Registration Dossier

Administrative data

Description of key information

No data is available for isovaleryl chloride. However, the toxicological profile of the non-branched isomer valeryl chloride and isovaleryl chloride are very similar. Due to their reactivity both acid chlorides react locally with human tissue at the port of entry and/or hydrolyze to form hydrochloric acid and valeric acid or isovaleric acid. Both compounds show high corrosivity (Cat 1A) which explains at least in part their acute toxic effects. There is an acute inhalation toxicity study available which can be used for the assessment of the acute inhalative toxicity potential of isovaleryl chloride.
The LC50 for valeryl chloride in rats was found to be 2.07 mg/L.

Key value for chemical safety assessment

Acute toxicity: via dermal route

Endpoint conclusion

Additional information

Inhalation toxicity

No data is available for isovaleryl chloride. However, study results for the the isomer valeryl chloride is available which can be used for the assessment of isovalerylchloride.

In a GLP compliant OECD 403 guideline study in which rats (5/sex/group) were exposed for 4 hours to 0.35, 2.02 and 4.86 mg/L valeryl chloride, no deaths were observed after a 14-day observation period at the lowest exposure level, 3/5 males and 2/5 females died at the medium exposure level and 4/5 males and 5/5 females at the highest exposure level after 14 days (BASF AG, 1990). The LC50 value was calculated to be 2.07 mg/L. General congestion in all animals, focal hyperemia with emphysema in the lungs (2.02 mg/L) and focal hyperemia with emphysema and edema in the lungs (4.86 mg/L) were observed in the animals that died during the study. Clinical signs included irregular and accelerated respiration, eyelid closure, eye discharge, restlessness and ruffled fur at all exposure levels; additionally: intermittent respiration, salivation, nasal discharge, nose with smear and crusts, stretched position when breathing, squatting posture and deteriorated general state at the mid and high concentration.

 

Oral and dermal toxicity

Further studies regarding acute oral and dermal toxicity do not have to be performed: in accordance with column 2 of REACH Annex VIII as the substance is classified as corrosive to the skin according to Directive 67/548/EEC (C, R35) and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (H314, Category 1A).

Justification for classification or non-classification

The available acute inhalation toxicity data warrants classification with Xn; R20 according to Directive 67/548/EEC and Cat. 3; H331 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.