Registration Dossier

Administrative data

Description of key information

In order to assess the acute oral toxicity a valid study is available which was performed in accordance to OECD 401.
Inhalation of registered substance is unlikely due to the following reason: The vapour pressure of the registered substance is low with less than 0.001 Pa (at 20°C). During manufacturing and processing inhalation exposure is unlikely due to efficient control measures in place. Even when inhalation occurs in humans the substance will deposit within the nasal cavity onto the epithelium where it will be either metabolized or at the end will be swallowed. As the test substance is considered to be of low acute and systemic toxicity, no toxic effects are expected after inhalation. Thus no study on acute inhalation toxicity is performed.
No study on acute dermal toxicity is available. Absorption via dermal exposure of the test substance is unlikely due to the following reason: The manufacture is performed in closed systems. Even when absorbed through the skin, due to the demonstrated low systemic toxicity of the test item it would be of no concern. Further, the test substance is not a skin irritant or sensitizer.

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:
1984-10-18 to 1984-11-01
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:
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:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
No reduction in body weight gain.
Gross pathology:
No effect visible.
Other findings:
none
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 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 25% 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. No clinical signs were observed 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:
Reliability 1

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

In order to assess the acute oral toxicity of the test substance a valid study is available which was performed in accordance to OECD 401.

Inhalation of registered substance is unlikely due to the following reason: The vapour pressure of the registered substance is low with less than 0.001 Pa (at 20°C). During manufacturing and processing inhalation exposure is unlikely due to efficient control measures in place. Even when inhalation occurs in humans the substance will deposit within the nasal cavity onto the epithelium where it will be either metabolized or at the end will be swallowed. As the test substance is considered to be of low acute and systemic toxicity, no toxic effects are expected after inhalation. Thus no study on acute inhalation toxicity is performed.

No study on acute dermal toxicity is available. Absorption via dermal exposure of the test substance is unlikely due to the following reason: The manufacture is performed in closed systems. Even when absorbed through the skin, due to the demonstrated low systemic toxicity of the test item it would be of no concern. Further, the test substance is not a skin irritant or sensitizer.


Justification for selection of acute toxicity – oral endpoint
To assess the acute oral toxicity a valid GLP compliant study is available which was performed in accordance to OECD 401.

Justification for classification or non-classification

Based on the available data no classification 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).