Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD test guideline 402)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Description: blue powder
- Expiration date of the batch: 01-Apr-1997
-Stability under storage conditions: stable

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd, Basel, Switzerland
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: 234-261 g (males), 175-181 g (females)
- Housing: individually, in polycarbonate cages
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: 25 cm² for males, 18 cm² for females
- Type of wrap: aluminium foil and flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed at the end of the treatment period with a tissue moistened with water

TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: twice daily for mortality; at periodic intervals on day 1 and once daily thereafter for general clinical signs
- Frequency of weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was noted at the limit dose level.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No test item-related clinical signs were noted.
Body weight:
Low or no body weight gain was noted among 5/10 rats and body weight loss was observed in 3/10 rats over the first week of the observation period. Improved body weight gain was observed in all animals over the second week.
Gross pathology:
At necropsy, bluish discolouration of the epidermis in the treated skin area and of the tail and abdominal fat was observed.
Other findings:
Treated skin abnormalities:
No skin irritation was observed on the treated area during the observation period. Snout, tail, treated skin area and the surrounding skin area were discoloured bluish by the test item.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU