3,3'-thiodi(propionic acid)

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

- Name of test material (as cited in study report): 3,3´-Thiobispropanoic acid
- Analytical purity: 99.5 %
- Lot/batch No.: NT-463

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-thiodi(propionic acid)

EC Number:

203-841-3

EC Name:

3,3'-thiodi(propionic acid)

Cas Number:

111-17-1

Molecular formula:

C6H10O4S

IUPAC Name:

3-[(2-carboxyethyl)sulfanyl]propanoic acid

Details on test material:

- Name of test material (as cited in study report): 3,3´-Thiobispropanoic acid
- Analytical purity: 99.5 %
- Lot/batch No.: NT-463

Test animals

Species:

rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: The animals were individually housed in supended cages.
- Diet (e.g. ad libitum) + Water (e.g. ad libitum): Free access to mains drinking water and food
- Acclimation period: 5 days




ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Amount / concentration applied:

TEST MATERIAL
- Concentration: 0.5 g of test material moistened with 0.5 ml of distilled water.

Duration of treatment / exposure:

one patch was removed at each time of three time points: 3 minutes, 1 hour and 4 hours after application.

Observation period:

One hour following the removal of the patches, and 24, 48 and 72 hours later, the test sides were examined for evidance of primary irritation.

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: shorn skin
- % coverage: 2.5*2.5 cm
- Type of wrap if used: a strip of surgical adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.



SCORING SYSTEM: Draize classification scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Individual Skin reaktions (3 minutes and 1 hour):

Skin Reaction	Observation Time	Individual scores- Rabbit Number and Sex
		65966 Male
		3-minutes exposure		1 hour exposure
Erythema/Eschar Formation	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0		0 0 0 0
Odema formation	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0		0 0 0 0

Individual skin reaktion (4 -hour exposure):

Skin Reaction	Observation Time	Individual scores- Rabbit Number and Sex
		65966 male	65983 male	65985 male
Erythema/Eschar Formation	1 hour 24 hours 48 hours 72 hours	1 0 0 0	1 0 0 0	1 0 0 0
Odema formation	1 hour 24 hours 48 hours 72 hours	1 0 0 0	0 0 0 0	0 0 0 0
Sum of 24 and 72 hour readings: 0
Primary Irritation Index 8S/6): 0/6 = 0.0
Classification: NON IRRITANT

The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

not irritating to skin (OECD TG 404)

Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 (July 17, 1992), 3 young adult New Zealand white rabbits were dermally exposed to 0.5 g of 3,3´-Thiobispropanoic acid moistened with 0.5 ml of distilled water to 2.5 x 2.5 cm² skin surface for 3 minutes, 1 hour and 4 hours under semiocclusive conditions. Animals then were observed for 72 h. Irritation was scored by the method of Draize. 

After 3 min and 1 hour exposure erythema and edema scores were 0 at all observations. After 4 h exposure very slight erythema (grade 1) was present in all tree animals, and very slight edema (grade 1) in 1/3 animals. These effects were reversible within 24 h. No other signs of irritation were observed during the study.

In this study 3,3´-Thiobispropanoic acid is classified as not irritating to rabbit skin according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).