Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 July 2012 to 2 August 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP 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 the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF, 12 Nohsan, Notification No. 8147, 2011; including the most recent partial revisions
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Appearance: dark brown viscous liquid
- Storage conditions: room temperature in the dark
- Stability under storage conditions: stable

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl:WI (Han) (outbred, SPF-Quality).
- Age at study initiation: Approximately 9 weeks old.
- Weight at study initiation: 163 to 176 g on the first day of the test. Bodyweight variation did not exceed ± 20 % of the sex mean.
- Fasting period before study: Yes. Animals were deprived of food overnight prior to dosing and until 3 to 4 hours after administration of the test material.
- Housing: Group housing of 3 animals per cage in labelled cages containing sterilised sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 °C.
- Humidity (%): 40 to 70 %.
- Air changes (per hr): Approximately 15 room air changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle.

IN-LIFE DATES: From: 17 July 2012 To: 2 August 2012

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.00 mL/kg bodyweight.
Density of the test material was 1 g/cm³. Therefore the dose volume was calculated as dose level (g/kg) / density (g/mL).
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
6 female animals; dosed in two groups of 3.
Control animals:
no
Details on study design:
The test material was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed for mortality/viability twice daily. Animals were weighed on day 1 (prior to dosing) and on days 8 and 15.
At periodic intervals on the day of dosing and once daily thereafter clinical signs were noted. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: Yes. At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure. Descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality.
Clinical signs:
Hunched posture was exhibited by two animals on day 1 of the study.
Body weight:
The bodyweight gain shown by the animals over the study period was considered to be similar to that expected of normal, untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the oral LD50 of the test material was established to be >2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.
Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF 12 Nohsan, Notification No. 8147.

The undiluted test material was administered by gavage to two subsequent groups of three female Wistar rats at a dose level of 2000 mg/kg. The animals were observed for 15 days before being subjected to necropsy.

No mortality was seen throughout the study; clinical signs included two animals showing hunched posture on day 1 after dosing. Bodyweight gains were considered to be normal and no macroscopic abnormalities were observed at necropsy.

Under the conditions of this study, the oral LD50 of the test material was established to be >2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.