Registration Dossier

Administrative data

Description of key information

The oral LD50 of the test item, observed in a GLP compliant OECD 423 study and the dermal LD50 of the test item, observed in a GLP compliant OECD 402 study, is  >2000 mg/kg bw .

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study available is a GLP-compliant guideline study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity:

In a GLP compliant acute oral toxicity study performed according to OECD 423 using the acute toxic class method, female Wistar rats were exposed in two groups of each three rats by gavage to a dose of 2000 mg/kg bw test item dissolved in sunflower oil (TOXI-COOP Zrt. 2013). One animal died in group 1. Clinical signs in group 1 comprised of decreased activity, diarrhea, piloerection observed in all animals and irritability was observed in one animal. The clinical symptoms were detected between treatment day and Day 5. In group 2 decreased activity, diarrhea and piloerection occurred in all animals, but pain reaction and irritability was observed in one animal. The clinical symptoms were detected between treatment day and Day 4. One animal lost body weight in the first week, but the mean body weight of the other animals corresponded to their species and age throughout the study. Autopsy revealed no treatment related pathological changes. The LD50 of the test item was therefore determined to be > 2000 mg/kg bw.

Acute dermal toxicity:

In a GLP compliant acute dermal toxicity study performed according to OECD 402, 5 male and 5 female Wistar rats were exposed to

Reaction product of p-nonylphenol, formaldehyde and diethanolamine, propoxylated at 2000 mg/kg bw by the dermal route (TOXI-COOP Zrt. 2013). The test item, dissolved in sunflower oil was applied semi-occlusive and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortalities occurred. No behavioural changes or systemic toxic signs were noted during the study. Dermal irritation symptoms as very slight to well defined erythema in males and very slight to severe erythema in females were observed on the treatment site. These symptoms were observed in the first week in males and throughout the 14-day observation period in females. Other signs as wounds and/or crusting appeared in males between Day 2 and Day 12. Wounds occurred in all females between Day 1 and Day 14. The body weight development was undisturbed in all male animals. The body weight loss was observed in all females in the first week and in one female in the second week. Four animals did not regain its original body weight. No treatment-related macroscopic alterations of organs and tissues were seen during necropsy. The external alterations (erythema, wounds) occurred in females were in line with the observed local irritant symptoms. Under the experimental conditions, the acute dermal LD50 value of

Reaction product of p-nonylphenol, formaldehyde and diethanolamine, propoxylated is determined to be greater than 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
The study available is a GLP-compliant guideline study, fully adequate for assessment.

Justification for selection of acute toxicity – dermal endpoint
The study available is a GLP-compliant guideline study, fully adequate for assessment.

Justification for classification or non-classification

As the oral and dermal LD50 is >2000 mg/kg bw, classification for acute oral and dermal toxicity is not needed according to the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and according to Directive 67/48/EEC (DSD).