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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from study report

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity of test chemical in wistar albino rats.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.
- Substance type: Organic
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 200±20g
- Fasting period before study: Animals were fasted overnight prior to test
- Housing: The animals were then housed individually in cages with a collar around the neck in order to avoid the ingestion of the test compound.
- Diet (e.g. ad libitum): food was offered three hours after dosing.
- Acclimation period:The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature between 22-25°C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The test substance was applied uniformly over an exposed area of skin.
- Type of wrap if used: The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
- Time after start of exposure:24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test compound was applied at the dose level of 2000 mg/kg b.w.t as such (as the compound was in liquid form).TEST SITE
- Area of exposure: back skin of total body surface area
- % coverage: Approximate 10 percent
- Type of wrap if used: The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
- Time after start of exposure:24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test compound was applied at the dose level of 2000 mg/kg b.w.t as such (as the compound was in liquid form).
Duration of exposure:
24 hours
Doses:
No. of dose group : Two
Group-I: 2000 mg/kg b.wt (limit test)
Group-II: 2000 mg/kg b.wt (confirmatory test)
No. of animals per sex per dose:
10 (5male & 5 female)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment).
- Necropsy of survivors performed: yes. The necropsy was performed on all animals which was died during the study or were sacrificed at termination of the study.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was recorded in treated rats after administration of test compound at the dose level of 2000 mg/kg b.wt. throughout observation period of 14 days.
Clinical signs:
No any clinical sign of toxicity throughout the observation period of 14 days were observed in treated rat.
Body weight:
The body weight of each animal recorded on day 0, 7th and 14th showed normal increase and there was no significant increase or decrease in weight was recorded.
Gross pathology:
NECROPSY FINDING
EXTERNAL
i.Skin- Skin and hair coat was observed wet.
ii.All external orifices- Normal
B. INTERNAL
i. Subcutaneous- No changes were observed.
ii. Superficial and deep lymph nodes- No change in mesenteric lymph node.
ABDOMINAL CAVITY
i.Opening and general examination- In the abdominal cavity all the organs were present in normal position.
ii.Spleen- No changes were recorded.
iii.Digestive system- No gross changes were observed in stomach and intestine.
iv.Liver and biliary ducts- No gross pathological changes were observed
v.Excretory system- No gross pathological changes were observed.
vi.Adrenal- Observed normal.
vii.Male/female genital organs – Showed normal colour, consistency and no inflammatory changes.
2. THORACIC CAVITY
i.Opening and general examination- Thoracic cavity was found to be normal without any fluid, mucous or blood etc.
ii.Lungs- No changes were recorded.
iii.Heart- No changes were observed in color and consistency. Heart found normal.
iv.Thyroid- Normal in shape, size and surface.
3. CRANIAL CAVITY
i.Brain- Normal in shape and size.
Other findings:
not specified

Any other information on results incl. tables

CLINICAL SIGNS AND MORTALITY

Parameters

Incidence of Clinical Signs Observed after Dosing on

Mortality

Day 0

DAY

Min

Hour

30

1

2

4

6

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Total

%

Mortality (total)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0/10

0

Clinical Signs- Local

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

Redness

-

-

-

-

-

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Pain

-

-

-

-

-

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Swelling

-

-

-

-

-

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Systemic signs

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

-          =Observed after 24 hrs

0        = No clinical signs

+        = Mild

++      = Moderate

+++    = High

++++  = Severe

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The LD50 value was considered to be >2000 mg/kg bw, when Wistar male and female rats were treated with test chemical by dermal application.
Executive summary:

The acute dermal toxicity study was conducted as per OECD Guideline 402 (standard acute method) in Wistar rats. Ten healthy wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test compound was applied at the dose level of 2000 mg/kg b.w.t as such (as the compound was in liquid form) dermally for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals which was died during the study or were sacrificed at termination of the study. No mortality was recorded in treated rats after administration of test compound at the dose level of 2000 mg/kg b.wt. throughout observation period of 14 days. No any clinical sign of toxicity throughout the observation period of 14 days were observed in treated rat. The body weight of each animal recorded on day 0, 7th and 14th showed normal increase and there was no significant increase or decrease in weight was recorded. No gross pathological changes were observed. Therefore, the LD50 value was considered to be >2000 mg/kg bw, when Wistar male and female rats were treated with test chemical by dermal application.