Registration Dossier

Administrative data

Description of key information

In a guideline equivalent in vivo skin irritation study, the read-across substance C16-C18 and C18 unsat., TMAC was corrosive to skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

An in vitro transcutaneous electrical resistance (TER) assay was conducted to assess the skin corrosivity potential of the test substance (50% active ingredient) using skin discs obtained from the pelts of humanely killed young Crl (WI) BR Wistar rats.The test substance was applied to the epidermal surface of three skin discs per contact period, 1, 4, and 24 hours. At the end of the contact period the test substance was removed using a jet of warm tap water. Corrosive substances are found to produce an irreversible loss of normal stratum corneum integrity and function which can be measured as a reduction in the inherent TER. A threshold value of5kΩ has been established below which substances are considered likely to be corrosiveinvivo.The mean electrical resistance measured using low voltage alternating current electronic databridge after 1, 4 and 24 hours was 7, 2.6 and 2.2 kΩ.Under the conditions of the test, the test substance was considered to have the potential to be a skin corrosive (Sanders A, 2002).

A guideline dermal irritation study was conducted with the read-across substance C16-C18 and C18 unsat., TMAC. Six rabbits (both sexes) were treated with 0.5 mL of undiluted test substance (50% active ingredient) in an occlusive patch fixed with adhesive tape and wrapped with an impervious material, for 4 hours. Observations were made at 4 hours, 48 hours and 10 days post-exposure. If the test substance appeared to be corrosive after 4 hours, another study was conducted with a 1 hour exposure period under similar test conditions. The Draize scoring criteria was used for evaluating the corrosion potential. At 4 hours, very slight to well-defined erythema, very slight ischemia and very slight edema were observed, with an average irritation score of 4/8. At 48 hours, there was well-defined to moderate erythema, very slight to slight ischemia and very slight or slight edema and the average irritation score was 5.4/8. After 10 days, slight to distinct incrustation and decreased hair growth was observed. After an exposure period of 1 hour, very slight erythema was observed with an average irritation score of 0.85/8. After 48 hours, there was very slight to moderate erythema and very slight or slight edema and the average irritation score was 1.25/8. No skin effects were observed after 10 days. Under the test conditions, the undiluted test substance (50% active ingredient) was not corrosive after 1 hour occlusive exposure and corrosive after 4 hours of occlusive exposure (van Beek L, 1982).

Eye

Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the eye is met.


Justification for selection of skin irritation / corrosion endpoint:
Well conducted OECD guideline as well as GLP compliant In vivo study.

Justification for selection of eye irritation endpoint:
Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the eye is met.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Skin

In a guideline equivalent in vivo skin irritation study, the substance C16-C18 and C18 unsat., TMAC was corrosive to skin. Therefore based on the read-across approach, C16 -C18 TMAC is also assigned R34 classification according to EC criteria (67/548/EEC) and skin corrosive Category 1C; H314 - causes severe skin burns and eye according to CLP criteria (EC 1272/2008).

Eye

Data waiving was applied in accordance with Annex VII column 2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the eye is met.