.0% (threshold for irritancy: ≤ 50%), consequently the test item was irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, Anthranilsäurebutylester is irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Anthranilsäurebutylester by means of the Human Skin Model Test.
The test item passed the MTT- and the colour interference pre-tests.
Each 30 µL of the test item, of the negative control (DPBS), and of the positive control (5% SLS) were applied to each tissue and spread to match the surface of triplicate tissue.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following approximately 69 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD at or higher 0.8 and ≤ 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 4.2% thus ensuring the validity of the test system.
The relative standard deviations between the % variability values of the test item, the positive and negative controls in the main test were below 15% (threshold of the "OECD Guideline for the Testing of Chemicals 439 :In vitroSkin Irritation: Reconstructed Human Epidermis Test Method”: < 18%), thus ensuring the validity of the study.
Compared to the relative absorbance value of the negative controlthe mean relative absorbance value was reduced to 13.0% after exposure of the skin tissues to the test item. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential.
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