Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.