Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 - 26 Dec 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions. Only 5 males were used in the limit test, the observation period was 7 days. no gross pathology examination was performed, the mouse was used instead of the preferred species the rat, the test substance purity was not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
yes
Remarks:
only 5 males were used in the limit test, no gross pathology examination was performed, observation period was 7 days, the mouse was used instead of the preferred species the rat, the test substance purity was not specified
Qualifier:
according to guideline
Guideline:
other: Pharmacopée Franҫaise IXe édition
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Name of test material: undecylenate de glycerol
- Physical state: Pale yellow gel
- Analytical purity: 100%
- Lot/batch No.: 18060502

Test animals

Species:
mouse
Strain:
other: NMRI Han EOPS
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: EVIC CEBA, Blanquefort, France
- Weight at study initiation: on average 20 g
- Fasting period before study: approximately 4 h
- Housing: animals were housed in groups of 5 in polypropylene cages (46.5 x 15.5 x 14 cm)
- Diet: UAR 113 pellets, ad libitum
- Water: tapwater, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: The animals were observed for mortality and clinical signs during 2 hours after administration and twice daily thereafter during the study period; the body weight was recorded prior to administration and on day 7 prior to sacrifice
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified