Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22. 8. – 8. 9. 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
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 Yellow 124
Substance type: organic
Physical state: liquid
Appearance: dark yellow viscous liquid

Composition of test material, percentage of components:
- Analytical purity: 90.0 % (w/w)
- Impurities (identity and concentrations):
4´-[2-((hydroxy)ethyl)ethylamino]azobenzene 3.0 % (w/w)
1,1-bis(N-ethyl[4-(phenylazo)phenyl]aminoethan-2-oxy)ethan 2.5 % (w/w)
- Unknown impurities 4.5 % (w/w)

Lot/batch No.: S2408
Expiration date of the lot/batch: Unlisted
Stability under test conditions: stable
Storage condition of test material: During the study the test substance was stored in glass bottle at laboratory temperature.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Weight at study initiation: 223g (206-242) males, 152 g (143-167) females
- Housing: animal room with monitored conditions – one animal in one plastic cage
- Diet (e.g. ad libitum): ST 1 BERGMAN – 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: 6x6 cm
- % 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): by 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 h
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 males and 5 females
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
Mortality: daily
Clinical signs: daily

- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
The study was performed as limit test: two groups of animals – 5 males and 5 females and the dose of 2000 mg/kg. The pre-test was performed with 1 male and 1 female of those groups of the five animals. The pre-test was started one day before the start of limit test.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
Clinical signs of toxicity – diarrhoea and gibbous posture were observed to the 3rd day of the study and skin around anus coloured by excrements were observed to the 4th day of the study and to the 5th day of the study in pilot animals.
Body weight:
In males and females, the weight increments were adequate to species and age of animals in the experiment.
Gross pathology:
Macroscopic changes - fat in abdominal cavity coloured light yellow in all males and fat in abdominal cavity coloured yellow in all females, were diagnosed during pathological examination in all animals.

Any other information on results incl. tables

Because of mild character of clinical and macroscopic effects it was concluded that they did not influence the classification of the test substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results of study, the value of LD50 (dermal) of the test substance, Solvent Yellow 124, for rats of both sexes is higher than 2000 mg/kg of body weight.
Because of mild character of clinical and macroscopic effects it was concluded that they did not influence the classification of the test substance.
Executive summary:
The test substance, Solvent Yellow 124, was tested for acute dermal toxicity using Wistar rats.

 

Testing was performed according to Method B.3 - Acute toxicity (Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

- 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 pre-test was performed with 1 male and 1 female from each group. After end exposure test substance of these pilot animals, the other animals of the group were dosed.

The test substance was applied on the shaved skin of the test animals in delivered form for 24 hours.

The test animals were observed 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 - diarrhoea and gibbous posture were observed to the 3rd day of the study and skin around anus coloured by excrements were observed to the 4th day of the study and to the 5th day of the study in pilot animals.

One macroscopic change was diagnosed during pathological examination of all animals – light yellow fat in abdominal cavity in males and yellow fat in abdominal cavity in females.

    

According to the results of study, the value of LD50 (dermal) of the test substance, Solvent Yellow 124, for rats of both sexes is higher than 2000 mg/kg of body weight.

Because of mild character of clinical and macroscopic effects it was concluded that they did not influence the classification of the test substance.