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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of the test chemical in rabbits.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
EC Number:
228-783-6
EC Name:
Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
Cas Number:
6358-69-6
Molecular formula:
C16H10O10S3.3Na
IUPAC Name:
trisodium 8-hydroxypyrene-1,3,6-trisulfonate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Trisodium 8-hydroxy-1,3,6-pyrenetrisulfonate
- Molecular formula : C16H10O10S3.3Na
- Molecular weight : 524.389 g/mol
- Smiles notation : c12c3c4c(cc(c3ccc2c(S([O-])(=O)=O)cc(c1cc4)S([O-])(=O)=O)O)S([O-])(=O)=O.[Na+].[Na+].[Na+]
- Substance type:Organic
- Physical state:Solid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill, Ltd., UK)
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing:The animals were conventionally kept in single cages
- Diet (e.g. ad libitum): appropriate diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data available

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g of the test sample diluted with water
Duration of treatment / exposure:
24 hours
Observation period:
24, 48 and 72 hours till 7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: shaven back skin
- % coverage: no data available
- Type of wrap if used: on a plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: After removing the dressing, the exposed areas of the skin were washed with soap and water

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 24, 48 and 72 hours till 7 days

SCORING SYSTEM:
- Method of calculation: Draize method
The findings were collected 24 and 72 hours after the end of exposure, even after 7 days. The extent of erythema or edema formation according to DRAIZE (see evaluation table) and all other conspicuous findings were recorded.
The back skin not treated with the test pattern served as a control.
Rating table

Erythema - redness
- no redness O
-light, barely perceptible redness 1
~ well noticeable retention (low to moderate) 2
~ moderate to strong retention 3
- deep redness, partly disposition u
edema - swelling
- no swelling 0
-very slight, barely perceptible swelling 1
- slight swelling (margins well demarcated) 2
- moderate swelling (edges approx. 1mm raised) 3
- strong swelling (margins larger than 1mm raised, extension over exposure site) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test chemical was considered not irritating to rabbit skin

Any other information on results incl. tables

Table- Primary dermal irritation/corrosion

Rabbit number

Draize scores

Stimulus values

 

1 h

24h

48h

72h

7 days

14 days

 

 

Er

Od

Er

Of

Er

Od

Er

Od

Er

Od

Er

od

 

Mean (ER)

Mean (od)

152

-

-

0

0

-

-

0

0

0

0

-

-

0

0

153

-

-

0

0

-

-

0

0

0

0

-

-

0

0

157

-

-

0

0

-

-

0

0

0

0

-

-

0

0

158

-

-

0

0

-

-

0

0

0

0

-

-

0

0

160

-

-

0

0

-

-

0

0

0

0

-

-

0

0

161

-

-

0

0

-

-

0

0

0

0

-

-

0

0

Er- erythema, od- edema, - = no reactions observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritaitng
Conclusions:
The mean erythema and edema scores were 0,0 respectively. The test chemical was considered not irritating to rabbit skin
Executive summary:

A study was performed to evaluate the dermal irritation potential of the test chemical in rabbits. 6 rabbits were used for the study. The animals were conventionally kept in single cages and were given an appropriate diet and tap water ad libitum. Only animals with uninjured skin were used.Each animal was given approximately 0.5 g of the test sample diluted with water on a plaster bandage fixed on the shaved back skin. The back skin not treated with the test chemical served as a control.

After removing the dressing, the exposed areas of the skin were washed with soap and water. The exposure time was 24 h. The follow-up time was 7 days.

The findings were collected 24 and 72 hours after the end of exposure, even after 7 days. The extent of erythema or edema formation according to DRAIZE and all other conspicuous findings were recorded.

The mean erythema and edema scores were 0,0 respectively. The test chemical was considered not irritating to rabbit skin