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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-09-28 to 1984-10-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Complete guideline conform study report available. Study is performed under GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
single dose: 5000 mg/kg bw
No. of animals per sex per dose:
5 /sex/group
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the 14 day observation period
Clinical signs:
Immediate after application of the test substance the following signs of toxicity were obeserved:
Hypoactivity, crouch and scrubby fur. The day after treatment no signs of toxicity were observed.
Body weight:
No effect on body weight were observed.
Gross pathology:
No macroscopical visible effects were observed.
Other findings:
No other findings.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of above mentioned study, the median lethal dose (LD50) of the test substance after single oral administration to male and female Wistar rats observed over a period of 14 days is 5000 mg/kg bw.
Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered once per oral gavage as a solution in 12.5% sesame oil in Wistar rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as EU Method B.1 (Acute Toxicity (Oral)).

Ten fasted animals (five per sex) were given a single oral dose of test material at the dose level of 5000 mg/kg bw. No mortality occurred. Immediate after application of the test substance the following signs of toxicity as hypoactivity, crouch and scrubby fur were observed. No clinical signs were observed the day after the treatment and during the observation period of 14 days. No effect on body weight development was observed. At the end of the observation period all rats were sacrificed with CO2 gas. Gross pathological examination dit not reveal any alteration.

Based on the results of above mentioned study the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
A valid GLP compliant study is available which was performed in accordance to OECD 401.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

To assess the acute oral toxicity a valid GLP compliant study is available which was performed in accordance to OECD 401. The LD50 oral of the test substance is determined to be greater 5000 mg/mL in Wistar male and female rats.

No study on acute inhalation toxicity is available. Inhalation of registered substance is unlikely due to the following reason: The vapour pressure of the registered substance is 1x10-6Pa (at 20°C). During manufacturing and processing inhalation exposure is unlikely due to efficient control measures in place.

No study on acute dermal toxicity is available. Even when the test substance would be absorbed through the skin, due to the demonstrated low toxicity of the test item it would be of no concern. Further, the test substance is not a skin irritant and not a sensitizer.


Justification for selection of acute toxicity – oral endpoint
Complete guideline conform study report available. Study is performed under GLP.

Justification for classification or non-classification

Based on the available data no classification for acute toxicity is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).