Undecan-4-olide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 July - 05 August 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted according to OECD Guideline 402 with minor deviations: no certificate of analysis of the test substance

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

no certificate of analysis of the test substance

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undecan-4-olide

EC Number:

203-225-4

EC Name:

Undecan-4-olide

Cas Number:

104-67-6

Molecular formula:

C11H20O2

IUPAC Name:

5-heptyloxolan-2-one

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): 2(3H)-Furanone, 5-heptyldihydro; ALDEHYD C14 SOG; HR 99/606009 (Test no. 1999224)
- Physical state: Colourless slightly viscous liquid
- Analytical purity: 98.3 %
- Specific gravity: 0.935
- Date received: 21 June 1999
- Batch No.: 9020026
- Storage condition of test material: Approximately 4 °C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Males: 222-233 g; females: 211-226 g
- Housing: Animals were housed in suspended polypropylene cages furnished with woodflakes. Animals were housed individually during the 24 h exposure period and in groups of 5/sex for the remainder of the study.
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diets Services Limited, Essex, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 15/h
- Photoperiod: 12 h darkness / 12 h continuous light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Test material was applied on the shorn skin of back and flank region.
- % coverage: Approximately 10 % of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: After 24 h contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 mL/kg bw
- Constant volume or concentration used: Yes

Duration of exposure:

24 h

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: Animals were observed for deaths or overt signs of toxicity at 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Individual body weights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes, all the animals were killed by cervical dislocation at the termination of study and subjected to gross pathological examination.
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to the method of Draize (1977).

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No signs of systemic toxicity or skin irritation were noted.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of γ-Undecalactone, is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a groups of 10 rats (5/sex) of Sprague-Dawley CD (Crl:CD (SD) IGS BR) strain was administered a single dermal dose of γ-Undecalactone, at 2000 mg/kg bw on clipped skin using a semi-occlusive patch for 24 h. Animals were then observed for mortality, clinical signs, bodyweights and dermal reactions for 14 days and were all macroscopically necropsied after sacrifice.

No deaths occurred throughout the study. No signs of systemic toxicity or skin irritation were noted. Animals showed an expected gain in body weight during the study. No abnormalities were noted at necropsy. In this study, the acute dermal LD50 of γ-Undecalactone, was considered to be higher than 2000 mg/kg bw in rats.

Under the test conditions, the combined acute dermal LD50 of γ-Undecalactone, is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.