Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
QUALITY ASSURANCE ATTESTATION, G.L.P. COMPLIANCE STATEMENT & GLP certificates included in the full report. The study was conducted according to an internationally recognised method, and under GLP. No deviation was reported. The substance is adequately characterised. Therefore full validation applies.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
test method B.1tris of the directive 2004/73/EC
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6,8-dimethylnon-7-enal
EC Number:
486-670-9
Cas Number:
899810-84-5
Molecular formula:
C11H20O
IUPAC Name:
6,8-dimethylnon-7-enal
Test material form:
other: liquid
Details on test material:
• Form : liquid
• Colour : colorless
• Batch n° : 862036
• Storage : room temperature
• Production date: September 2007 • Expiry date: September 2008
• Purity/Concentration: 97.79%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Twelve Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
– France), were used after an acclimatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 180 g and 208 g and were 8 weeks old.
Three healthy female rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel
mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage
was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 19 °C and 25 °C
- relative humidity : between 31% and 70%
- lighting time: 12 hours daily

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Distilled water
Details on oral exposure:
Administered by gavage using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
The animals of Group 2, received an effective dose of 2000 mg/kg body weight of the test item
Noreenal A45756, administered under a volume of 2.34 mL/kg body weight
The animals of Group 1, received, according to the same experimental conditions, the control item
(distilled water) under a volume of 2 mL/kg body weight.
No. of animals per sex per dose:
Twelve Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
– France), were used after an acclimatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 180 g and 208 g and were 8 weeks old.
Group 1 (control): 6 female rats Rf9869 to Rf9874
Group 2 (treated – 2000 mg/kg): 3 female rats Rf9878 to Rf9880
3 female rats Rf9887 to Rf9889
Control animals:
yes
Details on study design:
Daily examination of the animals
Systematic examinations were carried out to identify any behavioural or toxic effects on the major
physiological functions 14 days after administration of the test item.
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the
observation sheet.
These observations were compared to control data.
Observations and a mortality report were then carried out every day for 14 days.

Periodical examinations of the animals
The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and
D14.
Weight changes were calculated and recorded.

Examination at the end of the test
On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to
fatal levels. Macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting
macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
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.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between
treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
According to the EU criteria for classification, packaging and labelling of hazardous substances and
mitures, the test item is not considered as hazardous for this endpoint and doesn't need to be classified.
Executive summary:

The test item was administered by oral route to a group of 6 female Sprague

Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established

on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated December 17th,

2001 and the test method B.1tris of the Directive N° 2004/73/EC.

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.

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by

oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and

preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item

needs not to be classified. No symbol and risk phrase are required.

Categories Display