Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 223-445-4 | CAS number: 3896-11-5
Skin: The substance caused transient and very slight irritation to the skin in some animals resulting in an average (24 to 72 hour; all animals) for erythema
and edema 0.5 and 0.06 out of a maximal attainable score of 4, respectively. The effects observed were fully reversible within 7 days.
Eye: No indication for corneal opacity or iritis was seen in any animal (score = 0). No indications for conjunctival irritation were seen in 5 of 6 animals (score = 0).
The treated eye of one animal exhibited conjunctival effects which was reversible within 72 hours (score of 0.67).
Table 1: Results from abraded skin
Er = Erythema
Ed = Edema
Table 1: Results from abraded skin.
Mean body weights
- Positive controls: 408 g
- Test group: 429 g
In a primary dermal irritation study, performed using a method identical to that proposed in 1972 by Proposed Guidelines of the US EPA § 163.81-5 “Primary dermal irritation study”. 0.5 g of 50% of the test substance (no data on purity) in propylene glycol/saline (70:30) solution was applied under occlusive conditions to the intact and abraded skin of 6 New Zealand White rabbits. Treatment was terminated 24 hours following application and the animals were subsequently subjected to observation until skin reactions were fully reversed or otherwise for up to 7 days. Irritation was scored according to the Draize method 24, 48 and 72 hours as well as 4 and 7 days after application.
On non-abraded skin, average (24 h to 72 h) scores for erythema were 0.33 (for each of 5 animals) and 1.33 (one animals) of a maximal attainable score of 4. Average (24 h to 72 h) scores for edema were 0.0 (for each of 5 animals) and 0.33 (one animals) of a maximal attainable score of 4. No signs of skin irritation were evident by day 7 of observation.
Results from the abraded skin are not included in the final appraisal for skin irritation of the test substance because of its gross deviation from today’s acceptable standardized procedures for the appraisal of skin irritation. In this study, the test substance is not a skin irritant (Ciba Geigy Ltd.1979).
This study is suitable for assessment of dermal irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline. The test conditions were even harsher (occlusive, extended exposure) than that described by the actual OECD guideline 404.
In a photoxicity test, the test substance (no data on substance purity) was applied to the shaved back of 10 Hartley guinea pigs. The application area was divided in four areas. Two areas (20 cm2each) were treated with 0.1 mL of the test substance, while the remaining two areas were not treated. Twenty minutes after the application, two of the four sites (one treated site, one untreated site) were exposed to UV-A light at a dosage of approx. 10 J/cm2. The sites were graded for erythema and edema at 24, 48, 72 and 96 hours after exposure using the Draize scoring method. The positive control (8 – Methoxypsoralen) caused the adequate response: erythema and/ or edema were present in 4 of 5 animals at each observation time point up to and including 72 hours after treatment. The effect(s) was/were reversible in 3 of the 4 affected animals by the end of the observation period. No signs of test substance induced skin irritation were evident at any site within the 4 day observation period (Supporting Ciba Speciality Chemical Corp., 2000).
The eye irritation potential of the test substance (no data on purity) was determined in a procedure identical to the procedure described in the Federal register 191.2 (September 1964). 40 mg of the undiluted test substance was applied to the conjunctival sac of one eye of each of 6 Albino rabbits. The other eye remained untreated and served as control. Eyes were not irrigated after treatment. Irritation was recorded after 24, 48 and 72 hours. Appraisal of eye irritation was performed according to the method of Draize. Average Draize scores (24, 48 and 72 hours) were calculated per animal for corneal opacity, iritis, conjunctivae (redness + chemosis + discharge). No indication for corneal opacity or iritis was seen in any animal (score = 0). No indications for conjunctival irritation were seen in 5 of 6 animals. The treated eye of one animal exhibited conjunctival effects which was fully reversible within 72 hours (score of 0.67). In this study, the test substance is not an eye irritant (Ciba Geigy Ltd. 1972).
This study is suitable for assessment of eye irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline 405.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. Studies similar to OECD 405 and OECD 404 are available for eye and skin irritation, respectively. In both studies, the scores were below the threshold for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again