Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited details; no COA; non-GLP. Needs test article id statement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1077

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Cyclohexanone, peroxide
EC Number:
235-527-7
EC Name:
Cyclohexanone, peroxide
Cas Number:
12262-58-7
Molecular formula:
UVCB (equilibrium mixture of a number of cyclohexyl based organic peroxides, hydrogen peroxide, cyclohexanone and water)
IUPAC Name:
Peroxycyclohexanone
Constituent 2
Reference substance name:
Cyclonox LE
IUPAC Name:
Cyclonox LE
Test material form:
other: colorless liquid
Details on test material:
A 2 L sample of the test material was received from the
principal on 13th June 1977. It was a clear colourless
liquid, designated Cyclonox LE-50.

The purity was not provided. However, it is assumed to be 21% based on the information provided in another acute report, conducted during the same time frame, at the same laboratory.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult albino rats (Wistar-derived) from the Institute's colony were used. The body weights of males varied from 247 to 345 g, those of females from 146 to 249 g. The rats were housed in groups of five in screen-bottomed stainless steel cages in a well-ventilated room, maintained at 23-25 degs C. Before dosing the rats were fasted overnight.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
After some preliminary observations, the test material was given by gavage as a 10 % (v/v) dilution in propylene glycol to groups of five males and five females in single doses of 6.94, 8.33, 10.0 or 12.0 ml per kg body weight. After treatment the rats received stock diet and tap water ad
libitum. They were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors.
Doses:
0.96, 0.83, 1.00, 1.2 ml/kg test material
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
The LD50 was calculated according to the method of Weil (Biometrics 8 (l952) 249-263).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1.08 mL/kg bw
Based on:
test mat.
95% CL:
>= 1.02 - <= 1.15
Mortality:
See table.
Clinical signs:
Within a few hours after dosing the rats showed sluggishness and humpback behaviour. Unconsciousness was frequently observed and preceded death. Deaths occurred between 7 and 23 hours after treatment. Thereafter, the survivors recovered gradually and looked
healthy again at the end of the observation period.
Body weight:
No data.
Gross pathology:
Macroscopic examination of the survivors revealed no treatment-related gross alterations.

Any other information on results incl. tables

The density is 1.15.

The LD50 was calculated to be 1.08 ml per kg body weight which corresponds to 1242 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
From the mortality figures the LD50 was calculated to be 1.08 ml per kg body weight with 1.02 and 1.15 as the 95 % confidence limits.
Executive summary:

The acute LD50 was determined following the oral gavage administration of the test substance to groups of five males and five females in single doses of 6.94, 8.33, 10.0 or 12.0 ml per kg body weight. Animals were observed for 14 days following administration for clinical signs of toxicity and mortality. The LD50 was calculated to be 1.08 ml per kg body weight with 1.02 and 1.15 as the 95 % confidence limits.