Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 16, 2012 - November 15, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Version / remarks:
(2001)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(2008)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Catalysed Reaction Products of 3,7-dimethyl-2,6-octadienal in the presence of ethanol
IUPAC Name:
Acid Catalysed Reaction Products of 3,7-dimethyl-2,6-octadienal in the presence of ethanol
Test material form:
liquid
Specific details on test material used for the study:
Identification: Citrathal
Description: Clear yellow liquid
Batch: SC00005944
Storage conditions: room temperature in the dark

Test animals

Species:
rat
Strain:
other: Wistar (RccHan:WIST)
Sex:
female
Details on test animals or test system and environmental conditions:
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 154-176 g
- Fasting period before study: overnight before dosing
- Housing: Group housing of 3 animals per cage in suspended solid-floor polypropylene cages
- Diet: Free access (2014C Teklad Global Rodent diet, Harlan Laboratories UK Ltd.)
- Water: Free access to tap water
- 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:
GAVAGE METHOD: metal cannula attached to a graduated syringe
Frequency: single dosage, on Day 1.

DOSE VOLUME APPLIED: 2.18 mL/kg body weight
Doses:
2000 mg/kg body weight

No. of animals per sex per dose:
6 (2 groups of three females in a stepwise manner)
Control animals:
no
Details on study design:
- Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality and Clinical signs: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily
Body weights: prior to dosing and 7 and 14 days thereafter
- 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.
Remarks on result:
other: No mortalities and no clinical signs of toxicity occurred
Mortality:
No mortalities occurred
Clinical signs:
No clinical signs of toxicity occurred
Body weight:
No abnormalities were observed
Gross pathology:
No abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in female rats, conducted in accordance with OECD 423 (2001) and according to GLP principles, a LD50 oral of >2000 mg/kg bw was determined.
Executive summary:

The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008) and according to GLP principles. The substance was dosed (undiluted) at 2 g/kg bw in 6 female rats, in 2 steps. No mortality and no clinical signs of toxicity occurred. Macroscopic examination of the animals did not reveal any abnormalities. The acute oral toxicity (LD50) was determined to be >2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity by the oral route in accordance with the CLP Regulation.