Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 May 1986 - 11 June 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Chemical name: Neodecane peroxoic acid 1,1,3,3-tetramethyl butyl ester
- Appearance: Colouless clear liquid
- CAS-reg. no.: 51240-95-0

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, Brussels, Belgium. Date of arrival at the animal house
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: The body weights of the males on day 0 ranged from 304 to 332 g and those of the females from 200 to 247 g.
- Fasting period before study: Feed was withheld overnight before dosing till approximately 4 hours after administration of the test substance
- Housing: individually housed in polycarbonate cages
- Diet (e.g. ad libitum): ad libitum (standard laboratory animal diet (RMH-B, pellet diameter 10 mm))
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 50-95
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 21 May 1986 - 11 June 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
The test substance was administered as a single dose using a stainless steel stomach cannula. Prior to dosing the test substance was removed from storage and was kept on ice until dosing. The dose volume was 5.7 ml/kg body weight. The day of dosing was considered as day 0.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage-side observations were performed on the day of dosing (approximately once every two hours) and daily thereafter. With exception of weekends and holidays a mortality check was performed at the end of the day. Individual body weights (with group means and standard deviation) were measured weekly. At the end of the study (day 14) all surviving animals were sacrificed by CO2-asphyxation and subjected to autopsy.
- Necropsy of survivors performed: yes
- Other examinations performed: None
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred.
Clinical signs:
No signs of systemic toxicity were observed during the 14-day observation period.
Body weight:
Weekly group mean body weight gain was normal. There was no evident sex related effect.
Gross pathology:
Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, received a single oral dose of the test substance 5000 mg/kg body weight. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. Weekly group mean body weight gain was normal. There was no evident sex related effect. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg body weight.