Bottom residues resulting from the synthesis of propylene oxide and styrene from epoxidation of propylene with ethylbenzene hydroperoxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March to May 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD study 402 performed under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bottom product of propylene oxide and styrene production

IUPAC Name:

Bottom product of propylene oxide and styrene production

Details on test material:

- Name of test material (as cited in study report): KORE grade V
- Substance type: UVCB
- Physical state: Brown viscous liquid
- Stability under test conditions: months
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24-hours exposure time

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD 50 of KORE GRADE V - Bottom product of propylene oxide and styrene production, Batch: 21/10/2010, in rats was found to be above 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of KORE GRADE V - Bottom product of propylene oxide and styrene production in rats was determined modified according to the method of the OECD Guideline 402 and the council regulation (EC) 440/2008.

The main study was performed as a limit test with 10 Wistar rats (5 females and 5 males). The rats were exposed to a single dermal dose of 2000 mg/kg bw for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatments were recorded daily. Body weight was recorded once a week. After the 2 weeks observation period, the animals were killed and subjected to a gross necropsy examination.

All animals of both the pilot and the main study survived the treatment. The animals showed lower activity (apathy) propably also caused by the limited mobility resulting from the tape fixation of the patch during the 24 -hour exposition on day 0 only.

The dermal LD50 of KORE GRADE V - Bottom product of propylene oxide and styrene production, Batch: 21/10/2011, in rats was found to be above 2000 mg/kg bw under the experimental conditions described in the report.