Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-07-14 to 2014-08-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Light brown viscous liquid
Details on test material:
- Physical state: Light brown viscous liquid
- Analytical purity: 100 %
- Expiration date of the lot/batch: 06 June 2016
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 12 weeks
- Weight at study initiation: 147 - 177 g
- Fasting period during the study: Animals were fasted for overnight period before test item administration and for approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2014-07-14 to 2014-08-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
SPECIFIC GRAVITY OF TEST ITEM: 0.893

MAXIMUM DOSE VOLUME APPLIED: 2.24 mL/kg bw
Doses:
2000 mg/kg
No. of animals per sex per dose:
- Sighting test: 1 female/dose
- Main test: 4 females/dose
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations were made 0.5, 1, 2, and 4 h after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily.
- Frequency of weighing: Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes; at the end of the observation period the animals were killed by cervical dislocation and were subjected to a macroscopic examination.
Statistics:
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.

Results and discussion

Preliminary study:
- No mortality or signs of systemic toxicity were noted during the observation period.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were observed at necropsy.
Other findings:
None

Any other information on results incl. tables

Individual body weights and body weight changes:

Dose level mg/kg

Animal number and sex

Body weight (g) at Day

Body weight gain (g) during week

0

7

14

1

2

2000

1-0

177

198

203

21

5

2-1

148

172

186

24

14

2-2

149

166

180

17

14

2-3

150

176

189

26

13

2-4

147

167

177

20

10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the oral LD50 is higher than 2000 mg/kg bw in rats, therefore the substance is not classified according to CLP Regulation (EC) No. 1272 /2008.
Executive summary:

Test Guidance

OECD Guideline 420 and EC Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Method and materials

Following a sighting study at the dose level of 2000 mg/kg bw, an addition 4 fasted female Wistar rats (RccHan™:WIST) were given a single oral (gavage) dose of the test material at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

Results

No mortality was observed. No signs of systemic toxicity were noted during the observation period. All animals showed expected gains in body weight over the observation period. No abnormalities were observed at necropsy. In this study, the oral LD50 of the test item was considered to be higher than 2000 mg/kg bw in female rats.

Conclusion

Under the test conditions, the oral meadian LD50 is higher than 2000 mg/kg bw in female rats, therefore the substance is not classified according to CLP Regulation (EC) No. 1272 /2008.