4-chloro-α,α,α-trifluoro-3-nitrotoluene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - July 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: in accordance with guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-α,α,α-trifluoro-3-nitrotoluene

EC Number:

204-451-6

EC Name:

4-chloro-α,α,α-trifluoro-3-nitrotoluene

Cas Number:

121-17-5

Molecular formula:

C7H3ClF3NO2

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): MN
- Physical state: yellow liquid
- Lot/batch No.: RV7
- Expiration date of the lot/batch: November 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature (avoid contact with strong bases and oxidizing agents)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Conelli s.n.c. - Arona (NO)- Italy
- Age on receipt: 2-3 months
- Weight on receipt: 2-3 kg
- Housing:individual caging in T06C air conditioned room, metal cages measuring 62 x 47.5 x 38 (h) cm, with stainless feeder. The cages were hung on metal racks over a stainless waste system.
- Diet : ad libitum (GLP 2RB 15 certificate pelleted diet produced by Charles River Italia's feed licensee mucedola s.r.l. (Settimo Milanese). the diet was supplemented by the Producer with vitamins and trace elements.
- Water : ad libitum from the municipal water main system (periodically analyzed and filtered)
- Acclimation period: about 2 months.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50 ± 15%
- Air changes (per hr): about 15/hour
- Photoperiod (hrs dark / hrs light): artifical light with a circadian cycle of 12 hours of light.

IN-LIFE DATES: From: June 7, 1994 To: June 10, 1994

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent areas of untreated skin of each animal served as control for the test.

Amount / concentration applied:

0.5 mL /animal

Duration of treatment / exposure:

3 minutes, 1 and 4 hours

Observation period:

immediately after the 3 minutes and the 1 -hour exposure period and at 72 hours and day 8 in the first rabbit nd at 1, 24, 48, 72 hours and 8 days after the 4-hour exposure period (all rabbits).

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: trunk
- % coverage: approximately 6 cm2 of skin
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape.


STEPS
- 1: one rabbit was used and 3 treatment sites of the skin were prepared. On the first, the test article was applied for 3 minutes. Since no serious gross skin reaction was noted, the test article was applied for 1 hour on the second site. Since no serious gross skin reaction was observed also afterthis period, the test article was applied for an exposure period of 4 hours on the third skin site.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 3 minutes, 1 and 4 hours.

SCORING SYSTEM:
The skin reaction was scored according to the following scale:

ERYTHEMA and ESCHAR FORMATION
no erythema: 0
very slight erythema (barely perceptible): 1
well-defined erythema: 2
moderate to severe erythema: 3
severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

EDEMA FORMATION
no edema: 0
very slight edema (barely perceptible): 1
slight edema (edges of area well defined by definite raising): 2
moderate edema (raised approx 1 mm): 3
severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

1

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

1

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

0

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

0

Results 9

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Results 10

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article MN, when administered by dermal route to rabbits under the experimental conditions adopted, has to be considered NON IRRITANT for the skin.

Executive summary:

An acute dermal irritation study, with a single administration of 0.5 mL of the test article MN in the New Zealand White rabbit (3 animals) was performed. No untoward clinical sign or behavioral alteration was observed. At the application site, slight transient signs of dermal irritancy were observed in all treated rabbits. No sign was evident at the 72 -hours observation in any animal.