Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 410
Deviations:
yes
Remarks:
results extracted from sub-acute (28 day) study
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Fifty healthy wistar albino rats of both sex, body weight ranging 200±20 gm selected for study. All the selected animals acclimatized for standard laboratory condition for period of one week. After acclimatization animal were divided into five groups (one control and four treated) each having five male and five female. All the animals were prepared 24 hrs prior to application of test compound. The test substance applied uniformly 62.5, 250 and 1000 mg/kg b.wt for at least 6 hours per day on a 7-day per week basis. A reversal group was also maintained in same manner at the highest test dose level 1000 mg/kg b.wt for period of 42 days. The signs of toxicity were recorded as they are observed, including the time of onset, the degree and duration. Cage-side observations viz; changes in skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. All the animals were sacrificed on day 29th of experiment for necropsy examination and histopathological examination of organ and tissue collection was done after completion of study.
Environmental conditions: The animals were kept in air conditioned rooms with 10-15 air circulation cycle per hour, temperature between 22-250C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Dose preparation of pigment violet 27 was done freshly, few minutes prior to dosing. The test substance Pigment Violet-27 was mixed with distilled water to obtain paste. The test substance was applied uniformly daily over an area approximately 10 per cent of the total body surface area in graduated doses for a period ranging from 1-28 days. Between applications the test substance is held in contact with the skin with a porous gauze dressing and non-irritating tape. The test site was covered in a suitable manner to retain the gauze dressing and test substance and ensure that the animals cannot ingest the test substance.
Duration of exposure:
7 days
Doses:
62.5 mg/L, 250, 1000 mg/L
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Group Dose (mg/kg) Treatment 28-Days
Male Female
Group-I Vehicle control 5 5
Group-II 62.5 mg/kg b. wt 5 5
Group-III 250 mg/kg b. wt 5 5
Group-IV 1000 mg/kg b. wt 5 5
Group-V 1000 mg/kg b. wt 5 5
Total nos of animal 25 male & 25 female
Statistics:
The data obtained from present investigation were analyzed by One Way ANOVA and Tukey HSD Test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: NOAEL
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed
Clinical signs:
The treated animals were closely observed for clinical signs of intoxication, first 4 hours and every 1 hrs interval for 24 hrs after dosing and thereafter twice a day for 28 days. All the rats were observed at least twice daily to observe any clinical signs or behavioral changes. These observations included changes in skin and fur, in the eyes and mucous membranes, respiratory, circulatory, central and autonomic nervous systems, somatomotor activity and Behavioral changes. The clinical signs were graded as 0 = Normal, + = Mild, ++= Moderate, +++ =High and ++++ = Severe.
Body weight:
The body weight of each rat was recorded before the start of experiment and after the 7th day
Gross pathology:
During necropsy all the organs viz; Adrenals, Brain, Heart, Kidneys, Liver, Lungs, intestine, Spleen, lymph nodes and Testes of body were examined for gross pathological changes.

Any other information on results incl. tables

There was no dermal irritation observed in the exposed rats at the end of 7 days

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no mortality and no clinical signs of dermal irritation observed in the rats after 7 days of continuous exposure to pigment violet 27 in dose ranging from 62.5 mg/kg bw upto 1000 mg/kg bw. Thus, it can be cioncluded that pigment violet 27 is not acutely toxic to Wistar rat by the dermal route
Executive summary:

There was no mortality and no clinical signs of dermal irritation observed in the rats after 7 days of continuous exposure to pigment violet 27 in dose ranging from 62.5 mg/kg bw upto 1000 mg/kg bw. Thus, it can be cioncluded that pigment violet 27 is not acutely toxic to Wistar rat by the dermal route