Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted Feb 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate

EC Number:

940-272-6

Cas Number:

2097734-13-7

Molecular formula:

C18H26O4

IUPAC Name:

Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: CD/Crl:CD(SD)

Sex:

male/female

Details on test animals or test system 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

Administration / exposure

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

Results and discussion

Effect levels

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:

other: Not observed

Gross pathology:

No signs of abnormalities were noted at necropsy.

Other findings:

No skin reactions were observed at the application site.

Applicant's summary and conclusion

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.