2-Thiophenecarboxylic acid, 5-chloro-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-10-28 to 2005-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

22. April 2002

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-060-6

EC Name:

-

Cas Number:

24065-33-6

Molecular formula:

Hill formula: C5H3ClO2S CAS formula: C5H3ClO2S

IUPAC Name:

5-chlorothiophene-2-carboxylic acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Esd:NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories France, 69592 L’Arbresle, France
- Age at study initiation: young adult animals
- Weight at study initiation: 2.7 kg — 3.1 kg
- Housing: The animals were housed individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): The animals received the standard diet “SsniffK-Z” 4mm (manufacturer: Ssniff Spezialdiäten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

pulverizede test item moistened with water

Controls:

other:

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 0.5 g of the pulverized test substance moistened with Aqua p.i. (to ensure good contact with the skin) was applied to the skin of the animal under a gauze patch. The patch was placed on the dorso-lateral areas of the trunk of each animal and was held in place with non-irritating tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed skin area was carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1, 24, 48, 72 h

SCORING SYSTEM: The degree of erythema/eschar formation and oedema formation was recorded as specified by DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: #1 - #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal: #1 - #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Other effects:

- Other adverse local effects: not observed
- Other adverse systemic effects: not observed

Any other information on results incl. tables

Irritant Effects on the Skin (Exposure: 4 hours)

Animal 1, Body Weight 2.8 kg Observation (after patch removal)	1 h	24 h	48 h	72 h	day 7	day 14
Erythema (redness) and eschar formation	0	0	0	0
Oedema formation	0	0	0	0
Animal 2, Body Weight 3.1 kg
Observation (after patch removal)	1 h	24 h	48 h	72 h	day 7	day 14
Erythema (redness) and eschar formation	0	0	0	0
Oedema formation	0	0	0	0
Animal 3, Body Weight 2.7 kg
Observation (after patch removal)	1 h	24 h	48 h	72 h	day 7	day 14
Erythema (redness) and eschar formation	0	0	0	0
Oedema formation	0	0	0	0

Summary of Irritant Effects (Score)

Animal		24h	48 h	72 h	Mean scores	Response	Reversible (days)
1	Erythema (redness) and eschar formation	0	0	0	0.0	-	Na
	Oedema formation	0	0	0	0.0	-	Na
2	Erythema (redness) and eschar formation	0	0	0	0.0	-	Na
	Oedema formation	0	0	0	0.0	-	Na
3	Erythema (redness) and eschar formation	0	0	0	0.0	-	Na
	Oedema formation	0	0	0	0.0	-	na
no positive response : mean scores < 2 = -
positive response :mean scores ≥ 2 = +
na: not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The irritant / corrosive potential of 5-Chlorthiophen-2-carbonsäure was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002.
According to classification criteria 5-Chlorthiophen-2-carbonsäure is not an irritant to the skin. There were no systemic intolerance reactions.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404 (2002), young adult New Zealand White rabbits (3/treatment) were dermally exposed to 0.5 g/patch of Clorthiphen-2-carbonsäure (100 % a.i.) for 4 hours to 5 cm² of shaved dorsal skin. Animals then were observed for 72 h according to the adopted guideline due to the absence of any irritant effect. Irritation was scored as required by the test guideline.

Under the present test conditions all three animals showed no erythema or oedema after patch removal.

All three animals also showed no oedema and erythema at the examination time-points 24 and 48 hours after patch removal.

Based on these results the test item does not need to be classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to corrosivity.