3-(p-methoxyphenyl)-2-methylpropionaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 Aug 1980 to 30 Sep 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

EC Number:

226-749-5

EC Name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

Cas Number:

5462-06-6

Molecular formula:

C11H14O2

IUPAC Name:

3-(4-methoxyphenyl)-2-methylpropanal

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nicolas Helf, Ace Animals
- Age at study initiation: 8 weeks
- Weight at study initiation: 2.1 - 3.0 kg
- Housing: 2/ cage in suspended wire mesh cages
- Diet: Fresh Purina rabbit chow was freely available
- Water: Water was freely available
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
The room, reserved exclusively for rabbits on acute tests, was temperature controlled and was kept clean in accordance with the standards of AAALAC.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Immediately prior to dosing, the fur was clipped from the abdomen at an area of 200 cm²
- Coverage: 10%
- Type of wrap if used: Gauze patches secured with adhesive tape. The trunks were wrapped with impervious material.
- Other: Abrasions were made in 1/2 of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding.

DOSE VOLUME:
- 10.3 to 14.7 cc

REMOVAL OF TEST SUBSTANCE
- Washing: The exposure site was wiped, but not washed
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

5.0 g/ kg

No. of animals per sex per dose:

10 animals (6 males, 4 females): First 2 animals were dosed at 5.0 g/ kg. If no deaths occurred, additional animals were dosed at 5.0 g/kg. If more than one half of the animals died at the 5.0 g/ kg level, the LD50 was determined.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Dermal reactions were scored at 1, 7 and 14 days by the Draize scoring system.
- The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality.
- Body weights were recorded pretest and in the survivors at 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0/10 animals died on the first day in the 14 day observation period after exposure to 5.0 g/kg test substance.

Clinical signs:

other: - Temporary diarrhea or decreased feces observed in six animals. - In one animal alopecia and ptosis was observed.

Gross pathology:

At necropsy 6/10 rabbits had scaly treated skin. The internal organs on superficial examination appeared normal.

Other findings:

Erythema and edema, generally slight on days 1 and 7, cleared by day 14.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (1272/2008 and its updates)

Conclusions:

The acute dermal toxicity test showed an LD50 > 5000 mg/kg bw.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 10 rabbits (6 male, 4 female) were administered with 5000 mg/kg test substance on the intact or scratched skin. The animals were exposed for 24 hours under occlusive conditions. None of the animals died in the 14 day observation period after exposure to the test substance. Slight to moderate erythema and edema, were observed on days 1 and 7 in 6 animals, but was cleared by day 14. Systemic effects included diarrhea or decreased feces in six animals and in one animal alopecia and ptosis were observed. 4/10 animals exhibited a slight weight loss during the 14 day observation period. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was > 5000 mg/ kg bw.