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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-03-24 till 1999-04-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD 401)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: colorless liquid
- Analytical purity: 99.4%
- Expiration date of the lot/batch: 1999/07
- Storage condition of test material: stored in dark at RT
-Batch 9807016 filling 41/99

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, L`Arbresle, France
- Age at study initiation: appr. 6 weeks
- Weight at study initiation: 174 +/-7g (males) 135+/-5g females
- Fasting period before study: appr. 18 h (acess to water)
- Housing: sex-separated in groups on dust-free sawdust in polcarbonate cages
- Diet / Water (e.g. ad libitum): ad lib. except for fasting
- Acclimation period: >5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
10 ml/ kg BW
Doses:
2000 mg/kg BW
No. of animals per sex per dose:
5
Control animals:
other: historical control
Details on study design:
no
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
Animals were observed for clinical signs and mortality frequently on the day of application, and afterwards once a day for 15 days;none during the whole study.
Clinical signs:
Animals were observed for clinical signs and mortality frequently on the day of application, and afterwards once a day for 15 days; hypoactivity and piloerection in one male and one female on day 1 only; no effect on other animals.
Body weight:
body weight recorded on day 1, day 8 and day 15 ; slight body weight loss in one female, while all other animals gained weight.
see table 1
Gross pathology:
on day 15: no apparent abnormalities.
Other findings:
no

Any other information on results incl. tables

Table 1: Mean bodyweights (BW)

 

historical control

study

(2000 mg/kg bw)

MALES Initial BW

182

174

 MALES BW day 15   315   295
 FEMALES Initial BW   147   135
 FEMALES BW day 15   215   193

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
According to GHS criteria, no classification of ACIDE UNDECYLENIQUE is required
Executive summary:

The acute oral toxicity of the test substance ACIDE UNDECYLENIQUE was evaluated in rats according to OECD guideline No. 401 and EU directive 92/69/EEC B.1. The substance was applied to ten (five male and 5 female) Sprague-Dawley rats at a dose of 2000 mg/kg bw. Animals were observed for 15 days. Transient clinical signs (hypoactivity and piloerection) were present in two out of ten animals on the day of treatment only. Mortality, reduction of body weight gain and abnormalities in gross pathology were not evident.

Under the experimental conditions, the dermal LD0 of the test substance ACIDE UNDECYLENIQUE is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.