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Description of key information

The acute oral toxicity study showed mortality at doses > 4640 mg/kg bw. The LD50 is 6231 mg/kg bw.
The acute dermal toxicity study did not show mortality up to 3170 mg/kg bw.

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is pre-GLP and pre-OECD guidelines. The study has been performed according to a method similar to OECD 401
Principles of method if other than guideline:
Pre-guideline study. Three doses suspended in 2% CMC were applied by gavage to each 5 male and 5 female rats. Observation period was 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: raised in-house at Ciba-Geigy Ltd. Switzerland, Sisseln
- Weight at study initiation: 160 to 180 grams
- Fasting period before study: overnight
- Housing: Macrolon cages type 3, groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hours dark, 10 hours light

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
Doses:
4640 mg/kg bw, 6000 mg/kg bw, 7750 mg/kg bw,
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After 1 and 2 hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology of organs
Statistics:
LD50 including 95% confidence limits were calculated with the logit model
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 6 231 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 5 723 - <= 6 957
Mortality:
Animals started to die after 7 days at 6000 mg/kg bw
Animals started to die after 24 hours at 7750 mg/kg bw
Clinical signs:
sedation, dyspnoea, exophtahlmos, curved positiona and ruffled fur
Body weight:
no data
Gross pathology:
no substance-related deviations from normal morphology observed in organs

Dose Died within
mg/kg bw 1 hour 24 hours 48 hours 7 days 14 days
m f m f m f m f m f
4640 5 5 0 0 0 0 0 0 0 0
6000 5 5 0 0 0 0 2 1 2 1
7750 5 5 1 0 2 2 5 5 5 5
 
                   
                     
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 in the rat is about 6200 mg/kg bw and similar in both sexes.
Executive summary:

The LD50 oral in the rat is ca. 6200 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 231 mg/kg bw

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is pre-GLP and pre-OECD guidelines. The study has been performed according to the method of Noakes, D.N. and Sanderson,, D. M: A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26, pp 59-64 (1968). The result of the experiment is considered reliable.
Principles of method if other than guideline:
Pre-guideline study according to Noakes, D.N. and Sanderson,, D. M: A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26, pp 59-64 (1968). Two doses suspended in 2% CMC were applied to the shaved backs of each 5 male and 5 female rats. Observation period was 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: raised in-house at Ciba-Geigy Ltd. Switzerland, Sisseln
- Weight at study initiation: 180 to 200 grams
- Fasting period before study: no
- Housing: Macrolon cages, individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hours dark / 10 hours light
Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on dermal exposure:
TEST SITE
- Area of exposure: 60 cm2
- % coverage:
- Type of wrap if used: "dressing fixed with adhesive elastic bandage"

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2150 mg / kg and 3170 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After 4 hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology of organs
Statistics:
no
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 3 170 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no higher doses tested
Mortality:
none
Clinical signs:
Within 4 hours after treatment the rats in all dosage groups showed syspnoea, curved body position and ruffled fur. No local skin irritation was seen.
The animals recovered from systemic symptoms within 10-12 days.
Body weight:
no data
Gross pathology:
No substance-related gross organ changes were seen
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD0 is > 3170 mg/kg bw in the rat.
Executive summary:

The substance is practically non-toxic. The dermal LD0 is > 3170 mg/kg bw in the rat.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 170 mg/kg bw

Additional information

Justification for classification or non-classification

The LD50 values in the oral and dermal toxicity studies are > 2000 mg/kg bw. Therefore no classification for acute toxicity is required.