2-Thiophenecarboxylic acid, 5-chloro-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-11-03 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

HsdIf:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan France, 03800 Gannat, France)
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.3 kg — 2.5 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 Spezialdiieiten 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

Vehicle:

unchanged (no vehicle)

Controls:

other:

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

SCORING SYSTEM: According to DRAIZE

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

iris score

Basis:

animal: #1 - #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

There was corneal opacity in one animal with a score of 1.7 which was not reversible during the 21 experimental days, thus, the test item is considered corrosive to the eyes.

Any other information on results incl. tables

Animal		24 h	48 h	72 h	Mean scores	Response	Reversible (days)
1	Corneal opacity	0	2	3	1.7	-	Not revers.
	Iritis	0	0	0	0.0	-	na
	Redness conjunctivae	2	2	2	2.0	-	14
	Chemosis conjunctivae	2	2	1	1.7	-	7
2	Corneal opacity	0	2	2	1.3	-	7
	Iritis	0	0	0	0.0	-	na
	Redness conjunctivae	2	2	2	2.0	-	14
	Chemosis conjunctivae	1	1	0	0.7	-	3
3	Corneal opacity	0	2	2	1.3	-	14
	Iritis	0	0	0	0.0	-	na
	Redness conjunctivae	2	3	2	2.3	-	14
	Chemosis conjunctivae	1	1	1	1.0	-	7
response: corneal opacity : mean scores < 2 = - , ≥ 2 < 3 = +; ≥ 3 = ++ iritis : mean scores < 1 = - , ≥ 1 < 2 = +; = 2 = ++ conjunctival redness : mean scores < 2.5 = - , ≥2.5 = + conjunctival oedema : mean scores < 2 = - ; ≥ 2 = + na : not applicable

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

According to classification criteria 5-Chlorthiophen-2-carbonsäure causes serious damage to eyes without reversibility within 21 days in one animal. There were no systemic intolerance reactions.

Executive summary:

In a primary eye irritation study according to OECD test guideline 405 (2002), 0.1 g 5-Chlorthiophen-2-carbonsäure (100 % a.i.) were instilled into the conjunctival sac of one eye of 3 young adult New Zealand White rabbits for 24 hours. After 24 hours the eye was gently washed with physiological saline. Animals then were observed for 21 days. Irritation was scored by the method of Draize.

After application of 0.1 g of the test sample into the conjunctival sac, there were moderate reactions in the cornea that were not reversible in one animals within 21 days and initially stronger changes in the conjunctivae, which are completely reversible within 14 days. According to Regulation (EU) No. 1272/2008 (CLP) the test item is classified as Category 1 (irriversible effects to the to eye) based on the results obtained under the conditions described.