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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
10 ml/kg
All rats were dosed once only by gavage using a metal cannula attached to a graduated syringe. The dose volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
A group of ten fasted rats (five males and five females) were dosed at the highest dose level used in the range finding study which caused less than 50% mortalities.
Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Mortalities and evidence of overt toxicity were recorded at each observation. Individual bodyweights were recorded on the day of dosing (day 0) and on days 7 and 14.
AlI animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 870 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was recorded
Clinical signs:
other: Hunched posture and piloerection were noted in alI treated animals on the day of dosing and on day one. All animals also showed decreased respiratory rate and orange stained urine at the 4-hour observation. All animals recovered and appeared normal on day
Gross pathology:
No abnormalities were seen at necropsy at the end of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the nominal LC50 was determined to be >5000 mg/kg bw (i.e. >4870 mg a.i./kg bw).
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance to rats according to OECD Guideline 401. Sprague Dawley rats were administered a single dose of the test substance (97.4% purity) in arachis oil via gavage. There were 5 male and 5 female rats per group, exposed to a nominal concentration of 5000 mg/kg bw (equivalent to 4870 mg a.i./kg bw). The animals were then observed during 14 days for mortality and clinical signs. Bodyweights were recorded on the day of dosing and on Days 7 and 14. All animals were subjected to gross necropsy examination for macroscopic abnormalities at test end. No tissues were retained. There was no mortality. Hunched posture and piloerection were noted in alI treated animals on the day of dosing and on Day 1. All rats also showed decreased respiratory rate and orange stained urine at the 4 h observation point. The clinical signs resolved by Day 2. Normal bodyweight gains were recorded throughout the study and no abnormalities were seen at necropsy. Under the study conditions, the nominal LD50 was determined to be >5000 mg/kg bw (i.e. >4870 mg a.i./kg bw) (Archroma, 1986).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Not conducted accoridng to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: RAIf(SPF), F3-hybrid of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
The rat has been selected for this test as being a standard species for the determination of an acute oral LD50.
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 175 to 230 g
Initial Age: 7-8 weeks
Individual Identification: by colour code using picric acid

Husbandry: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with
standardized soft wood bedding (Société Parisienne des sciures, Pantin). The animal room was air conditioned: temperature 22 + 3 °C, relative
humidity 55 + 15 %, 12 hours light/day, approximately 15 air changes/h.

Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5 % carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
One single dose, per os
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Date of acclimatization: August 13, 1986
Date of administration: August 21, 1986
Date of completion: September 4, 1986
Volume (ml/kg body weight) applied: 20

Pretreatment: Prior to dosing, the animals were fasted overnight.
Administration: oral, by gastric intubation (gavage)
Observation period: 14 days

Observations and records
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily
Body weight: on days 1, 7, and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 125 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was observed
Clinical signs:
other: Slight dispnea, exophthalmos, ruffled fur and hunched position, recovered in 12 days
Gross pathology:
No deviations from normal morphology were found
Interpretation of results:
GHS criteria not met
Conclusions:
The substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance to rats according to OECD Guideline 401. RAIf(SPF) F3-hybrid of RII 1/Tif x RII 2/Tif rats (5 males and 5 females per group) were exposed to the test substance (62.5% purity) diluted in distilled water containing 0.5 % carboxymethylcellulose and 0.1% polysorbate 80 via gavage at 5000 mg/kg bw (equivalent to 3125 mg a.i./kg bw). Animals were fasted overnight before dosing. Mortality and clinical signs were recorded twice daily or daily for 14 days. Bodyweights were measured on Days 1, 7 and 14 and the animals were submitted to a gross necropsy at the end of the observation period. There was no mortality. Clinical signs included slight dyspnea, exophthalmos, ruffled fur and hunched position, with full recovery within 12 days. No effects on bodyweight or deviations from normal morphology were found. Under the study conditions, the nominal LD50 was determined to be >5000 mg/kg bw (i.e. >3125 mg a.i./kg bw) (Huntsman, 1986).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35%
Doses:
10000 mg/kg
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: at least twice daily
- Necropsy of survivors performed: yes
Statistics:
NA
Preliminary study:
NA
Key result
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks:
purity 40%
Mortality:
no effects
Clinical signs:
other: slight dyspnea, some animals apathia, prone position, diarrhea, bad general condition, black discolouration of faeces
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute oral LD50 of the test substance in rats was determined to be 10000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to an internal procedure. A single dose of 10000 mg/kg was administered to the test rats through oral gavage. Under the study conditions, the acute oral LD50 of the test substance in rats was determined to be 10000 mg/kg bw (Munk, 1977).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 870 mg/kg bw
Quality of whole database:
Good quality database

