Allyl phenoxyacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Non-GLP study performed acccording to guidelines of the USA Interagency Regulatory Liaison Group (IRLG) Testing Standards and Guidelines Work Group (January 1981). No information on purity was given; occlusive application

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

The skin was abraded prior to treatment; occlusive application; No information on purity was given.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Allyl phenoxyacetate

EC Number:

231-335-2

EC Name:

Allyl phenoxyacetate

Cas Number:

7493-74-5

Molecular formula:

C11H12O3

IUPAC Name:

allyl phenoxyacetate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7-11 weeks
- Weight at study initiation: 225-240 g (males), 205-220 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: individually in solid-bottom polypropylene boxes, softwood sawdust was used as bedding material
- Diet: R 4 Alleindiät für Ratten (Ssniff Versuchstier-GmbH, Soest, Germany), ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a porous gauze dressing and occluded with a strip of impermeable adhesive plaster wound around the trunk.
The application site was abraded using a sterile clipper head immediately prior to treatment.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin and surrounding areas were wiped with a moist disposable towel to remove any residual test substance.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: 1.7 mL/kg bw
- Constant concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 15 and 30 min and 1, 2 and 4 h after administration and subsequently once daily for 14 days. Individual body weights were determined on day before treatment (Day -1), on the day of treatment (Day 0) and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: histopathological examination of the kidney, liver and (treated) skin tissue of 3 males and 3 females

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period of the main study.

Clinical signs:

other: Clinical changes like lacrimation, half-closed eyes, soft faeces and exophthalmia were observed on the application day. All animals appeared normal on Day 2 after treatment.

Gross pathology:

No significant pathological changes were found.

Other findings:

- Histopathology: liver: small intralobular/periportal infiltrates of round cells and congestion; kidneys: focal, subacute, interstitial nephritis in the cortex, focal proliferation of epithelial cells in the renal tubules and small interstitial infiltrates of round cells in the cortex; skin: slight hyperkeratosis

Any other information on results incl. tables

Details on test animals:

- Source: Charles River Wiga GmbH, Sulzfeld, Germany

The abraded skin of all animals appeared normal throughout the study period.

Histopathological examination revealed small intralobular/periportal infiltrates of round cells and congestion in the liver. In the kidneys, focal subacute, interstitial nephritis in the cortex, focal proliferation of epithelial cells in the renal tubules and small interstitial infiltrates of round cells in the cortex were observed. Furthermore, slight hyperkeratosis was found in skin tissues.

Evaluation of the histopathological findings:

A slight hyperkeratosis of the skin is an indication for minimal irritation on the application site. Small infiltrates of round cells in liver and kidneys as well as a slight focal interstitial nephritis are indications for small local infections as they can frequently be found in rats under conventional husbandry. In that connection, small focal proliferates of epithelial cells in the renal tubules were also found. The congestion is conditioned by the fact that the animals were not exsanguinated.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute dermal toxicity study a LD50 value > 2000 mg/kg bw in male and female rats was found.