Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Skin irritation / corrosion

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

Test material information

Constituent 1

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-trisulphonate

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

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