Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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Reference
Endpoint:
acute toxicity: oral
Data waiving:
exposure considerations
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 July, 2011
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Skin preparation:
24 hours before the beginning of the test the back and the sides of the animals have been shaved on an area of about 20 cm2.
Application:
The test sample has been given, a ratio of 2000 mg/kg, with a square of gauze directly on animals' skin humidified with sodium chloride injection and fixed with a skin patch in a area of about 10% of the total body surface.
the square has been put on the back of animals and further fixed with hypo-allergenic occlusive adhesive tape.
The whole trunk of the animal has been protected with an elastic bandage. Bandage has been left in situ for 24 hours, during this period animals have been kept in single cages.
Removal:
24 hours after application bandage and adhesive tape have been remove.
Skin has been cleaned from sample excess by a tampon soaked in physiological solution.
Duration of exposure:
24 hours
Doses:
The test sample has been given, a ratio of 2000 mg/kg, with a square of gauze directly on animals' skin humidified with sodium chloride injection and fixed with a skin patch in a area of about 10% of the total body surface.
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
not specified
Details on study design:
Observations
The general status of all animals has been daily monitored after 1-3-5 hours from the start of treatment and daily (5 days per week) for 14 days.
All activies related to the study, as well as remarks and exams have been daily registered in dated and signed forms.
During the study the following observations have been done:
- Mortality
Animals have been observed in the morning of each working day (5 days/week).
- Clinical symptomatology
Every clinical symptom, including possible variations of somato-motory activity, was daily registered for each individual animal.
Clincial observations included a general objective exam (G.O.E.) above:
1.assessment of major organic functions;
2. assessment of the status of integumentary apparatus;
3. assessment of the status of mucosae;
4. assessment of somato-motory activity and of the sensory status.
- Body weight
Animals have been weighted before experiment, after 7 days and at the end of the experiment.
- Post mortem
At the end of the observation period, animals have been sacrificed and a post-mortem examination has been carried out.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
During the study no mortality was detected.
Clinical signs:
During the study neither symptoms nor signs of toxicity were recorded.
Body weight:
Treated animals' weight was complied with the stardard of species and race in first and in the second week of the study.
Following table shows weight increases of individual treated animals:

MALE RATS (No) WEIGHT INCREASE (g) FEMALE RATS (No) WEIGHT INCREASE (g)
1 129 1 41
2 119 2 34
3 98 3 42
4 95 4 55
5 118 5 42
Other findings:
- Post mortem observations
At the autopsy no abnormalities have been detected.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance has a LD50 > 2000 mg/kg bw and can be considered NOT TOXIC - NOT HARMUFUL.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification