(E)-3-methyl-5-cyclopentadecen-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1991-07-18 to 1991-08-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 402 and in compliance with GLP with acceptable restrictions: the % area exposed is not mentioned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

% area exposed not mentioned

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 19 June 1990. Signed on 5 October 1990.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(5E)-3-Methyl-5-cyclopentadecen-1-one

Cas Number:

101151-17-1

Molecular formula:

C16 H28 O

IUPAC Name:

(5E)-3-Methyl-5-cyclopentadecen-1-one

Constituent 2

Reference substance name:

(5Z)-3-Methyl-5-cyclopentadecen-1-one

Cas Number:

21944-94-5

Molecular formula:

C16 H28 O

IUPAC Name:

(5Z)-3-Methyl-5-cyclopentadecen-1-one

Constituent 3

Reference substance name:

(4E)-3-Methyl-4-cyclopentadecen-1-one

Cas Number:

62221-84-5

Molecular formula:

C16 H28 O

IUPAC Name:

(4E)-3-Methyl-4-cyclopentadecen-1-one

Test material form:

liquid

Details on test material:

- Physical state: colourless liquid
- Reception date: 1991-06-27
- Storage condition of test material: in the dark at about 4°C

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR strain (VAF plus)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate Kent
- Age at study initiation: 10-11 weeks
- Weight at study initiation: M: 249-266 g; F:230-245g
- Fasting period before study: no
- Housing: individually housed in grid bottomed cages suspended over cardboard lined excreta trays.
- Diet (e.g. ad libitum): pelleted rodent diet ad libitum (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 55-65 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no data
- Type of wrap if used: pad of surgical gauze 4 plies thick overlaid with a strip of aluminium foil and secured in position by a length of 5.0 cm wide 'Elastoplast' elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: approximately 30 minutes, 1, 2 and 4 hours afters dosing and thereafter for 14 consecutive days.
Weighing: on the day of dosing, on days 8 and 15.
- Necropsy of survivors performed: yes, including opening of the thoracic, abdominal and visceral cavities, and examination of the major organs. Abnormal tissues and organs were preserved in buffered formol saline.

Statistics:

none

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Peri-nasal staining was noted in most animals, onset and recovery occurring earlier in males than in females. Piloerection was also observed in 4 males and 1 female, lasting from one to 5 days.

Gross pathology:

The necropsy findings were consistent with the background macroscopic pathology of this strain of rats:
- Thyroid: reddened appearance in 1 animal (1M)
- Thymus: reddened appearance in 4 animals (2M, 2F)
- Urinary bladder: distended with fluid in 1M and contained white waxy plug in 3M

Other findings:

None

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50Combined > 2000 mg/kg bw

Executive summary:

In a limit acute dermal toxicity study performed according to the OECD guideline No. 402 and in compliance with GLP, groups of young adult Crl:CD(SD) rats (5/sex) were occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality occurred during the study. There was no adverse effect on bodyweight gain.

Peri-nasal staining was noted in most animals, onset and recovery occurring earlier in males than in females. Piloerection was also observed in 4 males and 1 female, lasting from one to 5 days. These effects, considered as mild, were fully reversible. Therefore the test material was considered to be essentially non-toxic at 2000 mg/kg bw.

 

Dermal LD₅₀Combined > 2000 mg/kg bw

Under the test conditions, the test material 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.