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EC number: 279-399-0 | CAS number: 80118-06-5
Skin irritation: non irritating in vivo (US FHSA, GLP, Read-across, K, rel. 2)Eye irritation:non irritating in vivo (US FHSA, similar to OECD 405, GLP, K, rel. 2)Respiratory irritation: no data available
Table 7.3.1/1: Primary Skin Irritation Scores of Rabbits
Exposure Time (h)
Exposure unit (value)
Erythema and eschar formation:
Mean (24 and 72 h)
In a dermal irritation study, 0.5 mL of undiluted test material was dermally applied on the intact or abraded side surface of 6 New Zealand White rabbits. Test sites were covered with an occlusive dressing for 24 h. Animals were then observed for 72 h for edema and erythema. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the removal of the patch.
Slight to mild erythema and slight edema were observed in the intact skin of all six animals at 24h and 72h observation periods. All the individual mean scores for erythema/eschar or oedema, from gradings at 24 and 72h after patch removal, were below the limit of classification (2.3). At 72h observation period, 4/6 animals were scored for erythema/eschar with a very low score (1). Erythema cleared in the intact skin of two animals during the 72 h observation period and edema cleared in the intact skin of five animals during the 72 h observation period.
Based on the weakness of the observed effects, that remain stable or cleared at 72h time point, and since this study was performed under worst case conditions (24h under occlusive conditions instead of 4h under semi-occlusive conditions), it is highly likely that the slight effects observed at 72h will clear in at least 4/6 animals within a 14 -day observation period.
Based on this expert judgement, the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
Table 7.3.2/1: Eye irritation response data for each animal at each observation time
Score at time
24 h (Day 1)
0 / 0 / 0
48 h (Day 2)
72 h (Day 3)
Mean individual score
0 / 0 / 0 / 0 / 0 / 0
2 / 0 / 1 / 0 / 0 / 1
2 / 0 / 1 / 0 / 0 / 0
1 / 0 / 1 / 0 / 0 / 0
Mean individual score 24, 48 and 72 h
1.67 / 0 / 1.00 / 0 / 0 / 0.33
fully reversible within: 7 days
In an eye irritation study, 0.1 mL of undiluted test material was instilled into one eye of 9 New Zealand white rabbits while the untreated eye remained untreated and served as control. In Group 1, the eyes of six animals were not washed out after instillation of the test material. In Group 2, the eyes of three animals were washed out 4 seconds after instillation of the test material, with distilled water for approximately 10 seconds or until all test material was removed from the eye. Animals were observed at 24, 48 and 72 h after instillation of test material and then on Days 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
One animal in the 4-second washout group of the original study was observed to have corneal damage after 72 h. This finding was thought to be an artifact, as even the no washout group demonstrated absolutely no corneal damage. The 4 second washout group was repeated and no corneal damage was observed.
Conjunctival effects (redness) were observed in three animals of the unwashed group. Those conjunctival redness, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, were below the limit of classification (1.67 / 1 / 0.33 ≤ 2), cleared in one animal during the 48 h reading and in the two other animals during the 7-day observation period.
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Skin irritation / corrosion:
A study was available on the substance itself (Klimisch score = 2). Although the protocol deviates from standard method (no data on test animals, 24-hour exposure instead of 4 -hour, occlusive dressing instead of semi-occlusive dressing, observation at 24- and 72-hour only (no 48-hour scoring), reversibility not assessed but only slight and decreasing effects were osberved at 72 -hour osbervation times) (FDRL, 1979).
based on the weakness of the observed effects, that remain stable or cleared at 72h time point, and since this study was performed under worst case conditions (24h under occlusive conditions instead of 4h under semi-occlusive conditions), it is highly likely that the slight effects observed at 72h will clear in at least 4/6 animals within a 14 -day observation period.
Based on this expert judgement, the test material is not classified as irritant to the skin.
A study was available on the substance itself regarding eye irritation (FDRL, 1979, Rel.2). This eye irritation study was performed prior to the OECD test guideline No. 405 but the protocol is similar to that guidance. Undiluted test material was instilled into the eye of 6 rabbits. The eyes were not rinsed after instillation of the test item. Animals were observed at 24, 48 and 72 h after instillation of test material into eyes and then on day 7.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 0.5 for redness, 0.0 for chemosis, 0.0 for iris lesions and 0.0 for corneal opacity. The observed conjunctival reactions were fully reversible within 7 days.
Thus the registered substance does not require classification for eye irritation.
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP7.
Based on the available data no additional self-classification is proposed regarding skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
Based on the available data no additional self-classification is proposed regarding eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
No information was available regarding respiratory irritation. However, based on the absence of skin or eye irritation, it is unlikely that respiratory irritation occurs.
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.
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