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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:
experimental study
Adequacy of study:
supporting study
Study period:
1981, not specified.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP. Reported under EC 793/93 for Existing substances regulations. Full methodology etc not available. Deemed reliable as evaluated by the European Commission. This data is considered the property of the data submitter. However it has not been possible to locate the study report due to re-organisation associated with the merger.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Kronitex 50
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: not specified
- Physical state: not specified
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals

Species:
rat
Strain:
other: F3 hybrid of RII 1/Tif and RII 2/tif
Sex:
male/female
Details on test animals and environmental conditions:
Not specified.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on exposure:
5 rat/sex/group were patched with the test substance dermally on the shaved back for a period of 4 weeks on a 5 day/week basis, 6 hours per day.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
Not specified.
Duration of treatment / exposure:
28 days
Frequency of treatment:
5 days/week for for weeks, 6 hours/day
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/kg
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
500 mg/kg
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
2000 mg/kg
Basis:
nominal per unit body weight
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
5 rat/sex/group were patched with the test substance dermally on the shaved back for a period of 4 weeks on a 5 day/week basis, 6 hours per day. No further information is available.
Positive control:
Not specified.

Examinations

Observations and examinations performed and frequency:
Not specified.
Sacrifice and pathology:
Not specified.
Other examinations:
Not specified.
Statistics:
Not specified.

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
not specified
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:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
There was a slight inhibition of plasma cholinesterase activity in females receiving 500 mg/kg (p<0.01) as well as in both sexes of the 2000 mg/kg group (male not significant, female significant at p<0.01). The erythrocyte cholinesterase activity was significantly (p<0.01) inhibited in the males treated with 2000 mg/kg. Adrenal weights were increased in males receiving 500 and 2000 mg/kg. Microscopic examination of tissues showed a slight fatty change in the adrenal cortex in 2/5 males receiving 500 mg/kg and in 3/5 males receiving 2000 mg/kg.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day
Sex:
male
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Sex:
female
Dose descriptor:
LOEL
Effect level:
500 mg/kg bw/day
Sex:
male
Dose descriptor:
LOEL
Effect level:
2 000 mg/kg bw/day
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The No Adverse Effect Level was 100 mg/kg in males and 500 mg/kg in females. The Low Observed Effect Level in males was 500 mg/kg and 2000 mg/kg in females.
Executive summary:

The No Adverse Effect Level for Kronitex 50 in this test was 100 mg/kg in males and 500 mg/kg in females. The Low Observed Effect Level in males was 500 mg/kg and 2000 mg/kg in females.

This information is provided as supporting study data only.