Registration Dossier
Registration Dossier
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EC number: 203-137-6 | CAS number: 103-71-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a not assignable/limited developmental study pregnant mice were applied 9.8 mg/kg bw phenyl isocyanate on day 4, 7, 11, and 15 of gestation. No effects on numbers of corpora lutea, total implants, living implants, preimplantation, postimplantation and total implantation losses were evident. Therefore phenyl isocyanate is regarded as non embryotoxic. No information with regard to reproductive organs is given in the 28-days inhalation study. Since inhaled phenyl isocyanate vapor will react primarily with lung tissue so that other systemic organ systems or tissues would be affected only at exposure concentrations that produce sufficient lung toxicity. But the propensity of phenyl isocyanate to cause lung effects consequently led to secondary effects such as hypoxia that could influence developmental endpoints. Therefore it is not expected to yield useful information from a reproductive or developmental toxicity study of phenyl isocyanate vapor inhalation. Thus reproductive toxicity cannot be excluded, but it seems to be unlikely at nonirritant phenyl isocyanate exposure concentrations.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Additional information
In a not assignable/limited developmental study pregnant mice were applied 9.8 mg/kg bw phenyl isocyanate on day 4, 7, 11, and 15 of gestation. No effects on numbers of corpora lutea, total implants, living implants, preimplantation, postimplantation and total implantation losses were evident. Therefore phenyl isocyanate is regarded as non embryotoxic. No information with regard to reproductive organs is given in the 28-days inhalation study. Since inhaled phenyl isocyanate vapor will react primarily with lung tissue so that other systemic organ systems or tissues would be affected only at exposure concentrations that produce sufficient lung toxicity. But the propensity of phenyl isocyanate to cause lung effects consequently led to secondary effects such as hypoxia that could influence developmental endpoints. Therefore it is not expected to yield useful information from a reproductive or developmental toxicity study of phenyl isocyanate vapor inhalation. Thus reproductive toxicity cannot be excluded, but it seems to be unlikely at nonirritant phenyl isocyanate exposure concentrations.
Toxicity to reproduction: other studies
Description of key information
No data.
Additional information
No data.
Justification for classification or non-classification
As pointed out in the discussion field, reproductive toxicity is unlikely. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification seems not justified.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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