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EC number: 944-825-2 | CAS number: -
Toxicological information
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- 48 hour closed patch test under occlusion
- Type of information:
- experimental study
- Remarks:
- 48 hour closed patch test under occlusion
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- exposure-related information
Reference
- Endpoint:
- sensitisation data (humans)
- Remarks:
- 48 hour closed patch test under occlusion
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Qualifier:
- according to guideline
- Guideline:
- other: 48 hour closed patch test under occlusion
- Deviations:
- not specified
- Principles of method if other than guideline:
- This study assesses the potential side effects (skin erythema and oedema reactions) that may occur after applying a cosmetic product to evaluate whether the topical product is safe for consumer use.
The skin area involved in the product application (dorsal) is cleaned with a 70% alcoholic solution to make it more
sensitive to product application. The product is applied non diluted by using the Finn Chamber, a 7 mm diameter
aluminium disk. The Finn Chamber is fixed to the skin with a tape already been tested for its safety that ensure the
occlusive application of the product.
Applied quantity is sufficient to fill the chamber without overflowing from it when applied on the skin. The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed 15 minutes, one hour and 24 hours after Finn Chamber removal. A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control.
Skin reactions are evaluated 15 minutes, 1 hour and 24 hours after patch removal according to the scores reported in table 1, that describes the severity of erythema, oedema or other types of skin irritation - GLP compliance:
- no
- Specific details on test material used for the study:
- SAMPLE IF 3
BATCH LS080611B - Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 25
- Sex: M and F
- Age: 18-60 years old - Controls:
- A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: The product is applied non diluted by using the Finn Chamber, a 7 mm diameter aluminium disk. The Finn Chamber is fixed to the skin with a tape
- Vehicle / solvent: not used
- Testing/scoring schedule and removal: The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed 15 minutes, one hour and 24 hours after Finn Chamber removal.
- Other: A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control.
EXAMINATIONS
- Grading/Scoring system: Skin reactions are evaluated 15 minutes, 1 hour and 24 hours after patch removal according to the scores 0-4 where zero represent a lightly erythema, 2 Clearly visible erythema, 3 moderate erythema and 4 correspond to serious erythema.
- Statistical analysis: For each experimental time Mean Irritation Index (IIM) is calculated by adding erythema mean value and oedema mean value. The tested product is then classified following table which is based on the Mean Irritation Index.
Mean Irritation Index (IIM) / Product classification
< 0,5 / non irritating
from 0.5 to 2.0 / slightly irritating
from 2.0 to 5.0 / moderately irritating
from 5.0 to 8.0 / highly irritating
- Results of examinations:
- SYMPTOMS
-
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 4
- Number of subjects with negative reactions: 21
Anyone shown reactions after 24h. Three subjects shown erythema after 15min and after 1h from the application. Only one female shown also oedema after 15 min and after 1h from the application.
Potential skin irritation of the product has been assessed according to the amended Draize classification. The test substance is considered as NOT IRRITANT
- Conclusions:
- ESTER B is not irritant.
OEDEMA AND ERYTHEMA REACTIONS
| sex | ERYTHEMA 15min | OEDEMA 15 min | ERYTHEMA 1h | OEDEMA 1h | ERYTHEMA 24h | OEDEMA 24h | |
| R047H | F | 0 | 0 | 0 | 0 | 0 | 0 |
| S030E | F | 0 | 0 | 0 | 0 | 0 | 0 |
| D046G | M | 0 | 0 | 0 | 0 | 0 | 0 |
| S093S | M | 0 | 0 | 0 | 0 | 0 | 0 |
| D041L | F | 0 | 0 | 0 | 0 | 0 | 0 |
| L048L | F | 0 | 0 | 0 | 0 | 0 | 0 |
| G080M | M | 0 | 0 | 0 | 0 | 0 | 0 |
| C196S | F | 0 | 0 | 0 | 0 | 0 | 0 |
| S157C | F | 0 | 0 | 0 | 0 | 0 | 0 |
| C076C | M | 0 | 0 | 0 | 0 | 0 | 0 |
| B078M | F | 1 | 0 | 1 | 0 | 0 | 0 |
| V056C | M | 1 | 0 | 1 | 0 | 0 | 0 |
| F026M | F | 1 | 1 | 1 | 1 | 0 | 0 |
| G076M | F | 0 | 0 | 0 | 0 | 0 | 0 |
| R067L | F | 0 | 0 | 0 | 0 | 0 | 0 |
| M115O | F | 0 | 0 | 0 | 0 | 0 | 0 |
| G171A | M | 1 | 0 | 1 | 0 | 0 | 0 |
| S179A | M | 0 | 0 | 0 | 0 | 0 | 0 |
| B083B | F | 0 | 0 | 0 | 0 | 0 | 0 |
| P068M | F | 0 | 0 | 0 | 0 | 0 | 0 |
| L092P | F | 0 | 0 | 0 | 0 | 0 | 0 |
| G032T | F | 0 | 0 | 0 | 0 | 0 | 0 |
| L078N | F | 0 | 0 | 0 | 0 | 0 | 0 |
| D101M | M | 0 | 0 | 0 | 0 | 0 | 0 |
| P093C | F | 0 | 0 | 0 | 0 | 0 | 0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 48 hour closed patch test under occlusion
- Deviations:
- not specified
- Principles of method if other than guideline:
- This study assesses the potential side effects (skin erythema and oedema reactions) that may occur after applying a cosmetic product to evaluate whether the topical product is safe for consumer use.
The skin area involved in the product application (dorsal) is cleaned with a 70% alcoholic solution to make it more
sensitive to product application. The product is applied non diluted by using the Finn Chamber, a 7 mm diameter
aluminium disk. The Finn Chamber is fixed to the skin with a tape already been tested for its safety that ensure the occlusive application of the product.
Applied quantity is sufficient to fill the chamber without overflowing from it when applied on the skin. The product is left in contact with the skin surface for 48 hours. The cutaneous reactions are analysed 15 minutes, one hour and 24 hours after Finn Chamber removal. A Finn Chamber containing a blotting paper disk soaked with distilled water is applied and used as a negative control.
Skin reactions are evaluated 15 minutes, 1 hour and 24 hours after patch removal according to the scores reported in table 1, that describes the severity of erythema, oedema or other types of skin irritation - GLP compliance:
- no
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SAMPLE IF 3
BATCH LS080611B
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 25 humans volunteers
- Time point:
- other: 15 minutes
- Score:
- 0.16
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 25 humans volunteers
- Time point:
- other: 1 hour
- Score:
- 0.16
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 25 humans volunteers
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 25 humans volunteers
- Time point:
- other: 15 minutes
- Score:
- 0.04
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 25 humans volunteers
- Time point:
- other: 1 hour
- Score:
- 0.04
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 25 humans volunteers
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- non irritant
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- non irritant
- Executive summary:
Human patch test do not show evidence of skin irritation
Details on HPT on Ester B are available in Sect. 7.10.4
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