1-(3,5-Dichloro-4-fluoro-phenyl)-2,2,2-trifluoro-ethanone

Endpoint summary

Description of key information

Skin irritation / corrosion:

In vivo skin irritation, key study:

The study was performed to assess the irritancy potential of the test item following a single, 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.

The test item was classified as corrosive to rabbit skin (based on one animal).

Eye irritation:

The study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1).

 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2014-04-09 to 2014-05-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: CPFOA1301
Purity: 98.5%

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.74 kg
- Housing: individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

Immediately following patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: the trunk of the rabbit was wrapped in an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours after application

OBSERVATION TIME POINTS
Immediately following removal of the patches

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Score: 4, immediately following patch removal

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Score 3, immediately following patch removal

Irritant / corrosive response data:

Grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema were noted in the treated skin site immediately after patch removal. The reactions were indicative of dermal corrosion.
The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction, therefore, the animal was humanely killed immediately after the observation.

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

The test item was classified as corrosive to rabbit skin (based on one animal).

Executive summary:

The study was performed to assess the irritancy potential of the test item following a single, 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.

A single 4-Hour, semi occluded application of the test item to the intact skin of one rabbit produced grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema. The reactions were indicative of dermal corrosion.

The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction, therefore, the animal was humanely killed immediately after the observation.

The test item was classified as corrosive to rabbit skin (based on one animal).

 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion:

In vivo skin irritation, key study, OECD 404:

A single 4-Hour, semi occluded application of the test item to the intact skin of one rabbit produced grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema. The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction.

According to Regulation (EC) No 1272/2008, table 3.2.1, this substance should be classified as Skin corrosion category 1.

 

Eye irritation:

As the substance is classified as skin corrosion, according to Regulation (EC) No 1272/2008, section 3.3.2.2.2., this substance should be classified as serious eye damage (Category 1).