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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Dermal: NOAEL 200 mg/kg bw, rat, OECD 410, Rattray 2000.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

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 adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
GLP-compliant guideline study, Klimisch 1

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
GLP-compliant guideline study, Klimisch 1

Additional information

In a GLP compliant repeated dose 28-day dermal toxicity study, performed according to OECD guideline 410, groups of five male and five female Alpk:APfSD (Wistar-derived) rats were administered 30, 75 or 200 mg test substance/kg/day (in olive oil) by dermal application over a 28 day period (20 applications). A concurrent control group was similarly treated, but olive oil only was applied. Clinical observations, body weights and food consumption were recorded throughout the study and, at the end of the scheduled period, the animals were killed and subjected to an examination post mortem. Cardiac blood samples were taken for clinical pathology, selected organs were weighed and specified tissues were taken for subsequent histopathology examination. The achieved concentration and stability of the dosing solutions was satisfactory throughout the study. There were no mortalities. At a dose level of 200 mg/kg/day, male body weights were reduced and remained lower than controls throughout the study. However, the maximum difference was 6 - 7% and the difference was not statistically significant after day 11. Food consumption in both sexes and female body weights were slightly lower than controls during the first week of the study. There were no compound-related changes in organ weights, macro- or micro-pathology. At a dose level of 75 mg/kg/day there were transient differences in body weights in both sexes but these did not persist beyond the first week of the study. At a dose level of 30 mg/kg/day there were no compound-related effects.


Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Only study available, GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Only study available, GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Justification for classification or non-classification

Based on the findings of the dermal repeated dose toxicity study, classification is not warranted according to the Directive 67/548/EEC.

Based on the findings of the dermal repeated dose toxicity study, classification is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.