Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2008 - February 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study; the test was conducted on the basis of the official method as defined in the O.E.C.D. guideline N° 402 dated February 24th, 1987 and the test method B.3 of the Council regulation No 440/2008 of 30 May 2008.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 6 weeks (males), 8 weeks (females)
- Weight at study initiation: 217-244 g (males); 201-226g (females)
- Fasting period before study: not reported
- Housing: During the treatment, the animals were kept in individual cage. At 03, the animals were put into their cage by 2 or 3. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): M20-rat/mouse maintenance (Special diets services)
- Water (e.g. ad libitum): tap-water from public distribution system
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%,
- Air changes (per hr): approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (7.00 a.m.- 19.00 p.m.)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: distilled water
Details on dermal exposure:
Topical application, under porous gauze dressing, an effective dose of 2,000 mg/kg body weight of the test substance, diluted in distilled water and administered under a volume of 5 mL/kg body weight, during 24 h.
Duration of exposure:
24 h
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
5 males
5 females
Control animals:
yes
Details on study design:
• Duration of observation period following administration: 14 d
• Frequency of observations and weighing:
1. Daily examination: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test solution. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet. These observations were compared to control data. Observations and a mortality report were then carried out every day for 14 days.
2. Periodical examinations: The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14. Weight changes were calculated and recorded.
• Necropsy of survivors performed: yes. Examination at the end of the test: On D 14, the animals were anaesthetized with sodium pentobarbital and administration continued to fatal levels. Maeroscopie observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
• Necropsy of survivors performed: yes.

Statistics:
No data given in the test report

Results and discussion

Preliminary study:
No preliminary study was conducted.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (rat, dermal) of the test item is > 2,000 mg/kg body weight.
Executive summary:

The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2,000 mg/kg body weight.

No mortality occurred during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment related changes.

In conclusion, the LD50of the test item is higher than 2,000 mg/kg body weight by dermal route in the rat.