2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, 2-ethylhexyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

28 April 2010 to 12 May 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, undecenyl ester

IUPAC Name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl-, undecenyl ester

Constituent 2

Reference substance name:

Undecenyl methoxycrylene

IUPAC Name:

Undecenyl methoxycrylene

Constituent 3

Reference substance name:

700-824-2

IUPAC Name:

700-824-2

Constituent 4

Reference substance name:

947701-81-7

Cas Number:

947701-81-7

IUPAC Name:

947701-81-7

Constituent 5

Reference substance name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl, 10-undecen-1-yl ester

IUPAC Name:

2-Propenoic acid, 2-cyano-3-(4-methoxyphenyl)-3-phenyl, 10-undecen-1-yl ester

Details on test material:

Sponsor's identification : Undecenyl methoxycrylene
Description : amber coloured viscous liquid
Batch number : ABP5032410
Date received : 12 August 2009
Expiry date: 12 April 2012
Storage conditions : room temperature in the dark

The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.

Test animals

Species:

rat

Strain:

other: Wistar (HsdRccHan:WIST)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK

- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.

- Weight at study initiation: at least 200 g

- Fasting period before study: None

- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes. Housed individually during the 24-hour exposure period and in groups of five, by sex, during the remainder of the study.

- Diet (e.g. ad libitum): Free access to food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK).

- Water (e.g. ad libitum): Free access to mains drinking water.

- Acclimation period: Acclimatisation period of at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C

- Humidity (%): 30 to 70%

- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.

- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

IN-LIFE DATES: 28 April 2010 to 12 May 2010

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test material, as received, was applied to an area of shaved skin representing approximately 10% of the total body surface area.

Surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. Animals were caged individually for the 24-hour exposure perios. Following the exposure period, bandages were carefully removed and surrounding hair wiped with cotton wool moistened with distilled water to remove residual test material.

Duration of exposure:

14 days

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for death and overt toxicity; 0.5, 1, 2 and 4 hours and daily up to fourteen days. Individual animal body weights were obtained on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes

At the end of the study, animals were sacrificed by cervical dislocation. All animals were subject to gross necropsy consisting of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality

Clinical signs:

other: There were no signs of systemic toxicity

Gross pathology:

There were no abnormalities seen at necropsy.

Other findings:

There were no signs of dermal irritation. All individual values corresponding to 0.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.