Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral in rats: LD50 = 890 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel. 2)

Acute toxicity, dermal in rabbits: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 402, non-GLP, K, Rel.2)

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 401 with deviations: purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not weighed after dosing; gross pathology not reported
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not; gross pathology not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
340, 670, 1310, 2560 and 5000 mg/kg bw
No. of animals per sex per dose:
10 /dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination.
Statistics:
None
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
890 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Deaths occurred at day 13 (1 animal) and 14 (2 animals) following administration of test item at the dose of 670 mg/kg bw, and overnight (4 animals), Day 1 (2 animals) and Day 2 (1 animal) following administration of test item at 1310 mg/kg bw
Mortality:
- Deaths occurred overnight to 14 days following administration of test item.
- 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.
Clinical signs:
diarrhea at 670 mg/kg, lethargy and flaccid rats at 1310 mg/kg, and lethargy, diarrhea and flaccid rats at 5000 mg/kg were observed
Body weight:
- No data
Gross pathology:
- No data
Other findings:
None

None

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw by oral route in the rat.
According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.
Executive summary:

In an acute oral toxicity study performed similarly to Guideline OECD 401, groups (10 /dose) of rats were given a single oral dose of Nopol at 340, 670, 1310, 2560 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.

Diarrhea, lethargy and flaccid rats were observed. Deaths occurred overnight to 14 days following administration of the test item. 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.

In this study, the oral LD50 of the test item was 890 mg/kg bw.

The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw.

According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
890 mg/kg bw
Quality of whole database:
acute oral toxicity study performed similarly to OECD Guideline 401

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 402 with deviations: purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
purity of test item not reported; duration of exposure, source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
2500 and 5000 mg/kg bw
No. of animals per sex per dose:
2 animals at 2500 mg/kg and 8 at 5000 mg/kg
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 3 days
- Necropsy of survivors performed: Yes; gross necropsy was performed on all animals at the termination of the study.
Statistics:
None
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: One rabbit died on Day 2 and one on day 3, out of 8 animals
Mortality:
One rabbit died on Day 2 and one on Day 3
Clinical signs:
Slight redness at 5000 mg/kg in one rat and moderate redness and edema in others, ataxia, ptosis and piloerection were observed.
Body weight:
No data
Gross pathology:
Liver mottled, lungs dark and area of exposure very red and edematous in one animal.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.
Executive summary:

In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.

Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw. The dermal LD50 of the test item was considered to be higher than 5000 mg/kg bw in rabbits.

The acute dermal LD50 of Nopol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
acute dermal toxicity study performed similarly to OECD Guideline 402

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similarly to Guideline OECD 401, groups (10 /dose) of rats were given a single oral dose of Nopol at 340, 670, 1310, 2560 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.

 Diarrhea, lethargy and flaccid rats were observed. Deaths occurred overnight to 14 days following administration of the test item. 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.

The oral LD50 for Nopol was evaluated to 890 mg/kg mg/kg bw in rats wich is higher than 300 mg/kg body weight and lower than 2000 mg/kg by oral route in the rat.

Acute dermal toxicity:

In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.

Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw.

The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits.

Justification for classification or non-classification

Acute oral toxicity:

The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw by oral route in the rat.

According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.

Acute dermal toxicity:

The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP regulation EC No. 1272/2008 and GHS.