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Diss Factsheets

Administrative data

Description of key information

The acute oral toxicity classification of the target substance ADP (CAS 70285-70-0) is currently not harmonised according to the CLP Regulation (EC) 1272/2008. Based on the available acute toxicity data for the source substances ATP, DI-Na (CAS 987-65-5) and AMP (CAS 61-19-8) and according to the read across justification (see attachment "ADP_70285-70-0_Readacross_Justification” in section 13), the target substance ADP (CAS 70285-70-0) has an LD50 > 2000 mg/kg bodyweight and is therefore not classified for acute toxicity by the oral route according to the EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008.


 


ATP, DI-Na (CAS 987-65-5)


No death occurred after the single 2000 mg/kg bw oral dose of ATP, Di-Na. In conclusion, the LD50 of the test item ATP, Di-Na (CAS No 987-65-5) is higher than 2000 mg/kg bodyweight by oral route in the rat. According to the results of this study, the test item is not classified for acute toxicity according to the EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008.


 


AMP (CAS 61-19-8)


No death occurred after the single 2000 mg/kg bw oral dose of AMP. In conclusion, the LD50 of the test item AMP (CAS No 61-19-8) is higher than 2000 mg/kg bodyweight by oral route in the rat. According to the results of this study, the test item is not classified for acute toxicity according to the EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred at 2000 mg/kg bw single oral dose of ATP, Di-Na. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
Clinical signs:
other: No treatment related symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.
Gross pathology:
All animals survived until the scheduled necropsy on Day 15.
Slight hydrometra was observed in animal No.: 6429 of group 1 and severe hydrometra was recorded in female No.: 6432 of the group 1 and in two females (No.: 6439, 6443) of the group 2. Hydrometra is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No death occurred after the single 2000 mg/kg bw oral dose of ATP, Di-Na. The method used, was not intended for the precise calculation of a precise LD50 value.
The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423 as Category 5.
The test item was ranked into classes of the current EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008 as not classified.
Based on the results of the readacross, also the target substance ADP (CAS 70285-70-0) has an LD50 > 2000 mg/kg bodyweight and is therefore not classified for acute toxicity by the oral route according to the EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008.
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attachment "ADP_70285-70-0_Readacross_Justification" in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred at 2000 mg/kg bw single oral dose of AMP. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
Clinical signs:
other: No treatment related symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.
Gross pathology:
All animals survived until the scheduled necropsy on Day 15.
Severe hydrometra was observed in female No.: 5880 of group 1 and in female No.: 5887 of the group 2. Hydrometra is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No death occurred after the single 2000 mg/kg bw oral dose of AMP (CAS No 61-19-8). The method used, was not intended for the precise calculation of a precise LD50 value.
The test item was ranked into classes of the current EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008 as not classified.
Based on the readacross, also the target substance ADP (CAS 70285-70-0) has an LD50 > 2000 mg/kg bodyweight and is therefore not classified for acute toxicity by the oral route according to the EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification