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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
data is from experimental reports

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
To assess the dermal irritation parameter of the test chemical in accordance with OECD 404
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenediamine, salt with phosphoric acid
EC Number:
238-914-9
EC Name:
Ethylenediamine, salt with phosphoric acid
Cas Number:
14852-17-6
Molecular formula:
C2H8N2.xH3O4P
IUPAC Name:
ethane-1,2-diamine; phosphoric acid
Test material form:
solid: particulate/powder
Details on test material:
Name of the test chemical: ethylenediamine, salt with phosphoric acid
Molecular Formula: C2H11N2O4P
Molecular Weight: 158.094 g/mol
Physical State: Solid, White powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: female
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 1.80kg±200g
- Housing: Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
- Identification: By cage tag and corresponding colour body marking
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav agro Industries Ltd., Delhi
- Water (e.g. ad libitum): Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum
- Acclimation period:The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
- Randomization: After acclimatization and Veterinary examination three females were randomly selected.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Air conditioned rooms with temperature between 22-250C
- Humidity (%): elative 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

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 gm of test compound
Duration of treatment / exposure:
4 hours
Observation period:
60 min., 24, 48 and 72 hours after application.
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: small area (approximately 6 cm2) of intact skin site
- Type of wrap if used: impervious occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: After patch removal, the dressing and unabsorbed test product was removed and the site of application was cleaned with lukewarm water.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 60 min., 24, 48 and 72 hours after application.

SCORING SYSTEM:
- Method of calculation: The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Skin reaction
The test chemical applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit did not produce any clinical signs of irritation to skin during period of observation. The duration of application of test compound was 24th hour.

Other effects:
Clinical Signs
The test chemical applied on the shaven back skin of rabbit in the amount of 0.5 gm did not produce pain and any clinical signs of toxicity throughout the examination period of 14 days.

Any other information on results incl. tables

INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES

 

Rabbit No.

Sex

INTACT SKIN

3 Min.

4 Hours

24 Hours

48 Hours

72 Hours

14 days

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

01

F

0

0

0

0

0

0

0

0

0

0

0

0

02

F

-

-

0

0

0

0

0

0

0

0

0

0

03

F

-

-

0

0

0

0

0

0

0

0

0

0

Total

0

0

0

0

0

0

0

0

0

0

0

0

Mean

0

0

0

0

0

0

0

0

0

0

0

0

Grand Total

0.00

 

Dermal Irritation Index: 0.0/4 = 0.0

CLINICAL SIGNS

SEX

ANIMAL NO.

Time (Min.)

Time (Hours)

Time (Day)

3

1

4

24

48

72

14

 

FEMALE

 

01

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

 

N: No Clinical Signs

C: Clinical Signs Observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The test chemical applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit did not produce any clinical signs of irritation to skin during period of observation. The overall irritation score was calculated to be 0.00. Hence, the test chemicalk can be considered to be not irritating to skin. It can be classified under the category "Not Classified".
Executive summary:

A dermal irritation study was conducted on female New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of the test chemical.

In the initial test one healthy rabbit of body weight 1.80kg±200gm was selected for the study after acclimatization. The test compound in the amount of 0.5 gm was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment.

The test substance in the amount of 0.5 gm was applied to a small area (approximately 6 cm2) of skin and covered with a gauze patch, which was held in place with non irritating tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. No skin reaction was observed after four hours patch removal.Finally, the animal was observed for 14 days, for any irritation and corrosion.

Because no corrosive effect observed in the initial test, a confirmatory test was done in order to confirm the irritant or negative response of the test substance by using two additional animals. In the confirmatory test the test compound in the amount of 0.5 gm was applied on the shaven back skin of two animals, each with one patch, for an exposure period of four hours.

The test chemical applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit did not produce any clinical signs of irritation to skin during period of observation. The overall irritation score was calculated to be 0.00. Hence, the test chemical can be considered to be not irritating to skin. It can be classified under the category "Not Classified".