Registration Dossier

Administrative data

Description of key information

Oral:
- male rats, LD50: 2100 mg/kg bw
- male rats, LD50: > 5000 mg/kg bw
- male mice, LD50: > 5600 mg/kg bw
- mice, LD50: > 8000 mg/kg bw
- female rats, LD50: > 15,000 mg/kg bw
- guinea pigs, LD50: 3000 mg/kg bw
- male dogs, LD50: > 2000 mg/kg bw
- female rabbits, LD50: > 2000 mg/kg bw
- dogs: LD50: 3000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 100 mg/kg bw

Additional information

A number of reliable studies plus supporting information is available in multiple species for the acute oral toxicity of Methylparaben. A well documented study showed that male rats were more sensitive than mice. The lowest reliable LD50determined was 2100 mg/kg bw for male Sprague Dawley rats. All results are shown in the “Short description of key information” field.

Justification for classification or non-classification

Due to the findings described above (LD50 oral in rats 2100 mg/kg bw) Methylparaben has not to be classified as acute orally toxic.

It can reasonably be deduced that Methylparaben does not exert systemic toxic effects after dermal application and thus does not have to be classified, because Methylparaben did not cause lethal effects after administration of a single oral dose of up to 2,100 mg/kg bw in rats. Furthermore the substance does not have to be classified as skin irritating and it is unlikely that higher amounts than tested in the acute oral toxicity study will be systemically available via the intact skin barrier. Therefore, testing is not scientifically necessary.

In accordance with Section 1.2 of REACH Annex XI, there is sufficient weight of evidence from several independent sources of information leading to the conclusion that Methylparaben does not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because

- the LD50 value for acute oral toxicity of Methylparaben is >2000 mg/kg bw,

- Methylparaben does not have to be classified as skin irritating, and

- inhalation to consumer is very unlikely to occur, since the substance is embedded in cosmetical matrices for application by the consumer

- risk characterisation calculations show that there is no concern for workers arising from the Methylparaben production (for calculation details please refer to “Waiver_Acute toxicity: inhalation”).

Therefore, it is concluded that testing of acute inhalation toxicity of Methylparaben is not scientifically necessary.