1'-acetonaphthone

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from NTRL report

Data source

Reference

Reference Type:

secondary source

Title:

Basic toxicity of 1-acetonaphthalene in rats and mice with cover letter dated 06/10/92

Author:

D. C. Topping

Year:

1992

Bibliographic source:

NTRL OTS0537531, Updated at June 10 1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of 1- Acetonaphthalene

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1'-acetonaphthone

EC Number:

213-384-1

EC Name:

1'-acetonaphthone

Cas Number:

941-98-0

Molecular formula:

C12H10O

IUPAC Name:

1'-acetonaphthone

Details on test material:

- Name of test material: 1- Acetonaphthalene
- Molecular formula: C12H10O
- Molecular weight: 170.21 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): No data

Test animals

Species:

guinea pig

Strain:

not specified

Details on species / strain selection:

No data

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

open

Vehicle:

not specified

Details on exposure:

TEST SITE
- Area of exposure: Clipped backs
- % coverage: No data
- Type of wrap if used: No data
- Time intervals for shavings or clipplings: No data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): No data
- Constant volume or concentration used: No data
- For solids, paste formed: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data

USE OF RESTRAINERS FOR PREVENTING INGESTION: No data

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

10 days

Frequency of treatment:

Daily

Doses / concentrations

Remarks:

0.5mL (557.2 mg/kg)

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

No data

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data

DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: No data

BODY WEIGHT: No data
- Time schedule for examinations: No data

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No data
- Time schedule for examinations: No data

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data - Animals fasted: No data - Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER: No data

Sacrifice and pathology:

GROSS PATHOLOGY: No data
HISTOPATHOLOGY: No data

Other examinations:

No data

Statistics:

No data

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Dermal irritation:

effects observed, treatment-related

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Details on results:

Clinical signs and mortality
Clinical signs: Slight exacerbation was noted upon repeated application

Mortality: No data

Dermal irritation: Slight erythema was noted in 4/5 guinea pigs on day 1 and slight to moderate erythema in 5/5 and edema and/or vesicles in 4/5 guinea pigs after 2 weeks.

Body weight and weight gain: No data

Food consumption and compound intake: No data

Food efficiency: No data

Water consumption and compound intake: No data

Opthalmoscopic examination: No data

Haematology: No data

Clinical chemistry: No data

Urinanalysis: No data

Neurobehaviour: No data

Organ weights: No data

Gross pathology: No data

Histopathology: No data

Effect levels

Dose descriptor:

NOAEL

Effect level:

557.2 other: mg/Kg

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Slight exacerbation, erythema and edema formation was observed

Remarks on result:

other: No toxic effects were observed

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

The No Observed Adverse Effect level (NOAEL) for test chemical was considered to be 0.5mL (557.2 mg/kg) when applied to the clipped backs of guinea pigs.

Executive summary:

Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of test chemical . Uncovered application of 0.5mL (557.2 mg/kg) of the test compound was applied daily for 10 days to the clipped backs of 5 guinea pigs. The animals were observed for dermal irritation. Slight exacerbation was noted upon repeated application. Slight erythema was noted in 4/5 guinea pigs on day 1 and slight to moderate erythema in 5/5 and edema and/or vesicles in 4/5 guinea pigs after 2 weeks. However, the report mentions no percutaneous absorption at 20mL/Kg dose (22288 mg/Kg bw/day) in acute dermal toxicity study performed. Since the no percuteaneous absorption acute dermal dose of 22288 mg/Kg bw/day is greater than the repeated dose dermal toxicity dose (557.2 mg/Kg bw) and hence on this basis, the No Observed Adverse Effect level (NOAEL) for 1- Acetonaphthalene is considered to be 0.5mL (557.2 mg/kg) when applied to the clipped backs of guinea pigs.