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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 July 2012 - 28 August 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with international guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

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: Standard Operating Procedure, In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009), supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM).
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
460-230-6
EC Name:
-
Cas Number:
36484-54-5
IUPAC Name:
Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane
Details on test material:
- Name of test material (as cited in study report): EP-4000S, Chemical name: Phenol,4-4’-(1-methylethylidene)bis-,polymer with 2-(chloromethyl)oxirane and 2-methyloxirane
- Physical state: Light yellow liquid
- Analytical purity: 100%
- Lot/batch No.: 902Y1
- Expiration date of the lot/batch: 7 December 2012
- Storage condition of test material: Room temperature, in the dark

Test animals

Species:
other: EPISKIN three-dimensional human skin model.
Details on test animals or test system and environmental conditions:
The test involves the application of the test substance for 15 minutes to the EPISKIN three dimensional human skin model. The model consists of normal,
human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen.

After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum
has formed. The epidermis surface area supplied is 0.38cm2.
The EPISKIN kits include
assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar.

Test system

Controls:
other: Please refer to above entry
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL applied over each tissue using a positive displacement pipette
Duration of treatment / exposure:
15 ± 0.5 minutes
Observation period:
After 15 ± 0.5 minutes of exposure of the test substance, each tissue was rinsed and the inserts were blotted on absorbent paper to remove remaining sterile Dulbeccos Phosphate Buffered Saline (DPBS), rinsing agent. Each insert was then transferred to a well containing 2 mL maintenance medium and incubated for 42 ± 1 hour at 37°C ± 2 °C in a humidified atmosphere of 5% CO2 in air.
After 42 ± 1 hour, each insert was transferred to a well containing 2 mL of 0.3 mg/mL MTT and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
Number of animals:
The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium.
The positive control was 5% Sodium Dodecyl Sulphate (SDS) in distilled water.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):each tissue was rinsed with 25 mL sterile Dulbeccos Phosphate Buffered Saline (DPBS)
- Time after start of exposure: 15 ± 0.5 minutes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Mean tissue viability
Value:
56.4
Remarks on result:
other:
Remarks:
Basis: mean. Remarks: Predicted as non-irritant. (migrated information)

In vivo

Irritant / corrosive response data:
The test substance, EP-4000S/water solution and water control were colourless after the 15 minute shaking period. The test substance, EP-4000S, had not shown any potential for colouring water.
Other effects:
There was no change in the test substance, EP-4000S/MTT solution or the water control/MTT solution after three hours incubation in the dark at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. The test substance had not interacted with the MTT.

Any other information on results incl. tables

The results of the assay are summarised below:

 Sample           Tissue viability as percentage of mean OD negative control  Prediction MTT endpoint
 

       Replicate Tissues

 Mean +/- SD  
   a  b  c    
 Negative control  102.1  98.0  99.9  100.0 ± 2.0  Not applicable
 Positive control  13.8  16.5  34.5  21.6 ± 11.3  Irritant
 EP-4000S  60.8  60.7  47.7  56.4 ± 7.5  Non-irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was concluded that the test substance, EP-4000S, with a mean tissue viability of 56.4 ± 7.5%, was predicted as non-irritant to the skin.