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Description of key information

oral (rat): > 5000 mg/kg bw (m+f)
dermal (rat): > 2000 mg/kg bw (m+f)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
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
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
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)
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.

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                
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP (performed 1988), only summary report, acceptable because no mortality occured
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Body weight not controlled. No information on housing conditions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Lot/batch No.: EN-127 506.82
Species:
rat
Strain:
other: albino
Sex:
male/female
Type of coverage:
not specified
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred
Mortality:
No mortality was observed.
Clinical signs:
Piloerection, abnormal body positions, and dyspnea were seen, being common symptoms in acute toxicity testing. The animals recovered within 9 days.
Gross pathology:
No adverse findings noted.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance caused no mortality when administered dermally at a single dose of 2000 mg/kg bw to the albino rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

EC 270-128-1 was tested for acute toxicity via oral and dermal application to rats.

Acute oral toxicity:

An LD50 of > 5000 mg/kg bw was identified via oral application for rats. The substance-related symptoms recorded were a slight sedation (for 5 hours), dyspnoea (until day 10), slightly ruffled fur (until day 11), exophthalmus (until day 12), and a curved body position (until day 6). These symptoms are common in acute testing and indicate no special hazard.

Acute dermal toxicity:

EC 270-128-1 is found to be non acute toxic via dermal application. LD50 value of > 2000 mg/kg bw was identified in rats.

Acute inhalation toxicty

Inhalative exposure is no human relevant route of exposure.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of EC 270 -128 -1 with regard to acute toxicity.

EC 270 -128 -1 is not classified for acute toxicity via oral or dermal route in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008.