Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study poorly documented, small group sizes, study not up to current scientific standards, no data on dose level

Data source

Reference
Reference Type:
publication
Title:
Studio sperimentale sulla tossicità della tetralina e della decalina
Author:
Cardani A
Year:
1942
Bibliographic source:
Medicina del lavoro 33, 145-159; 169-184

Materials and methods

Principles of method if other than guideline:
One male animal was treated twice daily by the dermal route, one female was treated three times daily by the dermal route by rubbing with the test substance.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Administration / exposure

Details on exposure:
Route of Administration: dermal
Duration of treatment / exposure:
16 days
Frequency of treatment:
2 or 3-times daily rubbing in with test substance
Doses / concentrations
Remarks:
Doses / Concentrations:
no precise data
Basis:

No. of animals per sex per dose:
1
Control animals:
no
Details on study design:
Post-exposure period: not applicable

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

TOXIC RESPONSE/EFFECTS: 
- Mortality and time to death: Animals died on days 11 (animal 2) and 16  (animal 1).
- Clinical signs: Piloerection, restlessness, apathy, immobility, and  trembling
- Body weight gain: Weight loss down to 230 and 220 g for animals 1 and  2, respectively
- Food/water consumption: Food consumption reduced
- Haematology: Slight anemia and leucopenia
- Urinalysis: Oliguria, albuminuria, haematuria, increased formation of  urine cylinders, dark staining of urine
- Gross pathology: Skin application area showed squamous and crusted  eczema.
- Histopathology: Toxic centrilobular atrophia of the livers, signed by  hyperaemia, cloudy swelling and fatty degeneration. 

Kidneys of all  animals showed necrotic nephrosis. Lungs showed localised  broncho-pneumonia.

Applicant's summary and conclusion

Conclusions:
A NOAEL was not determined.
Executive summary:

One male and one female guinea pig were treated by the dermal route two or three times per day until the day of death. Treatment was with an unknown dose level by rubbing with cotton wool saturated with tetrahydronaphthalene.

The number of animals and treatment method are insufficient for an assessment.