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Principles of method if other than guideline:
The test was conducted according to an internal procedure.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks:
saturated with test item
Details on inhalation exposure:
Inhalation by means of inhalation of test substance saturated atmosphere for 8 h. To achieve saturation, air was fed through an approx. 5 cm deep layer of the test substance.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
saturation concentration
No. of animals per sex per dose:
12 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: daily observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy
Statistics:
NA
Preliminary study:
NA
Key result
Sex:
not specified
Dose descriptor:
LC0
Based on:
test mat.
Remarks:
40% purity
Exp. duration:
8 h
Remarks on result:
other: no effect at saturation concentration
Mortality:
no deaths
Clinical signs:
other: no effects
Body weight:
no data
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, no mortality was observed in the treated rats.
Executive summary:

A study was conducted to determine the acute inhalation toxicity of the test substance according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereby observed for 14 d. Under the study conditions, no mortality was observed in the treated rats (Munk, 1977).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY
Sex:
male
Details on test animals or test system and environmental conditions:
Weight range: 244 to 264 g
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface
- Type of wrap if used: aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm (40-50°C) dilute soap solution, rinsing in clean warm water
- Time after start of exposure: 24 h

Duration of exposure:
24 hours
Doses:
5 mL/kg bw
No. of animals per sex per dose:
10 male rats
Control animals:
yes
Remarks:
treated with water
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: clinical signs daily; body weight weekly
- Necropsy of survivors performed: yes
Statistics:
NA
Preliminary study:
NA
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Mortality:
no deaths
Clinical signs:
other: slight lethargy and piloerection
Gross pathology:
congestion of the lungs ond pale or uneven col.ouration of the liver and kidneys. Five rats had haemorrhage of.the subcutaneous blood vessels of the treated areas.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, acute dermal LD50 of the test substance in rats was determined to be greater than 5 mL/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance according to a method equivalent to OECD Guideline 402. No mortality was observed in the treated rats. According to the study conditions, the acute dermal LD50 of the test substance was determined to be greater than 5 mL/kg bw (Davies, 1974).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Oral

A study was conducted to determine the acute oral toxicity of the test substance to rats according to OECD Guideline 401. Sprague Dawley rats were administered a single dose of the test substance (97.4% purity) in arachis oil via gavage. There were 5 male and 5 female rats per group, exposed to a nominal concentration of 5000 mg/kg bw (equivalent to 4870 mg a.i./kg bw). The animals were then observed during 14 d for mortality and clinical signs. Bodyweights were recorded on the day of dosing and on Days 7 and 14. All animals were subjected to gross necropsy examination for macroscopic abnormalities at test end. No tissues were retained. There was no mortality. Hunched posture and piloerection were noted in alI treated animals on the day of dosing and on Day 1. All rats also showed decreased respiratory rate and orange stained urine at the 4 h observation point. The clinical signs resolved by Day 2. Normal bodyweight gains were recorded throughout the study and no abnormalities were seen at necropsy. Under the study conditions, the nominal LD50 was determined to be >5000 mg/kg bw (i.e. >4870 mg a.i./kg bw) (Archroma, 1986).

A study was conducted to determine the acute oral toxicity of the test substance to rats according to OECD Guideline 401. RAIf(SPF) F3-hybrid of RII 1/Tif x RII 2/Tif rats (5 males and 5 females per group) were exposed to the test substance (62.5% purity) diluted in distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 via gavage at 5000 mg/kg bw (equivalent to 3125 mg a.i./kg bw). Animals were fasted overnight before dosing. Mortality and clinical signs were recorded twice daily or daily for 14 d. Bodyweights were measured on Days 1, 7 and 14 and the animals were submitted to a gross necropsy at the end of the observation period. There was no mortality. Clinical signs included slight dyspnea, exophthalmos, ruffled fur and hunched position, with full recovery within 12 d. No effects on bodyweight or deviations from normal morphology were found. Under the study conditions, the nominal LD50 was determined to be >5000 mg/kg bw (i.e. >3125 mg a.i./kg bw) (Huntsman, 1986).

A study was conducted to determine the acute oral toxicity of the test substance according to an internal procedure. A single dose of 10000 mg/kg was administered to the test rats through oral gavage. Under the study conditions, the acute oral LD50 of the test substance in rats was determined to be 10000 mg/kg bw (Munk, 1977).

Inhalation

A study was conducted to determine the acute inhalation toxicity of the test substance according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereby observed for 14 d. Under the study conditions, no mortality was observed in the treated rats (Munk, 1977).

Dermal

A study was conducted to determine the acute dermal toxicity of the test substance according to a method equivalent to OECD Guideline 402. No mortality was observed in the treated rats. According to the study conditions, the acute dermal LD50 of the test substance was determined to be greater than 5 mL/kg bw (Davies, 1974).

Justification for classification or non-classification

Based on the results of acute toxicity studies in the rat, the test substance does not require classification according to CLP (EC 1272/2008) criteria.