Registration Dossier

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 guidelineopen allclose all
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

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

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:
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.

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.