Registration Dossier
Registration Dossier
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EC number: 203-063-4 | CAS number: 102-87-4
Endpoint summary
Administrative data
Description of key information
Skin: - Skin irritation, Rabbit, 4h, OECD 404 severe reaction, erythema score 3.8 (average per animal: 3.7, 4.0, 3.7) and oedema score 2.6 (3.0, 2.7, 2.0), fully reversible within 15d in 2 of 3 cases (BASF SE, 1988, 18H0264/882108) for read across substance tri-n-octylamine
Eye: - Eye irritation, Rabbit, OECD 405: slight to mild signs (cornea, iris and chemosis score are 0, redness of conjunctiva 1.7 (1, 2, 2). Fully reversible within 8 days. (BASF SE, 1988, 11H0264/882109) for read across substance tri-n-octylamine
Key value for chemical safety assessment
Additional information
There is no data available for tridodecylamine. A suitable read across candidate for which data is available is Tri-N-Octylamine (CAS # 1116 -76 -3):
Skin:
In vivo OECD guideline conform studies:
A study of the skin irritant effect was performed with Tri-N-Octylamin according to OECD No 404 (1992); EEC 92/69 - Annex V/B5 (1992) (BASF SE, 1988, 18H0264/882108).
Therefore 3 Vienna white rabbits (2male, 1female) where exposed for 4h to 0.5ml undiluted test material (Tri-N-Octylamine). After 4h the semi occlusive coverage was removed and the application site washed with Lutrol/Water. Readings were taken 30-60min after removal and 24h, 48h, 72h and as well as 8d and 15d after removal. The untreated area of each animal serves as control.
The 24/48/72 hours average scores of all animals was 3.8 (average per animal: 3.7, 4.0, 3.7) for erythema and 2.6 (3.0, 2.7, 2.0) for oedema.
In animal#1 the reaction (redness) was not fully reversible within 15 days, whereas all other animals did not show any reaction (erythema or edema) on day 15.
In result the substance was severe irritating to skin both according to CLP and DSD-DPD.
Eye irritation:
OECD guideline conform studies:
Tri-N-Octylamin was tested for acute irritation effects on eyes according to OECD 405 by single dose application (0.1ml) to the conjunctival sac of 3 male Vienna White rabbits (BASF SE, 1988, 11H0264/882109) and a duration of exposure of 24 hours. The mean cornea score and iris score was 0 (mean of all animals and timepoints). The mean chemosis score was recorded as 0, whereas slight to mild conjunctiva reactions (redness) were observed leading to a mean score (24/48/72 h) of 1 in 1/3 animals and 2 in 2/3 animals). The effects observed were fully reversible within 8 days. According to the test conditions the test substance has to be classified as irritating to the eye Cat 2 according to CLP but is not irritating to the eye according to DSD-DPD.
Justification for classification or non-classification
Skin:
Based on the available information from skin irritation study were gradings between 2.3 and 4 are observed, the substance has to be classified according to EU, UN-GHS (EC 1272/2008 ) as skin irritating Cat. 2 or DSD (67/548/EEC) R38
Labelling for skin irritation:
GHS: skin irritating Cat. 2
DSD: skin irritating R38
Eye:
Based on the available information from eye irritation study thetest substance has to be classified according to Regulation No (EC) 1272/2008 (CLP) as eye irritant Cat 2 but is not irritating to the eye according to Directive 67/548/EEC (DSD-DPD).
Labelling for eye irritation:
GHS: eye irritating Cat 2
DSD-DPD: not irritatingInformation 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.
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