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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:
24 Jul - 16 Aug 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see “remarks”
Remarks:
GLP-Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Justification for type of information:
refer to analogue justification provided in IUCLID section 13

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
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
147256-33-5
EC Number:
604-580-1
Cas Number:
147256-33-5
IUPAC Name:
147256-33-5

Test animals

Species:
rat
Strain:
other: Wistar (RccHanTM:WIST)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 146-166 g (first group) and 157-163 g (second group)
- Fasting period before study: animals were fasted overnight immediately before the day of dosing and for approx. 3 to 4 h after dosing.
- Housing: animals were housed in groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes and environmental enrichment items.
- Diet: 2014C Teklad Global Diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- 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: 2.18 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: based on available information on the toxicity of the test item, 2000 mg/kg bw was chosen as the starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortalities and overt signs of toxicity 30 min, 1, 2 and 4 h after dosing and subsequently once daily during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 experimental
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
No mortalities were observed during the study period.
Clinical signs:
No signs of systemic toxicity were noted during the 14-day observation period.
Body weight:
All animals showed the expected gains in body weight over the study period.
Gross pathology:
At gross pathology, no abnormalities were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified