2-Thiophenecarboxylic acid, 5-chloro-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February, 1987

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, 33178 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable)
- Age at study initiation: 9-13 weeks
- Weight at study initiation: males: 237-253 g; females: 202-222 g
- Housing: The animals were caged individually in polycarbonate cages on low dust wood
granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany)
- Historical data:
- Diet (e.g. ad libitum): The animals received the standard diet “Provimi Kliba 3883.0. 1 5 Maus/Ratte Haltung, Kaiseraugst Switzerland” ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 d
- Method of randomisation in assigning animals to test and control groups: The animals were assigned to their groups by randomization. The random list was based on evenly distributed chance numbers especially generated for the study by a software application.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±5
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 30.0 cm²
- % coverage: 10%
- Type of wrap if used: wet gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a
,,Cutiplast® steril“ coated with air-tight ,,Leukoflex®“. The gauze strip was placed on the rat’s back and secured in place using ,,Peha®-Haft“ cohesive stretch tape and additionally covered with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area was rinsed with tepid water using soap and gently patting the area dry.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 15.8 - 16.9 mg/cm² (male) 13.5 - 14.8 mg/cm² (female)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: at least once daily, weighing weekly
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight

Statistics:

An assessment ofthe LD50 was made based on the applied dose and dose-response curve, respectively.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the present investigations, 5-Chlorthiophen-2-carbonsäure is to be regarded to have the following LD50 values:
LD50 rat, male : > 2000 mg/kg body weight
rat, female : > 2000 mg/kg body weight
So it is regarded as non-toxic after dermal application.

Executive summary:

In an acute dermal toxicity study according to OECD test guideline 402 (1987), one young adult male and female Wistar rats (1/sex) were dermally exposed to 5-Chlorthiophen-2-carbonsäure (100 % a.i) for 24 hours to 10 % of body surface area at a doses of 2000 mg/kg bw.  Animals then were observed for 14 days.

Dermal LD50 Males/Females => 2000 mg/kg bw

5-Chlorthiophen-2-carbonsäure is of low Toxicity based on the LD50 value for male and female Wistar rats. Each animal of the high dose groups (2000 mg/kg bw) survived 14 days.

 Based on the results the substance does not need to be classified according to Regulation (EU) 1272/2008 (CLP) and the Globally Harmonized System for Calssification and Labelling of Chemicals (GHS) as acute toxic via the dermal route.