Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22.8.2012 - 8.9.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Solvent Red 19E
- Physical state: dark viscous liquid/borderline waxy solid
- Analytical purity: 90% (w/w)
- Impurities (identity and concentrations): Solvent Red24 (CAS 85-83-6) 2% (w/w)
- Lot/batch No.: S2409
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: in well closed original container at the temperature bellow 25°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 195-237 g (males), 157-162 g (females)
- Housing: Animal room with monitored conditions – one animal in one plastic cage with sterilised soft wood shavings.
- Diet (e.g. ad libitum): standard pelleted diet ad libitum
- Water (e.g. ad libitum): Drinking tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Relative humidity (%): 30-70 %
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): Light: 12 hour light/12 hour dark

STUDY TIME SCHEDULE
Experimental starting date: 22.8.2012
Experimental completion date: 8.9.2012

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Approximately 24 hours before application, a skin area of approximately 6 x 6 cm on the back of the animals was shaved.
- % coverage: aprox. 10 % of the body surface
- Type of wrap if used: The application site was covered by mull and held in contact by plaster (strapping).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remains of the test material was wiped off with water.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): According to its body weight and the dose.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 males and 5 females.
A pre-test was performed with 1 male and 1 females of those groups of 5 animals.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Body weight: Before application, 8th and 15th day of study. body weight increments were calculated from the body weight at the start of the study, during the first week and at the end of the study.
- Mortality: daily
- Clinical signs: After application, the animals were observed individually. On the first day observations were made twice, 30 minute and three hours after application. On the second day observations were made twice, in the morning and afternoon, and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, visible mucous membranes, nutritive condition, autonomic and central nervous systems, psychic activity, somatomotor activity, reactions to stimuli, function of respiratory, circulatory, digestive and urogenital system. Also, presence of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma were carefully observed.

- Necropsy of survivors performed: All test animals surviving to the end of study were sacrificed on the 15th day by injection of veterinary preparation T61 (1 mL i.v.) and gross necropsy was carried out. Nutritional state, body surface, body foramina, thoracic, abdominal and cranial activity were evaluated. All gross macroscopic changes of organs and tissues were recorded.

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:
There were no deaths.
Clinical signs:
Clinical signs of toxicity - diarrhoea were observed to the 3rd day of the study, gibbous posture were observed to the 4th day of the study and skin around anus coloured by excrements persisted to the 5th day of the study.
Body weight:
In males and females, the weight increments were adequate to species and age of animals in the experiment.
Gross pathology:
No macroscopic changes were diagnosed during pathological examination of all animals.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (EU criteria)
Conclusions:
The LD50 (dermal) of the test substance for rats of both sexes is higher than 2000 mg/kg of body weight.
Executive summary:

The test material was assessed for acute dermal toxicity according to Method B.3 - Acute toxicity (Dermal), Council Regulation (EC) No.440/2008, and according to OECD Test Guideline No.402 - Acute Dermal Toxicity, Adopted 24th February 1987. 

The study was performed as limit test: Two groups of animals – 5 males and 5 females at the dose of 2000 mg/kg of body weight. The test substance was applied on the shaved skin of the test animals in delivered form for 24 hours.

The test animals were observed for 14 days after exposure test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed.

The test substance applied at the dose of 2000 mg/kg of body weight did not cause death of animals. Clinical signs of toxicity were observed, notably diarrhoea was observed to the 3rd day of the study, gibbous posture were observed to the 4th day of the study and skin around anus coloured by excrements persisted to the 5th day of the study.

No macroscopic changes were diagnosed during pathological examination.

According to the results of study, the value of LD50 (dermal) of the test material, for rats of both sexes > 2000 mg/kg of body weight.