Registration Dossier

Administrative data

Description of key information

A key oral acute toxicity study according to OECD 401 test method was performed in male rats, leading to a LD50 =4650 mg test mat./kg bw. A key dermal acute toxicity study according to OECD 402 test method was performed in male rabbits, demonstrating a LD50 > 2500 mg test mat./kg bw. Acute inhalation toxicity was waived based on exposure reasons.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 650 mg/kg bw
Quality of whole database:
Reliable

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw
Quality of whole database:
Reliable

Additional information

Acute oral toxicity

In a key acute oral toxicity study (Shaffer et al., 1957a) the test item was administered to groups of young, male albino rats (5 animals per group) as an 20% aqueous solution at dosages of 1250, 2500, 5000 and 10000 mg active ingredient/kg bw. Death occurred fairly promptly following lethal doses, usually within one-half to one hour, and post-mortem examination revealed moderate to severe hemorrhage of the entire gastrointestinal tract. From the number and distribution of deaths, the LD50 is calculated as 4650 mg/kg bw. Survivors exhibited varying degrees of depression for periods up to 24 hours following the dose, but thereafter maintained a normal appearance and behavior for remainder of a 7-day observation period. Gross autopsy disclosed no pathology that could be attributed to the dose.

In conclusion, based on the registered substance, there is no acute oral toxicity hazard as LD50 is >2000 mg/kg bw (active ingredient).

Acute dermal toxicity

In a key acute dermal toxicity study (Shaffer et al., 1957a) three groups of male albino rabbits, 5 animals per group, received single applications of the test item on the closely-clipped skin of the abdomen at dosages of 2500, 5000 and 10000 mg active ingredient/kg bw, respectively. The dose was moistened with sufficient water to form a paste, and retained in contact with the skin for 24 hours by means of a cuff of polyethylene film which was encircled the trunk of the animal. Moderate to severe erythema and edema were present in all cases but edema was greatly reduced by the second day after dosing, and has subsided almost completely by the third day. Erythema persisted to a slight degree a day or two longer. Apart from varying degrees of depression, most animals gave no evidence of systemic toxicity on the day following that of application of the dose. There were two deaths in the 10000 mg/kg group, and one death at the 5000 mg/kg level. LD50 was greater than 2500 mg/kg bw. Survivors’ results, were observed for a total of seven days after that of the dose, and were than sacrificed. No significant pathology was find by gross autopsy.

In conclusion, there is no acute dermal toxicity hazard as LD50 is >2000 mg/kg bw (active ingredient). Further information supporting the absence of acute toxicity potential is provided in the read across justification for the Di-ester category, showing that all substances in the group were negative for acute dermal toxicity (justification with data matrix separately attached in Section 13). 

Acute inhalation toxicity

The registered substance has a vapour pressure of 25 Pa (20°C) and is marketed only in non solid and non granular form, i.e., as liquid. Inhalation is unlikely and acute inhalation testing would not lead to better risk assessment, therefore the study was waived based on Column 2 (Paragraph 8.5.2) in REACH legislation 2006R1907 Annex VIII.


Justification for selection of acute toxicity – oral endpoint
Key studty

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

As LD50 values were above limit dose of 2000 mg/kg bw for oral and dermal application, classifiation is not warranted according to CLP and DSD.