Registration Dossier

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other: GLP compliant guideline study, available as unpublished report, no restriction, fully adequate for assesment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay Labor fur biologische Analytik GmbH, INF 515, 69120 Heidelberg
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: 2-Chlor-1-(3-hydroxyphenyl)-ethanol
- Physical state: Solid
- Homogeneity: The test substance was homogeneous by visual inspection
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: ca 10 weeks
- Weight at study initiation: 300 mg/kg bw group: 173.0g±6.08; 2000 mg/kg bw group 1: 171.7g±4.93; 2000 mg/kg bw group 2: 175.7g±9.45;
- Fasting period before study: at least 16 hours
- Housing: Single housing in Makrolon cages, type III.
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 20- 24
- Humidity (%): 20- 80
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6 and 40 g/100 mL
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: Good homogeneity in olive oil Ph.Eur.
- Form of administration: suspension

DOSAGE PREPARATION: For better handling the test substance was ground with mortar and pistil. The test-substance preparation was produced for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
300 mg/kg: 3; 2000 mg/kg: 6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weight determination shortly before administration (day 0), weekly thereafter and an the last day of observation. Recording of signs and symptoms 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 animal was made twice each workday and once on weekends and on public holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in the six females administered with 2000 mg/kg bw and in the three females administered with 300 mg/kg bw.
Clinical signs:
Clinical Observation in the 2000 mg/kg test groups revealed impaired and poor general state, dyspnoea, piloerection, none and reduced feces, staggering, ataxia, chromodacryorrhea, lacrimation and smeared fur from hour 0 through to study day 3 after administration.
No clinical signs and findings were observed in the 300 mg/kg bw administration group.
Body weight:
The mean body weight of the test groups increased throughout the study period.
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
Conclusions:
Under the conditions of this study the oral LD50 in rats is > 2000 mg/kg bw.
Executive summary:

In an acute toxic class method (OECD 423 guideline study, GLP) the test substance was administered to female Wistar rats oral gavage. One group of three female rats were exposed to 300 mg/kg bw followed by two groups of three female rats exposed to 2000 mg/kg bw. After an observation period of 14 days surviving animals were necropsied. No mortality was observed in all exposed animals. Impaired and poor general state, dyspnoea, piloerection, none and reduced feces, staggering, ataxia, chromodacryorrhea, lacrimation and smeared fur were observed in the 2000 mg/kg bw dose group. No clinical effects were observed in animals exposed to 300 mg/kg bw. The LD50 was therefore determined to be above 2000 mg/kg bw.