Registration Dossier

Administrative data

Description of key information

The test substance is irritating to the skin and to the eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In a GLP compliant acute skin irritation study performed according to OECD guideline 404, the irritating potential of Reaction product of p-nonylphenol, formaldehyde and diethanolamine, propoxylated was investigated. (TOXI-COOP Zrt., 2013) Three male new Zealand White rabbits were treated once with 0.5 mL pure test substance. Approximately 24 hours prior to the test the hair was clipped from the back and flanks of the animals. The test item was applied under occlusive conditions to the skin for 4 hours. After 4 hours the rest of the test item was removed with water at body temperature. Animals were examined for signs of erythema and oedema, and the responses scored at 1, 24, 48, 72 hours and at 1 and 2 weeks after the patch removal. Test item caused slight to severe skin irritant (erythema) effects, fully reversible within 2 weeks. The animals’ individual mean scores (average of the readings at 24, 48 and 72 hours after patch removal) were 2.66, 1.66, and 3.00. No edema was observed at any time point. After one week crusting and desquamation were observed which was no longer observed at the final observation time 14 days after treatment. During the study the behaviour and general state of animals were normal. There were no notable body weight changes during the contact and observation period. Based on the results of the study, the test substance is considered to be irritating to the skin.

Eye irritation:

In a GLP compliant acute eye irritation study performed according to OECD guideline 405, the irritating potential of Reaction product of p-nonylphenol, formaldehyde and diethanolamine, propoxylated was investigated (TOXI-COOP Zrt., 2013). Three male new Zealand White rabbits were treated once with 0.1 mL pure test substance in the conjunctival sac of the left eye, the untreated right eye served as control. The treated eye was not washed out after treatment. Rabbits were scored for irritating effects after 1, 24, 48, 72 hours and one week. General state and behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period. One hour after the application, slight to moderate redness, moderate to severe chemosis and severe discharge occurred. There was no important change compared with the 1 hour observation at 24, 48 and 72 hours after the treatment. One week after treatment the study was terminated, because all animals were free of symptoms of irritation. Based on the results of the study, the test substance is considered to be irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
The study available is a GLP-compliant guideline study, fully adequate for assessment.

Justification for selection of eye irritation endpoint:
The study available is a GLP-compliant guideline study, fully adequate for assessment.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

According to Directive 67/48/EEC (DSD), the test item should be classified as Xi:R38 "Irritating to skin”, because the mean value of erythema was greater than 2 in two animals. The observed symptoms were evaluated as fully reversible alterations. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the test item should be classified Category 2:H315 "Causes skin irritation", because the mean value of erythema was between 2.3 and 4.0 in two animals.

Eye irritation:

According to Directive 67/48/EEC (DSD), the test item should be classified as Xi:R36 "Irritating to eyes” based on the conjunctival irritation signs observed in the animals. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the test item should be classified Category 2:H319 "Causes serious eye irritation” based on the mean value of conjuctiva redness and/or chemosis of 2 or higher in all 3 animals.