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Description of key information

Two acute toxicity tests were conducted, an oral and a dermal study. For both exposure routes, the acute oral median lethal dose (LD50) of the test material in rats was estimated to be greater than 2000 mg/kg bodyweight.

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:
05.11.2014 to 01.07.2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Rat (Rattus norvegicus) / CD / Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
Species / Strain / Stock: Rat (Rattus norvegicus) / CD / Crl: CD(SD)
Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Selection of species: International recommendations; EC, OECD and OCSPP (OPPTS) guidelines
Sex: Female
Number of animals: 6 female animals
Group: 1 dose level group of 6 female animals - Limit test -
Body weight (at start of 1st administration): 170 - 200 g
Age (at start of administration) Approx: 8 weeks
Identification of animals: By coloured marks and cage label
Duration of experiment: At least 5 adaptation days 1 test day 2 recovery weeks
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Administration volume: 1.96 mL/kg b.w.
Doses:
Dose level: 2000 mg/kg b.w. (limit test)
No. of animals per sex per dose:
6 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
none
Clinical signs:
none
Body weight:
All animals gained the expected body weight at the end of the study period.
Gross pathology:
none
Interpretation of results:
GHS criteria not met
Conclusions:
In this experiment Di-(iso)-pentyl-terephthalate (DPT) was examined for acute toxicity after a single oral administration to rats (limit test).
Under the present test conditions, a single oral administration of 2000 mg Di-(iso)-pentyl-terephthalate (DPT)/kg b.w. did not reveal any clinical signs of toxicity.
All animals gained the expected body weight at the end of the study period.
No pathological changes were observed at necropsy.
The LD50 value was ranked exceeding 2000 mg/kg b.w..
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

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:
2015-03-10 to 2015-06-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CD/Crl:CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories (Sulzfeld, Germany)
- Age at study initiation: Males approx. 8 weeks, Females approx. 10 weeks
- Weight at study initiation: Males: 211-250 g, Females: 206-224 g
- Housing: granulated textured wood, MAKROLON cages during observation period
- Diet (e.g. ad libitum): discontinued approx. 16 h before administration
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 h each

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back between the fore and hind extremities (5 cm x 6 cm)
- % coverage: 10 % of body surface
- Type of wrap if used: in contact with the skin with 8 layers of gauze

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.96 mL/kg b.w.

Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations: before and immediately, 5, 15, 30 and 60 min, 3, 6 and 24 h after administration. All animals were observed for a period of 14 days.
Body weights: before administration and after in weekly intervals up to the end
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin reactions, mortality, necropsy findings
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Effect level above the highest dose
Mortality:
No death was recorded.
Clinical signs:
Not observed
Body weight:
All animals gained the expected weight throughout the whole study period.
Gross pathology:
No signs of abnormalities were noted at necropsy.
Other findings:
No skin reactions were observed at the application site.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute median lethal dermal dose (LD50) to rats of Di-(iso)-pentyl terephthalate (DPT) was demonstrated to be greater than 2000 mg/kg bodyweight (limit test). No deaths, clinical signs and macroscopic necropsy findings were observed. No classification is needed.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity study:

In this experiment Di-(iso)-pentyl-terephthalate (DPT) was examined for acute toxicity after a single oral administration to rats (limit test). The method was designed to meet the requirements of the OECD guideline 423, EC method B.1 tris - ATC method - and OCSPP (OPPTS) guideline 870.1100.

Under the present test conditions, a single oral administration of 2000 mg Di-(iso)-pentyl-terephthalate (DPT)/kg b.w. did not reveal any clinical signs of toxicity.

All animals gained the expected body weight at the end of the study period.

No pathological changes were observed at necropsy.

The LD50value was ranked exceeding 2000 mg/kg b.w. by oral administration.

Acute dermal toxicity study:

In this experiment Di-(iso)-pentyl terephthalate (DPT) was examined for acute toxicity after a single dermal application to rats. One dose level of 2000 mg/kg b.w. was employed (limit test). The method was designed to meet the requirements of the OECD guideline 402, EC method B.3 and OCSPP (OPPTS) 870.1200.

Under the present test conditions, a single dermal administration of 2000 mg

Di-(iso)-pentyl terephthalate (DPT)/kg b.w. did not reveal any signs of toxicity. No death was recorded within the test period (one dosing day and 14 recovery days).

All animals gained the expected weight throughout the whole study period.

No skin reactions were observed at the application site.

No signs of abnormalities were noted at necropsy.

The LD50value was ranked exceeding 2000 mg/kg b.w. by dermal administration.

 

Justification for classification or non-classification

Based on the available studies, the test substance is not classified for acute toxicity according to EC Regulation No. 1272/2008.