Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4.11.-18.11.1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP (performed 1982), comparable to OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Measured for Batch: Density 0.976 g/ml; refraction index (20°C) = 1.571; nitrogen content 4.6%; further components quantified by gas chromatography
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tiertarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 170-221 g
- Fasting period before study: overnight prior to dosing
- Housing: 5 animals per Macrolon cage type 3 with standardized soft wood bedding (Societe Parisienne dessciures, Pantin)
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
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 observation: Mortality: daily, a.m. and p.m. on working days. Clinical signs: daily. Body weight: on days 1, 7, 14, and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: sedation, dyspnea, exophtalmus, ruffled fur, and curved body position; body weight
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred.
Mortality:
No mortality occurred.
Clinical signs:
The animals recovered within 13 days.
Body weight:
Group means (g)/standard deviations
Males: day 1, 203/10.9; day 7, 257/15.8; day 14, 303/19.0
Females: day 1, 186/9.6; day 7, 211/11.0; day 14, 224/12.4
Gross pathology:
No compound related gross organ changes were observed.

Any other information on results incl. tables

SIGNS AND SYMPTOMS

 Observations Exposure day: hours   Days of post-exposure period                                                     
   1  2  3  5  1  2  3  4  5  6  7  8  9  10  11  12  13  >13
 5000mg/kg                                                         
 sedation  xx  xx  xx  xx                            
 dyspnoea  x  x  x  x  x  x  x  x  x  x  x  x  x  x        
 exophtalmus  x  x  x  x  x  x  x  x  x  x  x  x  x  x  x  x    
ruffled fur   xx  xx  xx  xx  xx  x  x  x  x  x  x  x  x  x  x      
 body position-curved  x  x  x  xx  x  x  x  x  x  x                

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CAS 68411-46-1 did not cause mortality when administered orally at a single dose of 5000 mg/kg bw to the albino rat.