Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Jul - 11 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted in 2002
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

Test animals

Species:
rat
Strain:
other: Wistar Crl:WI (Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 167 - 198 g
- Fasting period before study: animals were fasted overnight prior to dosing and until 3 - 4 h after administration of the test item
- Housing: animals were housed in groups of 3 per cage in labelled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6.36 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Two groups of 3 females each
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/viability was recorded twice daily, clinical examination was made several times on the day of dosing and once daily thereafter, weighing was performed prior to application and weekly thereafter
- Necropsy of survivors performed: yes (at the end of the observation period)
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: according to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg bw
Mortality:
1/6 females was found dead on Day 3 of the study period.
Clinical signs:
Hunched posture and/or piloerection were noted for the animals between Days 1 and 3. Additionally, lethargy, flat posture, slow breathing, shallow respiration and hypothermia were noted for the animal found dead on Days 1 and/or 2.
Body weight:
The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
Gross pathology:
No toxicologically relevant abnormalities were found at macroscopic examination of the animals.

Any other information on results incl. tables

Table 1: Summary of mortality/clinical signs in female rats

Dose [mg/kg bw]

Mortality

Clinical signs

N*

N*

2000

1/6

6/6

*N= Number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
In this acute oral toxicity study in female rats a LD50 value greater than 2000 mg/kg bw was determined.