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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study conducted between the 21st February and the 18th April 2013.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Test Item: SE7B Batch 2137-0 (CAS 1365345-64-7)
Stability: Stable
Purity: 100%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Animals were received from Charles River, Raleigh NC, on 31 Jan 2013 and 05 Mar 2013. Following an acclimation period of at least five days, six healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.

The animals were born the 05 Dec 2012 and 07 Jan 2013. The pretest body weight range was 196 - 240 grams. The weight variation of the animals used did not exceed ±20% of the mean weight of the previously dosed animals.

The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.

Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No vehicle was used.

Dosing:
The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to six female rats.
Doses:
3 females were initially dosed at 2000 mg/kg, followed by a further three females.
No. of animals per sex per dose:

6 females dosed at 2000 mg/kg.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. Body weights were recorded immediately pretest, weekly, and at termination. All animals were examined for gross pathology.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
There were no abnormal physical signs observed.
Body weight:
All animals gained body weight by study termination.
Gross pathology:
The gross necropsy of all animals revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No effects were seen during the study on the test material (CAS# 1365345-64-7 (SE7B Batch 2137-0)). The test substance is not classified for acute toxicity according to to CLP.
Executive summary:

Objective:

To determine the potential for oral toxicity using the Acute Toxic Class Determination. This study was designed to comply with the standards set forth in current OECD Guidelines for the Testing of Chemicals, Guideline 423 adopted December 17, 2001. Guideline 423 is referred to in DPPTS 870.1000 as an acceptable method to assess lethality within a dose range. The test article is assigned to a toxic category based on the mortality results and significant clinical signs of toxicity up to the Category 4 value tested according to the current Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

Method Synopsis:

Initially three healthy female Sprague Dawley rats were dosed orally with CAS# 1365345-64-7 (SE7B Batch 2137-0) at 2000 mg/kg. An additional three healthy females were dosed as a confirmatory group at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. Body weights were recorded immediately pretest, weekly, and at termination. All animals were examined for gross pathology. The test article was assigned to a toxic category based on the mortality response noted.

Summary:

All six females survived the single 2000 mg/kg oral dose. There were no abnormal physical signs observed. All animals gained body weight by study termination. The gross necropsy of all animals revealed no observable abnormalities.

Conclusion:

CAS# 1365345-64-7 (SE7B Batch 2137-0) is considered to be in Acute Toxic Category 5, or unclassified. The oral LD50 is greater than 2000 mg/kg in female rats.