Registration Dossier

Administrative data

Description of key information

Skin: in vivo, rabbit, semiocclusive, 4h, OECD 404: Moderate to severe skin reactions, erythema 2.7 and oedema 2.8, full reversible within 21 days. (Cognis 1997, M.Hoyer)
Eye: in vivo, rabbit, OECD 405: Moderate to severe eye reactions, .(Cognis 1997, M.Hoyer), cornea opacity 1.0; iris lesion 0.0; redness of conjunctiva 2.6; oedema of conjunctiva 2.8, full reversible within 21 days. (Cognis 1997, M.Hoyer)
Respiratory system: in vivo, rat, OECD 403, LC50 mixture of dimethylamides (mainly C8/C10): >3551 mg/m3, but irritation of the respiratory tract (e.g. slower breathing, serous nasal discharge, dyspnea, stridor, hypothermia) (Bayer 1991; J. Pauluhn)

Key value for chemical safety assessment

Additional information

Valid experimental data is available for the assessment of skin and eye irritation

Skin:

The acute skin irritant effect of N,N-Dimethyldecan-1-amide was investigated according to OECD Guideline No. 404 and EEC Guideline B.4 (Cognis 1997, M.Hoyer). Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after termination of exposure.Moderate to severe skin reactions were observed. Under the experimental conditions described in this report, the mean score for erythema was 2.7 (2.00, 3.00, 3.00) and for oedema 2.8 (2.00, 3.33, 3,00). After 21 days rests of scales on both sides were observed in all animals.

Eye:

The acute eye irritant effect of N,N-Dimethyldecan-1-amide was investigated according to the method recommended in the OECD Guideline No. 405 and EEC Guideline B.5 (Cognis 1997, M. Hoyer).Three female albino rabbits were exposed to 0.1 ml of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7, 14 and in two animals 21 days after dosing.Moderate to severe signs of eye irritation were observed among the rabbits. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity 1.0; Iris lesion 0.0; Redness of conjunctiva 2.6; Oedema of conjunctiva 2.8.After 14 days all animals showed hairless areas around the eye. Treatment related adverse eye reactions were fully reverse within 14 (1 animal) and 21 days.

Key study assignment:

As there is only one reliable and relevant study available for each endpoint, this study has been used as key study.

Additional information for respiratory irritation:

Acute inhalation toxicity (mixture of dimethylamides):

A study for acute inhalation toxicity was conducted with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyl-dodecanamide and N,N-dimethyl-hexanamide) in accordance with OECD Guideline No. 403 (Bayer 1991, J. Pauluhn). Therefore 5 SPF-bred Wistar rats were exposed (head/nose only) to 118.5; 586.4; 2007.6 and 3550.7 mg/m3 (analytical determined).Rats subjected to a concentration of 119 mg/m3 air tolerated the exposure without signs occurring. Rats exposed to 586 mg/m3 air exhibited a transient reddening of the nose on the day of exposure and reduced motility. Rats subjected to the max. tested concentration (3551 mg/m3 air; nebulisation of the undiluted test article) exhibited persistent signs causally linked to an irritation of the respiratory tract (slower breathing, serous nasal discharge, dyspnea, stridor, hypothermia). 3551 mg/m3 air was the range at which mortality started for male rats (1 of 5 died). The results of this study show that the respirable test article aerosol had a relatively low acute inhalation toxicity in the rat. The acute potential hazard of the respiratory tract is attributed to the potency of the test substance aerosol to act as a mucosa irritant.LC50 inhalation (aerosol) Rat (exposure: 4 h) > 3551 mg/m3 air.

It must also be noted that such a high concentration of 3551 mg/m3 (analytically determined) is created by a nominal concentration of 50000 mg/m3


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin:

Clear skin irritating effects were observed in a skin irritation study: The scores obtained from the study led to a classification as an irritant to skin (cat. 2) due to criteria of GHS (Regulation (EU) 1272/2008) and to classification Xi R-38 according to EU-criteria DSD (67/548/EEC)

Labelling for skin irritation:

GHS: irritant to skin (cat. 2)

DSD: Xi R-38

Eye:

Clear eye irritating effect were observed in an eye irritation study: The scores obtained in this study led to a classification as an irritating to eye (cat. 2) due to criteria of GHS (Regulation (EU) 1272/2008) and Xi R-36 according to EU-criteria DSD (67/548/EEC)

Labelling for eye irritation:

GHS: irritating to eye (cat. 2)

DSD: Xi R-36

Classification for respiratory irritation:

Based on irritating effects observed in a acute inhalation study(Bayer 1991, J. Pauluhn) the substance has to be labelled as STOT single cat 3 "May cause respiratory irritation" due to criteria of GHS (Regulation (EU) 1272/2008) and Irritating to respiratory system R37 according to EU-criteria DSD (67/548/EEC)