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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
Basic subacute 28 d repeated dose toxicity study with dermal administration of test substance
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): R-300 (Diisopropylnaphthalene)
- no further information on test substance

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on exposure:
Route of administration: dermal; test substance was applied on shaved skin of the back of rats (no further information)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
28 d
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
not specified
Basis:

No. of animals per sex per dose:
no data
Control animals:
not specified

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: daily

FOOD CONSUMPTION: Yes
- Time schedule for examinations: daily

FOOD EFFICIENCY: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Time schedule for collection of blood: before the start and at the end of the experiment
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters examined: conventional hematological parameters

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: before the start and at the end of the experiment
- Animals fasted: No data
- How many animals: No data
- Parameters examined: total serum protein, blood urea nitrogen (BUN), serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), no further information

URINALYSIS: Yes
- Time schedule for collection of urine: before the start and at the end of the experiment
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: conventional urinary examination

NEUROBEHAVIOURAL EXAMINATION: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes, complete autopsy; various organ weights were determined.
HISTOPATHOLOGY: Yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
385 mg/kg bw/day
Sex:
not specified
Basis for effect level:
other: no data

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In a dermal 1 month repeated dose toxicity study, a NOAEL of 385 mg/kg bw/day was derived for DIPN under the test conditions used.