Registration Dossier

Diss Factsheets

Administrative data

Description of key information

NOAEL (male/female) ≥ 1000 mg/kg/ day

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The potential toxic effects of the test substance after the repeated administration of the substance were evaluated by considering its analogue substances, due to the absence of available data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.

The toxic effects of Similar Substance 01 to rats after their repeated exposure were evaluated according to the OECD Guidelines 421, 422, 407, EPA OPPTS 870.3650, EPA OPPTS 870.3550, EPA OPPTS 870.3050 and EU B.7. and in GLP compliance. 10 male and 10 female rats were orally exposed to the substance at 0, 100, 300 and 1000 mg/kg bw/day. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to the day prior to scheduled necropsy. Females were exposed for 44-50 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation (up to the day prior to scheduled necropsy). The animals were observed for mortality/viability, clinical signs, functional parameters, food consumption and body weight gain. Blood samples were collected for haematology and clinical biochemistry analysis. The animals were subjected to necropsy, the organ weights and histopathology findings were recorded.

No mortality, changes in motor activity or clinical signs of toxicity, were identified. No toxicologically relevant changes occurred in haematological and in clinical biochemistry parameters of treated rats. Necropsy did not reveal any toxicologically relevant alterations and no toxicologically relevant changes were noted in organ weights and organ to body weight ratios.

Treatment with the substance by oral gavage in male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg revealed no parental toxicity up to 1000 mg/kg. Based on these results, a NOAEL of at least 1000 mg/kg bw/day was derived.

All the information available on the repeated dose toxicity of the rest of the similar substances was summarized in the file attached below.

Justification for classification or non-classification

For the classification of the substance as STOT-RE, the dose in which significant toxic effects are observed, is taken into consideration. If this dose is in the range of the guidance values indicated in the CLP Regulation (EC) No. 1272/2008 Annex I: 3.9.2.9.6 and Annex I: 3.9.2.9.7 then the substance is classified in Category 1 or Category 2 respectively.

Since, in the repeated dose toxicity study no significant toxic effects were observed up to the highest tested concentration and no LOAEL was determined, the substance is not classified for STOT-RE according to the CLP Regulation (EC) No. 1272/2008.