Registration Dossier

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.