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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficient data on materials and methods, but study probably not performed under GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material consisted of a colourless liquid contained in a plastic bottle
The test material was received on October 19, 1993 and identificated with entry no. 3427/1.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- The animals were caged in groups of 5 of the same gender in transparent polycarbonate cages (dimensions mm 425X266X180h).
- The housing room was mantained under the following conditions:
x Temperature: 20 ± 2 dC
x Humidity: 55% ± 15% R.H.: Air was changed at least 25 times per hour and maintained at a pressure higher than the outside atmosphere.
x Artificial lighting: 12 h/day.
x The cages and the housing room were cleaned and disinfected before the animals wereaccomodated, then cleaning and disinfection were performed periodically
- Source: "Nossan" - Correzzana MI - ITALY
- Weight at study initiation: 180-200 g
- Fasting period before study: not specified
- Housing: not specified
- Diet: Animals were fed with standard pellet complete diet supplied by the authorized breeder NOSSAN.
- Water: Filtered tap water from local network was supplied ad libitum.
- Quarantine/Acclimation period: Before being used in this study, the animals were kept in quarantine for one week. During this period they were observed daily. At the end of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.
- Animal selection: The animals used for this study were selected randomly from those suitable, available at that time.

Administration / exposure

Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Approximately 24 hours before the test fur was removed by clipping and shaving a dorsal area about 25 cm2 wide.
- The sample was put on a patch (Hansamed strips) the dorsal area of animals. The patch was then covered by an impermeable and hypoallergenic plastic adhesive tape (Blenderm 3M).
- No control group was used.

REMOVAL OF TEST SUBSTANCE
The patch was removed 24 hours after application. The exceeding material was then washed away from skin using a pad soaked in distilled water.

Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
OBSERVATIONS
- General conditions of the animals were controlled daily for 14 days (5 days a week) .
- All data relative to the study, including observations and examination were recorded and signed daily.
- Mortality: Animals were observed in the morning of every working day.
- Clinical signs and behavior: Every clicnical symptom, including possible variations in somotomotor activity, was daily recorded in every single animal. Observations included: tegumentary apparatus, mucosae conditions, respiratory activity and sensorium conditions.
- Body weight: Animals were weighed before the experiment, after 7 days and then at the end of the study.
- Necropsy: At the end of the observation period rats were sacrificed and a necroptic survey was performed.
Statistics:
INTERPRETATION OF RESULTS
Results have been interpreted according to EEC Directives 93/21.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study.
Clinical signs:
No clinical signs were observed during the experimental observation period.
Body weight:
The body weight gain was considered normal for the species and strain of rats used in this study.
Gross pathology:
At the ante-mortem and post-mortem examination in all animals no pathological symptoms were observed. No macroscopic abnormalities were seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results interpreted according to EEC Directives 93/21indicate that the test material, COSMACOL EL, can be considered NON TOXIC and NON
HARMFUL.