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EC number: 940-223-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-02-28 to 2012-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (Skin Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium cocoyl glycinate (SCG) [INCI]
- IUPAC Name:
- Sodium cocoyl glycinate (SCG) [INCI]
- Details on test material:
- Chemical name: Glycine, N-coco acyl derivs., sodium salts
Constituent 1
Test animals
- Species:
- other: EpiSkin reconstructed human epidermis model
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- organotypic reconstructed three-dimensional model of the human epidermis
Test system
- Type of coverage:
- other: direct application
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- other: negative control: 10µl PBS; positive control: 10µl 5% SDS
- Amount / concentration applied:
- 10 mg + 5 µL aqua dest.
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 +/- 1 h
- Number of animals:
- three replicate tissues per dose group
- Details on study design:
- 3 replicate tissues are dosed with the test item, the negative control (PBS) and the positive control (5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. The isopropanol extracts are measured photometrically at 550 nm.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: mean relative tissue viability
- Value:
- > 50
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean tissue viability of the negative control tissues. Time point: 15 min treatment 42 h post-incubation. Remarks: non-irritant EU CLP and UN GHS: No Category. (migrated information)
- Irritation / corrosion parameter:
- other: other: mean relative tissue viability
- Value:
- <= 50
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean tissue viability of the negative control tissues. Time point: 15 min treatment 42 h post-incubation. Remarks: irritant EU CLP and UN GHS Category 2. (migrated information)
Any other information on results incl. tables
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
absolute OD550 |
1.325 |
1.338 |
1.225 |
0.144 |
0.135 |
0.138 |
1.471 |
1.394 |
1.475 |
1.260 |
1.311 |
1.196 |
0.143 |
0.131 |
0.144 |
1.408 |
1.386 |
1.418 |
|
blank-corrected OD550 |
1.282 |
1.295 |
1.182 |
0.102 |
0.092 |
0.095 |
1.428 |
1.351 |
1.432 |
1.217 |
1.268 |
1.153 |
0.100 |
0.089 |
0.101 |
1.365 |
1.343 |
1.375 |
|
mean OD550of the duplicates (blank-corrected) |
1.250 |
1.282 |
1.168 |
0.101 |
0.090 |
0.098 |
1.397 |
1.347 |
1.404 |
total mean OD550of 3 replicate tissues (blank-corrected) |
1.233* |
0.096 |
1.383 |
||||||
SD OD550 |
0.06 |
0.01 |
0.04 |
||||||
relative tissue viabilities [%] |
101.4 |
103.9 |
94.7 |
8.2 |
7.3 |
8.0 |
113.3 |
109.3 |
113.8 |
mean tissue viability [%] |
100.0 |
7.8** |
112.1 |
||||||
SD tissue viability [%]*** |
4.8 |
0.4 |
2.5 |
||||||
CV [% viability] |
4.8 |
5.6 |
2.2 |
* Corrected mean OD550of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the three positive control tissues is£ 40%
*** the standard deviation (SD) obtained from the three concurrently tested tissues is < 18%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Hostapon SG (70% N-cocoyl glycinate) is not irritating to skin
- Executive summary:
The skin irritant potential of the Hostapon SG (70% N-cocoyl glycinate) was investigated using the EPISKIN-Standard Model (EPISKIN-SMTM). The test compound was applied topically to the EPISKIN-SM tissue for 15 minutes followed by a 42 hour post incubation period and immediate determination of cytotoxic effects via MTT reduction assay. No significant effect was found. Hostapon SG is not skin irritating.
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