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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD 423)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(December 17, 2001)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
(Bioassay Labor für biologische Analytik GmbH, Heidelberg, Germany)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxirane, [(4-nonylphenoxy)methyl]-, reaction product with ethylene glycol
EC Number:
807-586-4
Cas Number:
634602-80-5
Molecular formula:
Unspecified
IUPAC Name:
Oxirane, [(4-nonylphenoxy)methyl]-, reaction product with ethylene glycol

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: test group 1 (3 female animals): 182.3 +/- 2.89 g (mean); test group 2 (3 female animals): 182.3 +/- 3.06 g (mean);
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: single housing in Makrolon cages, type III
- Diet: VRF1(P), SDS Special Diets Services, Altrip, Germany; ad libitum
- Water: Tap water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): approx. 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: 1.95 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw were administered to another group of 3 female animals in the second step.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 x 3 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of clinical signs several times on the day of administration, and at least once daily thereafter each
workday for the individual animals; a check for any dead or moribund animals was made at least once each workday; individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
Statistics:
Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred. Clinical signs were noted not later than 3 days after administration.
Mortality:
No mortality occurred.
Clinical signs:
In the first test group impaired general state, dyspnoea and piloerection were noted from hour 2 or 3 until hour 5 and on study day 3. In two animals ataxia was observed at hour 2 and persisted in one animal up to hour 3 after administration. Furthermore staggering was noted in two out of three animals at hour 4 and 5. In all animals of this test group reduced feces was observed on study day 1. The animals of the second test group showed impaired general state and piloerection from hour 2 until hour 5. These findings were also noted in two animals on study day 3 after administration. Staggering was observed from hour 2 until hour 3 or 5 in all animals while ataxia was noted in one animal at hour 4 and 5.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU