α,α,α-trifluoro-4-nitro-m-cresol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-03-15 to 1994-04-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1992-07-31

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992-07-17

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trifluoro-4-nitro-m-cresol

EC Number:

201-818-2

EC Name:

α,α,α-trifluoro-4-nitro-m-cresol

Cas Number:

88-30-2

Molecular formula:

C7H4F3NO3

IUPAC Name:

α,α,α-trifluoro-4-nitro-m-cresol

impurity 1

Reference substance name:

5-chloro-α,α,α-trifluoro-2-nitrotoluene

EC Number:

204-280-7

EC Name:

5-chloro-α,α,α-trifluoro-2-nitrotoluene

Cas Number:

118-83-2

Molecular formula:

C7H3ClF3NO2

IUPAC Name:

4-Chloro-1-nitro-2-(trifluoromethyl)benzene

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

impurity 3

Reference substance name:

3-Carboxy-4-nitrophenol

Cas Number:

610-37-7

Molecular formula:

C7H5NO5

IUPAC Name:

3-Carboxy-4-nitrophenol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: C02910506
- Expiration date of the batch: 1995-02

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in darkness, under fume cupboard

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb: NZW (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemical pharmaceutical factory, 88400 Biberach
- Age at study initiation: ~3 - 5 month
- Weight at study initiation: 2.3 - 2.7 kg
- Housing: individually
- Diet: ad libitum, Altromin 2123 maintenance diet - rabbits, Altromin GmbH, Lage/Lippe, Germany and hay (~15 g daily).
- Water: ad libitum
- Acclimation period: 7 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

21 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal region
- coverage: 2.5 cm x 2.5 cm
- Type of wrap: cellulose patch, surgical plaster, semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing : warm tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
30 - 60 min, 24 h, 48 h, 72 h, day 7, day 14, and day 21

SCORING SYSTEM:
- Method of calculation: according to the technique of Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

fully reversible within 21 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

fully reversible within 21 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks:

fully reversible within 21 d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Any other information on results incl. tables

Sex: Female	Erythema (time after decontamination)
Animal No.	30 – 60 min	1 day	2 days	3 days	7 days	14 days	21 days	Mean Score
56	3	2	3	3	2	3	0	2.7
57	3	3	3	3	2	1	0	3.0
58	3	3	3	4	2	2	0	3.3
							Overall Mean	3.0

 

Sex: Female	Oedema (time after decontamination)
Animal No.	30 – 60 min	1 day	2 days	3 days	7 days	14 days	21 days	Mean Score
56	4	3	3	3	2	0	0	3.0
57	3	2	2	2	1	0	0	2.0
58	4	3	3	3	2	0	0	3.0
							Overall Mean	2.7

 

The means have been calculated using the day 1, 2, and 3 values

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

In an in vivo study acording to EU Method B.4, the test substance showed skin corroding effects in rabbits.

Executive summary:

In a primary dermal irritation study according to EU Method B.4, a group (3♀) of 3 - 5 month old New Zealand White rabbits were dermally exposed to 0.5 mL of the test substance for 4 hours to 6.25 cm² skin (Hoechst AG, 1994). Animals then were observed for 21 days. Irritation was scored according to Draize et al. (1959). Erythrema was observed in all animals (individual mean score 24/48/72 h: animal #1 2.67, animal #2 3.0, animal #3 3.3), being completely reversible within 21 days. Edema was observed in all animals (individual mean score 24/48/72 h: animal #1 3.0, animal #2 2.0, animal #3 3.0), completely reversible within 14 days.

4-nitro-3-(trifluoromethyl)phenol was corrosive to the skin based on the individual mean score (24/48/72 h).