Registration Dossier
Registration Dossier
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EC number: 200-870-3 | CAS number: 75-44-5
Endpoint summary
Administrative data
Description of key information
No guideline study on repeated dose toxicity is available for phosgene. Data waiver is claimed
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 study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No repeated dose toxicity study according to international guidelines is available for phosgene. Two repeated inhalation toxicity studies with a limited test design (supporting studies) were conducted to investigate the time course of indicators of lung damage and recovery response (Kodavanti et al., 1997; Franch and Hatch, 1986). A data waiver for the endpoint repeated dose toxicity is claimed.
Remarks on the mechanism of action of phosgene
In acute inhalation studies in rats (exposure duration 30 and 240 min) the comparative analysis of the most sensitive endpoint protein concentration in BAL fluid showed a linear dependence of C x t at double logarithmic delineation (Pauluhn, 2006b). This summarizing analysis proves that phosgene-induced early pulmonary changes at single exposure are determined by the inhaled phosgene dose (C x t), and not by the concentration alone. Since the anatomy and physiology as well as the ventilation pattern of the dog is more similar to those of man than those of the rat, an additional acute inhalation study in dogs was performed by Pauluhn (2006c). In this study a single 30-min exposure revealed neither significant changes in BAL fluid nor adverse histological lung findings at a C x t product of 270 mg/m3 x min. After subchronic exposure of rats to phosgene the clearance of bacteria pointed neither to adaptive nor to additive effects in comparison to acutely exposed animals (Selgrade et al., 1995). Thus, there is no evidence for an increase of severity of effect over time and it is confirmed that the inhalation hazard of phosgene is based on its acute toxicity. In addition, the minimal histological changes at the terminal bronchioles observed in rats at 0.1 ppm showed no time-dependent increase between a 4- or 12-week phosgene exposure (Kodavanti et al., 1997). This view is shared by EU Scientific Committee on Occupational Exposure Limits (SCOEL) that used the studies with acute exposure to derive the OEL (EC documentation SCOEL/SUM/004; European Commission, 2011).
Justification for classification or non-classification
Not classified according to Annex I of Directive 67/548/EEC or according to Annex VI of Regulation (EC) No 1272/2008.
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