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EC number: -
CAS number: -
The results from the acute dermal irritation and skin irritation test
analysis were negative for skin irritation of the test material.
The results from the Bovine Corneal analysis and acute eye irritation
study were negative for eye irritation of the test material.
Therefore the test material did not meet the GHS criteria to be
classified as a skin or eye irritant.
The study was performed to assess the acute dermal irritation/corrosion of E Stage 3 intermediate in Japanese White rabbits. The method was designed to be in accordance with the guidelines for the testing of chemicals 'Acute Dermal Irritation/Corrosion' (404) published by the Ministry of Environmental Protection of People's Republic of China in the year 2013.
Three male rabbits were used for the study. A quantity of 0.5g of the test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control. Clinical signs were performed once daily throughout the study. The skin sites of each animal for signs of erythema/eschar and oedema were all recorded immediately, and 1, 24, 48 and 72 hours after patch removal. All local toxic effects on skin as well as systemic toxicity were also fully described and recorded. Dermal reactions (erythema/eschar and oedema of test sites were scored at approximately 24, 48 and 72 hours after patch removal. Mean scores of erythema/eschar or oedema at 24, 48 and 72 hours were calculated for tested skins after patch removal. Individual animal body weights were recorded on the day of dosing and on the completion of fiinal observations.
No abnormal signs or symptoms were observed in any animal throughout the course of the test. The scores of erythema/eschar and oedema for all animals at approximately 24, 48 and 72 hours were all 0 after patch removal. All animals showed expected gain in bodyweight during the study.
Based on the above results, E Stage 3 intermediate was considered to have no irritant effects on the skin of rabbits was classified as 'unclassified' according to GHS classification for eye irritation.
The EpiDerm™ Skin Model (MatTek Corporation, MA, USA) was used to assess
the potential dermal irritation of the test article. The MTT
conversion assay, which measures the NAD(P)H-dependent microsomal enzyme
reduction of MTT (and to a lesser extent, the succinate dehydrogenase
reduction of MTT) to a blue formazan precipitate, was used to assess
cellular metabolism after exposure to A1298847.0. The protocol was based
upon the OECD guideline, “In Vitro Skin Irritation: Reconstructed Human
Epidermis Test Method” (TG 439)2.
The test article, the positive control (5% Sodium Dodecyl Sulfate
(SDS)), and the negative control (Calcium & Magnesium Free-Dulbecco’s
Phosphate Buffered Saline (CMF-DPBS)), were treated in triplicate
EpiDermTM tissues for a 60±1 minute exposure period, followed by a
42-hour post-exposure expression period. Since A-1298847.0, is a solid,
25 μL of sterile CMF-DPBS was added to the tissue surface prior to the
addition of the solid test article (which was added using a 25 mg dosing
spoon). The test article was mixed on the surface of the tissues using a
sterile glass rod.
Small amounts of residual test article were noted on the tissues treated
with the test article, A-1298847.0 (tissues 2 and 3 only) after the
rinsing process. The test article was attempted to be removed from the
exposed EpiDerm™ tissues using cotton-tipped applicators soaked in
CMF-DPBS. The test article prolonged the exposure to the tissues, which
may have influenced the toxic effect; however, all of the tissue
viabilities were >50%, therefore, there was no significant impact on the
final prediction for the test articles.
A test article was predicted to be an irritant (GHS Category 1 or 2)
when the mean relative viability of the triplicate-treated tissues is
≤50% of the mean viability of the negative control. A test article was
not predicted to be a skin irritant (GHS No Category) when the mean
relative viability of the triplicate tissues was >50%. The mean
viability of the test articles was 100.2% ± 11.19, therefore A-1298847.0
is classed as a non-irritant.
The study was performed to assess the acute eye irritation/corrosion of E Stage 3 Intermediate in Japanese White rabbits. The method was designed to be in accordance with the guidelines for the testing of chemicals 'Acute Eye Irritation/Corrosion' (405) published by the Ministry of Environmental Protection of People's Republic of China in the year 2013.
Three male rabbits were used for the study. Each animal was administered 0.1g of the test item in the right eye. The untreated left eye served as the control. The rabbits were observed and recorded for initial reaction immediately, 1, 24, 48 and 72 hours after administration. Mean scores of ocular lesions at approximately 24, 48 and 72 hours after administration were calculated for treated eyes. Individual animal body weights were recorded during the study.
During the initial test, one animal showed iris congestion, swelling, moderate circum corneal hyperaemia, conjunctivae redness and swelling at 1 hour and recovered at 48 hours after administration. During the confirmatory test, the two animals showed conjunctivae redness at approximately 1 hour and recovered at 24 hours after administration. The mean scores of iris and conjunctivae redness were both 0.3. No abnormal clinical signs were observed and all animals showed expected gain in bodyweight during the study.
Based on the results in the Japanese White Rabbit, E Stage 3 Intermediate could produce reversible eye irritant reactions and was classified as 'unclassified' according to GHS classification criteria for eye irritation.
The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test article to isolated bovine corneas. Bovine corneas, obtained as a byproduct from freshly slaughtered animals, were mounted in special holders and exposed to the test article. An In Vitro Score was determined for each test article based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. The methods and procedures used in this assay were consistent with OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2017)
A-1298847.0 was administered to the test system as 20% (w/v) (200 mg/mL) dilutions in sterile, deionized water. The test article dilution was prepared by weighing the test article into a conical tube, adding sterile, deionized water, until a 20% (w/v) dilution was achieved, and then vortexing the dilution for approximately 1 minute prior to application. The positive control (a 20% (w/v) dilution of imidazole prepared in Complete Minimal Essential Medium (without phenol red)) and the negative control (sterile, deionized water) were tested concurrently.
Four corneas were incubated in the presence of the test article and three in the presence of the control at 32 ± 1ºC .for four hours. After removal of the test or control article from the corneas, a final opacity was determined (i.e., the corneas did not receive a post-exposure incubation). The opacity value was determined to be -2.3, the OD490 value is -0.012 and the in vitro score calculated as 2.1.
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