Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

IODINE:

Short description of key information:

Short term toxicity to birds (13 days, chicks): LC50 >1500 mg/kg fd (> 197 mg/kg bw/day)

Long term reproductive toxicity to birds (20 weeks, turkeys): NOEC 3.5 mg/kg fd (0.525 mg/kg bw/day)

Key value for chemical safety assessment:

Short-term EC50 or LC50 for birds: 1500 mg/kg food

Long-term EC10/LC10 or NOEC for birds: 3.5 mg/kg food.

Discussion:

There are existing data available on the toxicity of iodine to birds, that has been reviewed in the European Draft Assessment Report for Potassium Iodide. The studies that were assessed in the European review are publically available and have been obtained separately to support the registration of iodine under REACH. The European review of these studies has been summarised below, where appropriate.

Long term/reproductive toxicity to birds

The key data that is assessed in the endpoint summary is a long term reproductive toxicity study to birds (20 weeks, turkeys; Christensen , V.L. and Ort, J.F. 1991) which derived a NOEC of 3.5 mg/kg fd. According to a conversion factor used in the European Draft Assessment Report, the daily food intake of adult birds is equivalent to 15% of their body weight. This gives a NOEC of 0.525 mg/kg bw/day for iodine.

Although this study was conducted in turkeys which is not listed as a recommended species under OECD 206, this long term reproductive study was considered acceptable in the European Draft Assessment Report for Potassium Iodide. Furthermore, the NOEC from this study has been used for the risk assessment in this European report. As this study was not conducted to test guidelines a Klimisch score of 2 (reliable with restrictions) is considered appropriate. This study is therefore considered to meet the REACH data requirements in Annex X. For details on other data that were not used in the European review for risk assessment purposes, see the reference below.

Acute toxicity data to birds

Although this data is not a REACH requirement, there is information available that has been assessed in the European Draft Assessment Report for Potassium Iodide, that has data relevant to iodine. For full details on the assessment, refer to the European review. Data from Baker (2004) noted that potassium iodide is not acute toxic at dietary iodine doses up to 900 mg I/kg bw. However, the European review noted that the available data does not meet the quality criteria normally applied for risk assessment. Other data from Arrington et al. (1967) contained a number of deficiencies, and the non lethal concentration from this 6 week study could not be used as a substitute for an acute LD50. The best available data (Baker et al., 2004) indicates that the acute LD50 for iodine in birds is > 900 mg I/kg bw.

Short term toxicity

Although this data is not a REACH requirement, there is information available that has been assessed in the European Draft Assessment Report for Potassium Iodide, that has data relevant to iodine. For full details on the assessment, refer to the European review. Data from Baker et al., (2003) was considered appropriate in the European review as the study duration and the age of the test animals are more consistent with the requirements of a standard 8 days dietary toxicity test. In this study, chicks (Gallus domesticus) that were administered up to 1500 mg/I/kg fd (in the form of KI) over 13 days resulted in no mortalities in any of the experiments. This is equivalent to a 13 day LC50 of > 1500 mg/I/kg fd. Based on the calculations by the RMS, this is equivalent to an LC50 of >197 mg/kg bw/day (for iodine).

References:

Arrington, L.R., Santa Cruz, R.A., Harms, R.H, Wilson, H.R. (1967) Effects of excess dietary iodine upon pullets and laying hens. Journal of Nutrition 92: 325 - 330

 

Baker, D.H., Parr, T.M., Augspurger, N.R. (2003) Oral iodine toxicity in chicks can be reversed by supplemental bromine. Journal of Nutrition 133: 2309-2312

 

Baker, D.H. (2004) Iodine toxicity and its amelioration. Experimental Biology and Medicine 229: 473 -478

 

Christensen, V.L., Ort, J.F. (1991) Iodine toxicity in large white turkey breeder hens. Poultry Science 70, 2402-2410

 

European Commission, (2008) Draft Assessment Report (DAR) – public version – Initial risk assessment provided by the rapporteur Member State The Netherlands for the new active substance Potassium Iodide (of the review programme referred to in Article 8(1) of Council Directive 91/414/EEC.

Downloaded from:

http://dar.efsa.europa.eu/dar-web/provision