Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.
Acute dermal toxicity: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The study has been conducted according to standard guidelines and GLP and is adequately reported. The study has been assigned a reliability 1.

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
2 000 mg/kg bw
Quality of whole database:
The study has been conducted according to OECD Guidelines (No. 402) and GLP and is adequately reported. The study has been assigned a reliability 1.

Additional information

Acute oral toxicity

When the test substance was administered orally at one dose level (5000 mg/kg) to one group containing ten rats (5 males and 5 females), no deaths occurred and systemic signs noted were slight ataxia and lethargy (days 0, 3 and 4) in 3 animals and slightly loose faeces (day 0) in one animal.

As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.

Acute dermal toxicity

Method.

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality.

There were no deaths.

Clinical Observations.

There were no signs of systemic toxicity.

Dermal Irritation.

Very slight erythema was noted at the test sites of one male and one female. There were no other signs of dermal irritation noted.

Bodyweight.

All animals showed expected gains in bodyweight over the study period, except for one female which showed,a slight bodyweight loss during the second week.

Necropsy.

No abnormalities were noted at necropsy.

Conclusion.

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

The test item did not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.


Justification for selection of acute toxicity – oral endpoint
The available acute oral toxicity study is assigned as reliability study 1 and is the only acute oral toxicity study available.

Justification for selection of acute toxicity – inhalation endpoint
Refer to data waiver for acute toxicity via the inhalation route.

Justification for selection of acute toxicity – dermal endpoint
The available acute dermal toxicity study is assigned as reliability study 1

Justification for classification or non-classification

The substance does not meet the criteria for classification, under the CLP regulations, for acute toxicity via the oral route based on the result of an acute oral toxicity study conducted, giving a LD50of greater than 5000 mg/kg bodyweight.

The substance does not meet the criteria for classification, under the CLP regulations, for acute toxicity via the dermal route based on the results of an acute dermal toxicity study conducted to OECD Guideline 402, which gave an LD50of greater than 2000 mg /kg bodyweight.