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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 to 31 October 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP study conducted in compliance with OECD Guideline No. 423 without any deviation. The substance is adequately identified, but details on composition are missing. Therefore validation applies with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001.
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Directive n° 2004/73/EC.
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
2007-01-11
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
7-nonenal, 6,8-dimethyl-, (6S)
Cas Number:
899810-99-2
Molecular formula:
C11 H20 O
IUPAC Name:
7-nonenal, 6,8-dimethyl-, (6S)
Constituent 2
Chemical structure
Reference substance name:
7-nonenal, 6,8-dimethyl-,(6R)-
Cas Number:
899810-91-4
Molecular formula:
C11 H20 O
IUPAC Name:
7-nonenal, 6,8-dimethyl-,(6R)-
Test material form:
liquid
Details on test material:
- Physical state: colourless translucent liquid
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 180-208 g
- Housing: housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff, ad libitum except during the treatment period
- Water: tap-water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 31-70%
- Air changes: between ten and fifteen changes per hour.
- Photoperiod: 12 h light/12 h darkness.

IN-LIFE DATES: from 16 to 31 October 2007.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.34 mL/kg bw

ADMINISTRATION OF TEST ITEM:
The animals of Group 2, received an effective dose of 2000 mg/kg body weight of the test item Noreenal A45756, administered by gavage under a volume of 2.34 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females
Control animals:
yes
Remarks:
distilled water
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min, 1, 3 and 4 hours after test item administration and thereafter once daily for 14 days. Animals were weighed pretest (Day 0) and on Day 2, 7 and 14.
- Necropsy of survivors performed: Yes; Animals were killed on Day 14 and subjected to macroscopic examination.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: A decrease of the spontaneous activity (6/6) associated with a piloerection (2/6) at the reading time 4 hours. 24 hours after the test item administration, no clinical signs related to the test item administration were noted.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 > 2000 mg/kg bw. Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

 

No mortality occurred during the study. It was registered from the first hours of the test, a decrease of the spontaneous activity (6/6) associated

with a piloerection (2/6) at the reading time 4 hours. 24 hours after the test item administration, no clinical signs related to the test item administration were noted. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

 

Oral LD50 Female > 2000 mg/kg bw

Under the test conditions, the test material is not classified according to the annex I of the Regulation (EC) No. 1272/2008 and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.