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Diss Factsheets

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:
1-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-2-ol; 2-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-1-ol
EC Number:
807-586-4
Cas Number:
634602-80-5
Molecular formula:
Unspecified
IUPAC Name:
1-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-2-ol; 2-(2-hydroxyethoxy)-3-[4-(2-methyloctyl)phenoxy]propan-1-ol

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- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum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:
other: 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
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