Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
Although the acute dermal toxicity study was not requested by ECHA in a Compliance Check, the SIEF decided to conduct the study to find answers to the question whether 1,4-BDDMA has the potential to induce systemic toxicity after dermal application. The question has arisen since there were unclear, potential systemic effects observed in the LLNA (see Chapter 7.4.) with the registered substance that need to be clarified.
“On day 3, all test item treated animals showed unspecific clinical signs: reduced spontaneous activity, ruffled fur and hunched posture. After application, the animals tried to burrow themselves in the bedding. Furthermore, the animals treated with test item concentrations of 50 and 100% showed eye lid closure and abnormal walk on day 3. On day 4 all animals treated with test item concentrations of 50 and 100% showed ruffled fur and two animals treated with a test item concentration of 100% showed reduced spontaneous activity. Whether the clinical symptoms observed were signs of mild systemic toxicity or mere reactions to the irritant properties of the test item cannot be stated.
No cases of mortality were observed.
Burrowing in the bedding and ruffled fur are often observed in LLNA-studies since the mice do not like to have oily or wet substance on their fur. The mentioned signs can be interpreted as signs of discomfort linked with the dermal application. The increase of the body weight observed in all animals is a clear sign that the animals are healthy. Due to the potential oral intake of the test material by preening themselves or by preening the fur of another mouse, a systemic effect after oral administration cannot not be excluded completely.” (cited from the study report of LLNA)
The study will be conducted at ICCR Roßdorf, In den Leppsteinswiesen 19, 64380 Roßdorf, Germany. Regarding the study plan, we expect the draft report on 31st July 2021.
The REACH dossier will be updated without undue delay once the study finalised.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Results and discussion

Applicant's summary and conclusion