1,3,5-triisopropylbenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 15 to May 22, 2015

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-triisopropylbenzene

EC Number:

211-941-3

EC Name:

1,3,5-triisopropylbenzene

Cas Number:

717-74-8

Molecular formula:

C15H24

IUPAC Name:

1,3,5-tris(propan-2-yl)benzene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 6F11027000
- Expiration date of the lot/batch: 17.11.2016
- Purity: 96%

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 7-8 wks
- Fasting period before study: 3 hrs
- Housing: In groups of 3 animals in Tecniplast Type 2000P open cages (ca. 10% larger than Eurostandard Type IV cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark, artificial lighting

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 4 mL/ kg bw per gavage
- Justification for choice of vehicle: As the test item's solubility in water is poor, corn oil was used as an organic solvent. Pre­ tests showed that the solubility of the test item in corn oil was sufficient.
- Lot/batch no. (if required): Sigma, Catalogue # 1636
- Purity: 100%

CLASS METHOD
- Rationale for the selection of the starting dose: A starting dose of 2000 mg/kg bw was determined based on information from former studies on the test item (single dose LD50 < 5000 mg/kg bw)

Doses:

Planed: 2000 mg/kg, 300 mg/kg, 50 mg/kg, 5 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For fatalities: twice within 4h after each application, daily for remainder of observation period thereafter. For clinical signs/behavior: daily. For body weight: once before application, then weekly
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: clinical signs (behavior) and body weight

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived during the planned in-life period. No animals died during the study.

Clinical signs:

other: All animals survived during the planned in-life period. Only one animal (E54/0) showed a slight change of behavior shortly after the application (slight lethargy, piloerection at the head, slight abnormal walk).40 minutes later this change was not detecta

Gross pathology:

During necropsy no alterations were found. Only animal ESS/0 of the second run showed a slightly reddened thyroidea.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

according to EC 1278/2008 as amended

Conclusions:

Following the administration of a single dose of 2000 mg/kg body weight of the test item in 6 female rats, no animals died during the study and no animals showed severe suffering or moribundity. A slight reversible change of behavior was detected in one animal as well as minor weight loss in another animal. No distinct changes could be noted during necropsy. The LD50 was therefore expected to overlie 2000 mg/kg bodyweight.

Executive summary:

Following the administration of a single dose of 2000 mg/kg body weight of the test item in 6 female rats, no animals died during the study and no animals showed severe suffering or moribundity. A slight reversible change of behavior was detected in one animal as well as minor weight loss in another animal. No distinct changes could be noted during necropsy. The LD50 was therefore expected to overlie 2000 mg/kg bodyweight.