Alkyl phosphites

Endpoint summary

Description of key information

OECD 401: The acute oral LD50 is >2000 mg/kg bw.
OECD 402: The acute dermal LD50 is >500 mg/kg bw.
Recorded minor effects derive from the corrosive nature of the substance 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP study conducted according to OECD guideline 401. Klimisch 2. The available information comprises an adequate , reliable (Klimish score 2) study, which is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5 of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Quality of whole database:

GLP study conducted accroding to OECD guideline 402. Klimisch 2.

Additional information

The acute oral toxicity study was conducted in accordance with OECD guideline 401 and EU Method B1, the study was to GLP standard. The registration substance has an LD50 of greater than 2000 mg/kg bodyweight, with only a single treatment related death observed during the study.

The acute dermal toxicity study was conducted in accordance with OECD guideline 402 and to GLP standard. The registration substance had an LD50 of greater than 500 mg/kg bodyweight, this was the maximum concentration tested in the study due to the corrosive nature of the substance. It is considered that the LD50 is greater than 1000 mg/kg bodyweight as no deaths were observed at 500 mg/kg bodyweight and toxicity was limited to severe dermal irritation at the application site. However due to the corrosive nature of the registration substance it can not be said with confidence that the LD50 would be greater than 2000 mg/kg bodyweight. This assessment is used to aid in the classification and labelling of the registration for acute dermal toxicity.

In accordance with Column 2 of Annex VIII, section 8.5.2 of the REACH Regulation, a study of the acute inhalation toxicity is not required, since studies of acute toxicity via oral exposure and via dermal exposure have been provided. Furthermore this is not considered a relevant route of exposure based on the physical-chemical properties of the registration substance. EC 424-820-7 is a liquid with negligible vapour pressure (0.511 Pa at 23 °C). The use of the substance is not anticipated to result in the formation of aerosols, particles or droplets of inhalable size. Thus, exposure of humans via inhalation is unlikely. Therefore, testing for acute toxicity by the inhalation route is not appropriate and should be avoided for reasons of animal welfare.

Justification for selection of acute toxicity – oral endpoint
Key Study: Klimisch 2. The reliable GLP compliant OECD guideline study was chosen.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2, section 8.5.2 of Annex VIII of the REACH Regulation, a study of the acute inhalation toxicity of the test substance is not required, since studies of the acute toxicity of the test substance via oral exposure and via dermal exposure have been provided (see Sections 7.2.1 and 7.2.3 of the IUCLID dossier).

Justification for selection of acute toxicity – dermal endpoint
Key Study: Klimisch 2. The reliable GLP compliant OECD guideline study was chosen. The available information comprises an adequate, reliable (Klimish score 1) study, which is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5 of Regulation (EC) No. 1907/2006.

Justification for classification or non-classification

The acute oral toxicity study was conducted in accordance with OECD guideline 401 and to GLP standard. The registration material had an LD50 of greater than 2000 mg/kg body weight, with only one treatment related death observed during the study. Therefore the registration material does not require classification for acute oral toxicity under Regulation (EC) No 1272/2008 (CLP).

The acute dermal toxicity study was conducted in accordance with OECD guideline 402 and to GLP standard. The registration material had an LD50 of greater than 500 mg/kg bodyweight, this was the maximum concentration tested in the study due to the corrosive nature of the material. It is considered that the LD50 is greater than 1000 mg/kg bodyweight as no deaths were observed at 500 mg/kg bodyweight and toxicity was limited to severe dermal irritation at the application site. However due to the corrosive nature of the registration material it can not be said with confidence that the LD50 would be greater than 2000 mg/kg bodyweight. Therefore in accordance with Regulation (EC) No 1272/2008, the material will be classified as H312: Harmful in contact with skin.