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Administrative data

Description of key information

Acute oral toxicity

The test article, Oct-7-en-1-ol meets the criteria for classification for skin corrosivity from data generated in the EpiDerm in vitro irritation [1] and corrosivity [2] models. In accordance with the ECHA Chapter R.7a guidance [3], a waiver is requested as Oct-7-en-1-ol is classified as skin corrosion (Category 1) and therefore an acute oral toxicity study to address this endpoint is not required. Consequently, the required standard information in Column 2 are met. Based on the available skin irritation and skin corrosion data, it is scientifically robust to submit a waiver for the acute oral toxicity endpoint as stated in the R.7a guidance for REACh.

 

Based on the skin corrosion (Category 1) classification, classification for acute oral toxicity is not warranted.

 

References

1.Mochizuki, H. (2017).In vitro skin irritation study of OEA using EpiDerm. Ina Research Inc., Nagano, Japan. Unpublished report No.: DK16295

2. Suzuki, M. (2017).In vitro skin corrosion test of OEA using EpiDerm SCT (EPI-200). Chemicals Evaluation and Research Institute, Japan, Hita. Unpublished report No.: K10-0242

3. ECHA (European Chemicals Agency). Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. December 2016

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
n/a

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
n/a

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
n/a

Additional information

Acute dermal and inhalation toxicity

Under the requirements of REACh, Annex VII the acute toxicity endpoint is limited to the oral route, with no requirement to address the dermal or inhalation routes. However, in accordance with the ECHA Chapter R.7a guidance, a waiver is requested as Oct-7-en-1-ol is classified as skin corrosion (Category 1) and therefore an acute oral toxicity study to address this endpoint is not required. Consequently, the required standard information in Column 2 are met. Based on the available skin irritation and skin corrosion data, it is scientifically robust to submit a waiver for the acute oral toxicity endpoint as stated in the R.7a guidance for REACh.

Justification for classification or non-classification

Comparison with the CLP criteria

Based on the available skin irritation and skin corrosion data, it is scientifically robust to submit a waiver for the acute oral toxicity endpoint as stated in the R.7a guidance for REACh. Based on the skin corrosion (Category 1) classification, classification for acute oral toxicity is not warranted.