Hydroxycyclohexyl phenyl ketone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Aug. 26, 1981 to Sep. 8, 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxycyclohexyl phenyl ketone

EC Number:

213-426-9

EC Name:

Hydroxycyclohexyl phenyl ketone

Cas Number:

947-19-3

Molecular formula:

C13H16O2

IUPAC Name:

1-benzoylcyclohexan-1-ol

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF strain)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Random bred rats raised on the premises (CIBA-GEIGY Limited, Exp. Toxicology Sisseln GU 2.1)
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: 208 +/-6.7 g for males and 174 +/- 13.8 g for females
- Fasting period before study: Not reported
- Housing: Housed individually in Macrolon cages (type 2)
- Diet (e.g. ad libitum): ad libitum, rat food (NAFAG No. 880, NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Distilled water containing 0.5% carboymethylcellulose and 0.1% Tween 80

Details on dermal exposure:

TEST SITE
- Area of exposure: on the back of the animals
- % coverage: Not reported
- Type of wrap if used: For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mL/kg body weight
- Concentration (if solution): Not reported

Duration of exposure:

24 hours

Doses:

5,000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Signs and symptoms, mortality, and skin irritation parameters (erythema, edema, and necrosis) were observed at 1, 2, 3, 5, and 24 hours, and then daily each day up to a period of 14 days. Body weights were recorded immediately prior to dosing and at 7 and 14 days.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no deaths reported

Mortality:

No deaths were reported.

Clinical signs:

other: Dyspnea, exophthalmos, ruffled fur and curved body position. These clinical signs are common effects in this type of study. All animals recovered within nine days.

Gross pathology:

No gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 5000 mg/kg bw

Executive summary:

In this guideline (OECD 402) comparable study, the acute, dermal LD50 of the test material to rats was determined to be >5000 mg/kg bw. 10 rats (5 male, 5 female) were exposed dermally to the test material (occlusive conditions) for 24 hours, and then observed for 14 days. No mortality was observed, and no treatment related effects were reported. Based upon this test result the test material does not meet the criteria for classification as acutely toxic under the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).