tert-pentylbenzene

Endpoint summary

Description of key information

- Acute toxicity by oral route: the oral LD50 value of tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight.

- Acute toxicity by inhalation route: no data available.

- Acute toxicity by dermal route: no data available.

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:

29 December 2009 - 20 January 2010 (in-life phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recent GLP and guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Young adult animals (approx. 9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Method: Oral gavage, using plastic feeding tubes.
- Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available.
- Frequency: Single dosage, on Day 1.

Doses:

2000 mg/kg (2.051 mL/kg) body weight.

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

Tertiary-amylbenzene was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: On Day 1, uncoordinated movements, piloerection and/or salivation was seen among the animals. Rales and tremors were displayed by one animal. Hunched posture was noted in all animals on Days 1 and 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, the oral LD50 value of tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight. Therefore, no classification is required according to EU criteria.

Executive summary:

The acute oral toxicity of tertiary-amylbenzene for rats was determined according to the Acute Toxic Class Method.

The study was carried out based on the guidelines described in:

- OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"

- Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method"

- EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"

- JMAFF guidelines (2000) including the most recent partial revisions.

Tertiary-amylbenzene was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred. On Day 1, uncoordinated movements, piloerection and/or salivation was seen among the animals. Rales and tremors were displayed by one animal. Hunched posture was noted in all animals on Days 1 and 2. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of Tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline and considering the clinical signs noted, the LD50 cut-off value was considered to be 5000 mg/kg body weight. Based on these results, no classification is required according to EU criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Guideline and GLP study.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral route:

One study was available and selected as the key study (OECD No.423, GLP and Reliability.1). Tertiary-amylbenzene was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg . No mortality occurred. On Day 1, uncoordinated movements, piloerection and/or salivation was seen among the animals. Rales and tremors were displayed by one animal. Hunched posture was noted in all animals on Days 1 and 2. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of Tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline and considering the clinical signs noted, the LD50 cut-off value was considered to be 5000 mg/kg body weight.

Inhalation route:

No data is available for this route of administration.

Dermal route:

No data is available for this route of administration.

Justification for classification or non-classification

Harmonized classification:

Not classified.

Self-classification:

As the LD50/rat by oral route is > 2000 mg/kg bw, Tertiary-amylbenzene is not classified according to EU criteria.

By inhalation and dermal routes, no classification is proposed due to lack of data.