Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/07/2015-05/08/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Sponsor's identification : MADERAL ZA1076 ; code number : PH-15/0488
Date received : 08/07/2015
Container glass flask (x1)
Date of received: 08/07/2015
Container: glass flask (x1)
Quantity: 118.10 g (container + content)
Batch: 100026324
Production date: 11/03/2015
Form: liquide
Colour: colourless
Storage: room temperature / darkness
Expiry date: 10/03/2016

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Type: 5 males and 5 females
Source: Elevage JANVIER LABS
Acclimatation period: at least 5 days
Rate of air exchange: at least 10 changes cycle per hour
Photoperiod : 12h light (7.00 to 19.00) / 12h darkness
Age of the rat at the beginning of the study : Male : 7 weeks old ; Female : 8 weeks old
Identification: by numbered ring on the edge of one ear

Housing :
Number of rat / cage : At the beginning : 1 / cage
D1 : 5 / cages
Cages : solid-bottomed clear polycarbonates cages with a stainless steel mesh lid. Contained dust free weed shaving which were changed at least 2 times a week.
Temperature : 19-25°C
Relative humidity : 30-70%

Food and drink supplied freely :
Drink water : tap-water from public distribution (which microbiology and chemistry is analysed every 6 months by Eurofins IPL, Bordeaux)
Foodstuff: SAFE-A04

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test site:
10% of the body was clear from fur clipping, 24h before the treatment
Duration of exposure:
24h
Doses:
2000 mg/kg body weight
Control animals:
yes
Remarks:
10 animals (5 males and 5 females) received by topical application, an effective dose of 10 ml/kg body weight of the control item distilled water, under porous gauze dressing, during 24h.
Details on study design:
Daily examination: identification of behaviour/toxic effect on the major physiological function during 14 days following the administration of the test item. Data compared to historical control data. Mortality was also reported.

Periodical examination: Weight examination: On D0 (before administering the test item) ; D2 ; D7 ; D14

Examination at the end of the test: On D14, animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were noted. Only organs likely to be modified in case of acute toxicity were examined. No organ was removed and preserved in view to microscopic examination
Statistics:
Not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study
Clinical signs:
No systemic clinical signs related to the administrations of the test items were observed
Slight erythema was noted on the treated area in females of treated group, 48h post-dose. The skin recovered a normal aspect on day 5.
Body weight:
The body weight evolution of the animal remained normal throughout the study
Gross pathology:
the macroscopic examination of the animals at the end of the study did not reveal treatment-related changes

Any other information on results incl. tables

Deviations :

A relative humidity higher than 70% was registered on 05/08/2015. The maximum value measured was 71%. It is considered as without impact on the conclusion of the study

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 2000 mg/kg body weight by dermal route in the rat
Executive summary:

The acute dermal toxicity was performed according to the OECD Guideline 402 (Acute Dermal Toxicity).

The results are the following:

LD50 > 2000 mg/kg body weight by dermal route in the rat