Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Dec - 31 Dec 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (purity of test substance not specified).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 12. May, 1981
Deviations:
yes
Remarks:
purity of test substance not given
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): T-4113
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI, USA
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 240 - 299 g
- Fasting period before study: 17 to 20 hours (over night)
- Housing: separated by sex in groups of 5 in screen-bottom stainless steel cages (heavy gauge)
- Diet: Purina Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 21 - 31
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 Dec To 31 Dec 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: vehicle was chosen due to good solubility of test substance in this vehicle

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
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: Each animal was observed for clinical signs and mortality at 1, 2.5 and 4 hours following administration, and daily thereafter for 14 days, once daily for clinical signs and twice daily for mortality, weighing was done just before dosing, on day 7 and at study termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Average body weights were calculated.

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 were observed during the study period.
Clinical signs:
1 male animal had diarrhea 4 hours after administration. 2 male animals had miosis starting at 2.5 hours following administration until day 1 and day 2, respectively. Some female animals showed miosis (1, 2.5 and 4 hours after administration and on day 1), diarrhea (1, 2.5 and 4 hours post administration), hypoactivity and lacrimation (2.5 and 4 hours post administration) and hypersensitivity to touch (one animal 4 hours after administration).
Body weight:
Body weight gain during the study was normal.
Gross pathology:
One female animal had multiple red pinpoint foci in the right salivary gland and diffusely dark red submandibular bilateral lymph nodes. A second female had an enlarged pelvis in the right kidney. The findings in the two female rats were considered to be incidental and unrelated to exposure. All other animals were without visible lesions.

Any other information on results incl. tables

Table 1: Clinical Signs (Number of animals affected)

  Hours         Days      
   1.0  2.5  4.0  1  ...  14
 Males (5.0 g/kg)
Appeared Normal  3  2  4  ...  5
 Diarrhea 0  0  1  0  ...  0
 Miosis 0  2  2  1  ...  0
 Females (5.0 g/kg)
 Appeared Normal  2  0  0  4  ...  5
 Miosis  2  3  3  1  ...  0
 Diarrhea  2  3  4  0  ...  0
 Hypoactivity  0  1  2  0  ...  0
 Lacrimation  0  3  3  0  ...  0
 Hypersensitivity to touch  0  0  1  0  ...  0

Table 2: Average body weights (g)

   Dose Level  Average Body Weights (g)      
   (g/kg)  Initial  Day7  Terminal
 Male  5.0  280  344  367
 Female  5.0  253  279  288

Applicant's summary and conclusion

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