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Description of key information

The acute oral toxicity was tested in rats at dose levels of 5000 mg/kg bw. No deaths or signs of toxicity was observed in these studies.

The structural analogue was tested in a dermal acute toxicity study at a limit dose of 2000 mg/kg bw in male and female rats. No deaths or signs of toxicity was observed in this study.

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:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Without GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 9 week, females: 14 weeks
- Weight at study initiation: males: 151 to 167 g; females: 156 to 177 g
- Fasting period before study: yes - 16 hours before to 4 hours after dosing
- Housing: groups of 5 rats/sex
- Diet (e.g. ad libitum): Altromin R 1324 ad lib
- Water (e.g. ad libitum): tap water ad lib
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: July/August 1982
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: water soluble substance
- Lot/batch no. (if required): -
- Purity: -

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: observations on treatment day: multiple times, thereafter twice daily on week days, once daily on week-ends
weighing: Day 1, 7, 14
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no effect
Gross pathology:
no abnormalities
Interpretation of results:
GHS criteria not met
Conclusions:
No deaths or adverse effects were observed in male and female rats at a dose level of 5000 mg/kg bw. Hence the LD0 and Ld50 is above 5000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Without GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 9 week, females: 14 weeks
- Weight at study initiation: males: 167 to 173 g; females: 160 to 171 g
- Fasting period before study: yes - 16 hours before to 4 hours after dosing
- Housing: groups of 5 rats/sex
- Diet (e.g. ad libitum): Altromin R 1324 ad lib
- Water (e.g. ad libitum): tap water ad lib
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: February 1983
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: water soluble substance
- Lot/batch no. (if required): -
- Purity: -

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: observations on treatment day: multiple times, thereafter twice daily on week days, once daily on week-ends
weighing: Day 1, 7, 14
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no effect
Gross pathology:
no abnormalities
Interpretation of results:
GHS criteria not met
Conclusions:
No deaths or adverse effects were observed in male and female rats at a dose level of 5000 mg/kg bw. Hence the LD0 and LD50 is above 5000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Without GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 9 week, females: 14 weeks
- Weight at study initiation: males: 165 to 180 g; females: 164 to 174 g
- Fasting period before study: yes - 16 hours before to 4 hours after dosing
- Housing: groups of 5 rats/sex
- Diet (e.g. ad libitum): Altromin R 1324 ad lib
- Water (e.g. ad libitum): tap water ad lib
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: May 1983
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: water soluble substance
- Lot/batch no. (if required): -
- Purity: -

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: observations on treatment day: multiple times, thereafter twice daily on week days, once daily on week-ends
weighing: Day 1, 7, 14
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no effect
Gross pathology:
no abnormalities
Interpretation of results:
GHS criteria not met
Conclusions:
No deaths or adverse effects were observed in male and female rats at a dose level of 5000 mg/kg bw. Hence the LD0 and LD50 is above 5000 mg/kg bw.
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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: males: ca 7 weeks; females: ca 8 weeks
- Weight at study initiation: mean: males: 178 g; females: 184 g
- Fasting period before study: NA
- Housing: single
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25.11.1987 To: 9.12.1987
Type of coverage:
occlusive
Vehicle:
physiological saline
Remarks:
0.9% NaCl solution in the proportion of 1 g + 1 ml to form a paste
Details on dermal exposure:
Area: 30 cm²

Duration of exposure:
24 h
Doses:
2000 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: body weight: weekly; clinical signsand mortality: frequently first day; twice daily thereafter
- Necropsy of survivors performed: yes
Statistics:
NA
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
no sytemic clinical signs were observed
Body weight:
body weight development of the animals was normal.
Gross pathology:
No effects observed
Other findings:
Blue or red to purple discolored skin up to 6 days after test substance application
Interpretation of results:
GHS criteria not met
Conclusions:
No mortality occured among male and female rats in an OECD 402 limit test. The LD50 (rat) is > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

No deaths or systemic adverse effects were observed in the acute toxicity studies with either route of administration. hence, no classification is necessary