cyclohexadecanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 27 Feb 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

occlusive instead of semi-occlusive dressing

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

yes

Remarks:

occlusive instead of semi-occlusive dressing

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(Commission Directive 92/69/EEC)

Deviations:

yes

Remarks:

occlusive instead of semi-occlusive dressing

GLP compliance:

yes (incl. QA statement)

Remarks:

MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

438-930-8

EC Name:

-

Cas Number:

2550-52-9

Molecular formula:

C16H30O

IUPAC Name:

cyclohexadecanone

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 263.8 ± 7.9 g (males), 204.8 ± 8.6 g (females)
- Fasting period before study: no
- Housing: individually in Makrolon Type 3 cages, granulated soft wood bedding
- Diet: ALTROMIN 1324, pelleted standard diet (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 23.5
- Humidity (%): 30 -40, with a shortly falling below to 23
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm shaved skin from the dorsal area of the trunk
- Type of wrap if used: two layers of gaze patch covered with aluminium foil, which was held in contact with the skin by occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: yes, rinsed with corn oil
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 1 mL/100 g bw
- Concentration: 20% (w/v)

VEHICLE
- Amount applied: 1 mL /100 g bw

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 and weighing: The animals were observed for mortality, morbidity and general clinical condition continuously on the day of administration and once daily thereafter (in the morning). The following signs were given predominant consideration: changes in skin, fur, eyes and mucous membranes; gait and posture; respiratory, circulatory, autonomic and central nervous system; occurrence of secretions and excretions; presence of clonic or tonic movements and stereotypies or bizarre behaviour. Body weights were recorded on the day of administration and on days 7 and 14 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight; Skin of administration area was observed for erythema and/or edema one hour after patch removal and once daily thereafter.

Statistics:

Body weights and body weight gain: Calculation of group mean values and standard deviations.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the course of the study.

Clinical signs:

None of the animals showed alterations of the general state of well-being during the course of
the study.

Body weight:

The body weight gain was not affected by the administration of the test item, it was in the range of the historical control data in the testing facility. The body weight gain of one female animal stagnated in the first week but it can be assumed that this is not caused by the administration of the test item and seems to be accidental.

Gross pathology:

There were no macroscopic pathological findings in the animals.

Other findings:

None of the animals showed alterations of the skin on the administration area.

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.

Executive summary:

The acute dermal toxicity of the test substance was assessed in a limit test performed in 5 male and 5 female Wistar rats according to OECD Guideline 402, EU Method B.3 and in compliance with GLP (2001). The test substance was applied at a single dose of 2000 mg/kg body weight to a shaved dorsal area of the trunk of the animals and was then held in contact with the skin with an occlusive dressing for 24 hours. Animals were observed for mortality, general clinical condition and alterations of the administration area (erythema and/or oedema) for a 14-day period. Body weights were recorded on the day of administration and on days 7 and 14 thereafter. Macroscopic examination was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical signs or skin alterations on the administration area were observed. The body weight gain was not affected by the administration of the test item. The body weight gain of one female animal stagnated in the first week but it can be assumed that this is not caused by the administration of the test item and seems to be accidental. No pathological findings were observed at necropsy. Based on the results of this study, the LD50 value for acute dermal toxicity was determined to be > 2000 mg/kg bw in rats.