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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1989 - January 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
other: Notification issued "Concerning Testing Facilities Stipulated in Article 4 of the Order Prescribing the Items of the Tests Relating to New Chemical substances"
Version / remarks:
Notification No. 233 of the Planning and Coordination Bureau, Environment Agency; No. 38 of the Pharmaceutical Affairs Bureau, Ministry of Health and Welfare; and No. 823 (1988) of the Basic Industries Bureau, Ministry of International Trade and Industry, November 18, 1988
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene
EC Number:
406-550-1
EC Name:
A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene
IUPAC Name:
Reaction mass (1:2:1) of bis(N-cyclohexyl-N'-phenyleneureido)methylene and bis(N-octadecyl-N'-phenyleneureido)methylene and bis(N-dicyclohexyl-N'-phenyleneureido)methylene
Test material form:
solid: particulate/powder
Details on test material:
Description: White yellowish solid
Test substance storage: At room temperature in the dark

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Charles River Japan, Inc..
- Age at study initiation: Young adult animals (approx. 4 weeks old)
- Weight at study initiation: Males 120 to 131 gram; Females 104 to 116 gram.
- Fasting period before study: 17 h
- Housing: Group housing of 5 animals per cage in labeled metallic bracket cages.
- Diet: Free access to pelleted rodent diet (MF, Lot Nos. 89-09, 89-10, Oriental Yeast Co., Ltd.).
- Water: Free access to tap water.
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
set to maintain
- Temperature (°C): 20 – 26
- Humidity (%): 40 - 70
- Air changes (per hr): 11 - 18
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 November 1989 to 29 November 1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
GAVAGE METHOD: metallic stomach probe.

Frequency: single dosage, on Day 1.

VEHICLE: cornoil
- Justification for choice of vehicle: Vehicle was chosen for its nontoxicity in animals.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.

DOSAGE PREPARATION:
A sample of the test substance was extracted, weighed, and suspended in corn oil with a mortar.
Doses:
2000 mg/kg bw

No. of animals per sex per dose:
10 rats per sex per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weights: prior to dosing (day 0), at Day 3, 7, and 10, and terminally (day 14).
Clinical signs: 10, 20, and 30 minutes after dosing; 1, 2, 3, 4, 5, and 6 h after dosing; and daily for the remainder of the 14- day test period.
- Necropsy of survivors performed: all animals at the end of the study
- Other examinations performed: none.
Statistics:
No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Preliminary study:
3 male and 3 female 5-week-old rats were dosed with 2000 mg/kg bw. No death were observed.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
Diarrhea observed in 4 amles and 2 females in the control group 1 h after administration which recovered within 1 h.
Body weight:
The mean body weight gain shown by the treated animals over the study period was considered to be similar to the control group.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to Regulation (EC) No. 1272/2008.
Conclusions:
In an acute oral toxicity study with male and female rats an LD50 >2000 mg/kg bw was determined.
Executive summary:

ODA-MDI-CHA 6-part blend was evaluated for acute oral toxicity in five-week old male and female Crj:CD(SD) rats at a dose level of 2000 mg/kg bw in corn oil. No death occured in rats of either sex, and no abnormalities were detected either in the clinical signs and body weight changes during the study period or in autopsy findings at the end of the study period. It was concluded that the LD50 value of the test substance was >2000 mg/kg bw in male and female rats.

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