A mixture of cis- and trans-cyclohexadec-8-en-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-08-12 to 1987-03-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

According to OECD 402 and GLP, but individual animal results not provided in the report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

According to OECD 402 and GLP, but individual animal results not provided in the report.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

EC Number:

401-700-2

EC Name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

Cas Number:

3100-36-5

Molecular formula:

C16H28O

IUPAC Name:

(8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both sexes were investigated
- Age at study initiation: Young adult
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front. Throughout the 24-hour exposure period the animals were kept in restraining boxes.
- Diet: Ad libitum (standard laboratory rabbit diet), except for 24 hours exposure period
- Water: Ad libitum
- Acclimation period: Approx. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): At least 40
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 15

Administration / exposure

Vehicle:

unchanged (no vehicle)

Remarks:

The test substance was melted at approx. 35°C

Details on dermal exposure:

TEST SITE
- % coverage: Approx. 10
- Type of wrap used: The treated skin area of the rabbits was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed from the skin with an appropriate solvent.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5 mL/kg bw
- Concentration: The test substance was applied in pure form
- Constant volume or concentration used: No

Duration of exposure:

24 hours

Doses:

5 mL/kg bw

No. of animals per sex per dose:

5 animals per sex were treated with a single dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded on day 0 (day of dosing), 8 and 15 (day of autopsy). Mortality was recorded with the time and cause of death as precisely as possible.
- Necropsy of survivors performed: Yes
- Clinical signs including body weight: All visible reactions to treatment observed during the 24-hour exposure period and during the subsequent two-week period were recorded.
- Other examinations performed: Clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 600 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No rabbits died during the 24-hour exposure period. On day 2, one rabbit was found dead.

Clinical signs:

other: Local effects: During and/or at the end of the 24-hour exposure period treatment-related dermal effects consisted of slight erythema and slight oedema. The following local skin reactions were recorded for all rabbits during the 14-day observation period:

Gross pathology:

The autopsy findings in all animals (also in the animal that died) were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo acute dermal toxicity study in rabbits according to OECD guideline 402, the LD50 was higher than 4600 mg/kg bw.

Executive summary:

A sample of the test substance was examined for its acute dermal toxicity in a limit test with albino rabbits according to OECD guideline 402 and GLP. Five male and five female rabbits were dermally treated with 5.0 mL/kg body weight. The exposure period was 24 hours. Acute local skin reactions consisted of slight erythema and slight oedema. At the end of week 1, moderate to severe scaliness and some slight incrustation were observed, and at the end of week 2 (at autopsy), slight to severe scaliness. The only sign of acute toxicity consisted of slight apathy which was observed in two rabbits. One male rabbit died but autopsy findings were normal. There was some growth retardation during week 1 but during week 2, growth was normal. Apart from the slight local skin effects mentioned above, terminal autopsy findings were normal. On the basis of the results obtained, it was concluded that the substance is not considered to be harmful in contact with skin, the dermal LD₅₀ value being higher than 4600 mg/kg bw (5.0 mL/kg bw).