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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

 


The test substance has been tested in one repeated dose toxicity study (28 days) according to OECD guideline 422 and revealed no test-item related signs of toxicity. The NOAEL for systematic toxicity is above the highest administered dose 1000 mg test item/kg b.w./day, p.o.. In addition, a repeated dose toxicity study (90 days) according to OECD TG 408 was conducted with DPT and revealed no test-item related effects. Based on these results, the NOAEL was established as being at least 1000 mg/kg/day for males and females. No substance related local or systemic adverse effects could be observed up to the tested limit dose.


 


Moreover, administration of Di‑(iso)‑pentyl terephthalate (DPT), by once daily oral gavage in an OECD TG 443 was well tolerated in male and female rats at dose levels of up to the limit dose of 1000 mg/kg/day, with no effects on development and reproductive function and no adverse test item related systemic toxicity effects. Based on the results of this extended one generation reproductive toxicity study (Cohort 1A, Cohort 1B), the following no-observed-adverse-effect level (NOAEL) of DPT were established: Parental toxicity (F0 and F1): 1000 mg/kg/day;  Reproductive NOAEL (F0 and F1): 1000 mg/kg/day; Post-Natal Developmental NOAEL (F1 and F2): 1000 mg/kg/day


 


In the prenatal developmental toxicity study in rats according to OECD TG 414 no maternal toxicity was observed up to the highest dose level tested (1000 mg/kg/day). Moreover, no developmental toxicity was observed up to the highest dose level tested (1000 mg/kg/day). In conclusion, based on the results of this prenatal developmental toxicity study in rats the maternal and developmental No Observed Adverse Effect Levels for DINCD were reported to be at least 1000 mg/kg bw/d. In prenatal developmental toxicity study in rabbits. The administration of DPT by once daily oral gavage in pregnant rabbits at the highest dose level of 300 mg/kg bw/day caused body weight loss and lower mean food consumption. In addition, at 300 mg/kg bw/day one animal was found dead following low food consumption which was considered to be test-item related. All the observed effects (except mortaliyt) were observed in all treatment groups (including control, but to a lesser degree) and were attributed to general palatability effects due to oily vehicle for gavage administration. No effects were seen for any other toxicological endpoint and histopathology, respectively.


Therefore, the NOAEL for maternal toxicity in prenatal developmental toxicity testing in rabbits is considered not relevant for DNEL derivation. In addition, no toxicologically relevent effects were reported in toxicity studies with rats in males and females at the limit dose of 1000 mg/kg bw/day.


 


For dermal route of exposure, no adverse effects were reported in the in vitro skin irritation/corrosion study and in the in vivo skin sensitization study.


 


Conclusion:


 


No relevant effects (local or systemic)  have been observed at limit dose in available guideline toxicological studies. Thus, no hazard could be identified and no DNEL/DMEL is derived. This applies for oral, dermal and inhalation exposure since a comparable toxicity profile is to be expected for all three routes of exposure.    

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

 


The test substance has been tested in one repeated dose toxicity study (28 days) according to OECD guideline 422 and revealed no test-item related signs of toxicity. The NOAEL for systematic toxicity is above the highest administered dose 1000 mg test item/kg b.w./day, p.o.. In addition, a repeated dose toxicity study (90 days) according to OECD TG 408 was conducted with DPT and revealed no test-item related effects. Based on these results, the NOAEL was established as being at least 1000 mg/kg/day for males and females. No substance related local or systemic adverse effects could be observed up to the tested limit dose.


 


Moreover, administration of Di‑(iso)‑pentyl terephthalate (DPT), by once daily oral gavage in an OECD TG 443 was well tolerated in male and female rats at dose levels of up to the limit dose of 1000 mg/kg/day, with no effects on development and reproductive function and no adverse test item related systemic toxicity effects. Based on the results of this extended one generation reproductive toxicity study (Cohort 1A, Cohort 1B), the following no-observed-adverse-effect level (NOAEL) of DPT were established: Parental toxicity (F0 and F1): 1000 mg/kg/day;  Reproductive NOAEL (F0 and F1): 1000 mg/kg/day; Post-Natal Developmental NOAEL (F1 and F2): 1000 mg/kg/day


 


In the prenatal developmental toxicity study in rats according to OECD TG 414 no maternal toxicity was observed up to the highest dose level tested (1000 mg/kg/day). Moreover, no developmental toxicity was observed up to the highest dose level tested (1000 mg/kg/day). In conclusion, based on the results of this prenatal developmental toxicity study in rats the maternal and developmental No Observed Adverse Effect Levels for DINCD were reported to be at least 1000 mg/kg bw/d. In prenatal developmental toxicity study in rabbits. The administration of DPT by once daily oral gavage in pregnant rabbits at the highest dose level of 300 mg/kg bw/day caused body weight loss and lower mean food consumption. In addition, at 300 mg/kg bw/day one animal was found dead following low food consumption which was considered to be test-item related. All the observed effects (except mortaliyt) were observed in all treatment groups (including control, but to a lesser degree) and were attributed to general palatability effects due to oily vehicle for gavage administration. No effects were seen for any other toxicological endpoint and histopathology, respectively.


Therefore, the NOAEL for maternal toxicity in prenatal developmental toxicity testing in rabbits is considered not relevant for DNEL derivation. In addition, no toxicologically relevent effects were reported in toxicity studies with rats in males and females at the limit dose of 1000 mg/kg bw/day.


 


For dermal route of exposure, no adverse effects were reported in the in vitro skin irritation/corrosion study and in the in vivo skin sensitization study.


 


Conclusion:


 


No relevant effects (local or systemic)  have been observed at limit dose in available guideline toxicological studies. Thus, no hazard could be identified and no DNEL/DMEL is derived. This applies for oral, dermal and inhalation exposure since a comparable toxicity profile is to be expected for all three routes of exposure.