Registration Dossier
Registration Dossier
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EC number: 403-730-1 | CAS number: 2687-96-9
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
An acute oral toxicity study with rat (Nitka, 1986) which run on analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) is available which is key study. The LD50 was 2.05 g/kg bodyweight.
Acute inhalation toxicity:
Study waived due to low vapour pressure (0.00204 Pa).
Acute dermal toxicity:
An acute dermal toxicity study (Nitka, 1987) is available which is key study. This study showed that the test substance is not toxic dermally to rabbits.
Key value for chemical safety assessment
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity:
An acute oral toxicity study with rat (Nitka, 1986) which run on analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) was conducted according to the methods described by Hagan served as a guide. Key study. This study showed that LD50 for the test substance was 2.05 g/kg bodyweight.
The results of the acute toxicity studies confirm the relatively low toxic potential of both molecules as shown in the table below. In addition to the high level of similarity, this supports the acceptability of using the results of acute oral toxicity study with N-(n-octyl)-2-pyrrolidinone in the dossier of N-(n-dodecyl)pyrrolidinone.
Comparison of the acute toxicity studies:
Substance |
N-(n-dodecyl)pyrrolidinone |
N-(n-octyl)-2-pyrrolidinone |
|
Route |
Dermal |
Oral |
Dermal |
Species |
Rabbit |
Rat |
Rabbit |
LD50 (mg/kg bw/d) |
> 2000 |
2050 |
> 2000 |
Reference |
Nitka, 1987b |
Nitka, 1986 |
Nitka, 1987a |
Acute inhalation toxicity:
According to REACH Annex VIII column 2, this study can be waived if inhalation exposure to the substance is unlikely. The substance has low vapour pressure (0.00204 Pa), therefore a waiver of this endpoint is justified.
Acute dermal toxicity:
An acute dermal toxicity study had no guideline using rabbits (Nitka, 1987). Key study.
This study showed that the test substance is not toxic dermally to rabbits.
Justification for classification or non-classification
Oral LD50=>2,000 mg/kg (actual value 2.05 g/kg)
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is not classified for the acute toxicity endpoint.
Dermal LD50 = >2,000 mg/kg (actual value >2,000 mg/kg)
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is not classified for the acute toxicity endpoint.
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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