Registration Dossier

Administrative data

Description of key information

Read- across: key, TP 1740, rat, OECD 429 (Class method), GLP, LD50 > 2000 mg/kg bw (Caruso 2018)

Read-across: supporting, FF6, rat OECD 401 (standard acute method), GLP, LD50 > 2000 mg/kg bw (Müller 1998)

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
Reason / purpose:
read-across source
Reason / purpose:
assessment report
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in the 6 animals following dosing at 2000 mg/kg.
Clinical signs:
No signs of toxicity were observed in the 6 animals following dosing at 2000 mg/kg.
Body weight:
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
Gross pathology:
No abnormalities were seen at necropsy examination performed on all animals dosed at 2000mg/kg (Groups 2 and 4) at the end of the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000 mg/kg body weight.
Executive summary:

The acute toxicity of TP1740 was investigated following OECD 429 (Class method) and GLP. A single oral administration to the Sprague Dawley rat was followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no clinical signs were noted. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were seen at necropsy examination performed at the end of the observation period on animals of both groups. These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000 mg/kg body weight. The source substance has the identical organic molecular moieties as the target substance TP 1646. Therefore, the acute toxicity of the target substance is expected to be similar to the source substance.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reason / purpose:
read-across source
Reason / purpose:
assessment report
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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:
Signs of toxicity related to dose levels: On the day of administration of the test article a slight apathy was observed in all animals and a slight squatting position was shortly observed in one male and in two female animals. None of the animals showed further alterations of their general state of well-being and behaviour.
Body weight:
The body weight gain was not affected.
Gross pathology:
No macroscopic pathological findings in the animals.

Other findings:
none
Interpretation of results:
GHS criteria not met
Conclusions:
The test item is neither a toxic nor a harmful substance according to this acute oral toxicity study.
Executive summary:

Acute oral toxicity of the test item was tested in male and female Charles River Wistar rats following OECD Guideline 401 and GLP. The test article was administered at a single dose of 2000 mg/kg body weight by gavage. Animals were examined for mortality, clinical signs, body weight gain and pathological alterations of organs at the end of a 14-day observation period. None of the animals died during the course of investigation. On the day of administration of the test article a slight apathy was observed in all animalsand a slight squatting position was shortly observed in one male and in two female animals. No pathological findings were observed at necropsy. The body weight gain was not affected.

The LD50 is > 2000 mg/kg body weight .

The source substance contains the major organic moieties (hydroxysulfi(o)natoacetates) that are identical to the target substance. Therefore, this study shows that no acute oral toxicity can be attributed to the hydroxysulfi(o)natoacetate moieties of the target substance TP 1646.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Since two GLP and OECD guideline compliant are available with adequate source substance, the quality of the database is high.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Due to the highly similar composition and the high reliability of the study, the acute oral toxicity study of TP 1740 is the key study for this endpoint.

The acute toxicity of TP1740 was investigated following OECD 429 (Class method) and GLP. A single oral administration to the Sprague Dawley rat was followed by a 14-day observation period. A first group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no clinical signs were noted. Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were seen at necropsy examination performed at the end of the observation period on animals of both groups. These results indicate that the test item did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000 mg/kg body weight. The source substance has the identical organic molecular moieties as the target substance TP 1646. Therefore, the acute toxicity of the target substance is expected to be similar to the source substance.

This result is supported by a study result of the other source substance FF6.

The acute oral toxicity of FF6 was tested in male and female Charles River Wistar rats following OECD Guideline 401 and GLP. The test article was administered at a single dose of 2000 mg/kg body weight by gavage. Animals were examined for mortality, clinical signs, body weight gain and pathological alterations of organs at the end of a 14-day observation period. None of the animals died during the course of investigation. On the day of administration of the test article a slight apathy was observed in all animals and a slight squatting position was shortly observed in one male and in two female animals. No pathological findings were observed at necropsy. The body weight gain was not affected. The LD50 is > 2000 mg/kg body weight . The source substance contains the major organic moieties (hydroxysulfi(o)natoacetates) that are identical to the target substance. Therefore, this study shows that no acute oral toxicity can be attributed to the hydroxysulfi(o)natoacetate moieties of the target substance TP 1646.

Justification for classification or non-classification

Based on the results for the source substances the target substance is not classified according to Regulation (EC) No 1272/2008.