α,α,α,4-tetrachlorotoluene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

June 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

α,α,α,4-tetrachlorotoluene

EC Number:

226-009-1

EC Name:

α,α,α,4-tetrachlorotoluene

Cas Number:

5216-25-1

Molecular formula:

C7H4Cl4

IUPAC Name:

1-chloro-4-(trichloromethyl)benzene

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)
- Age on receipt: 2-3 months
- Weight on receipt: 2-3 kg
- Housing:individual cages in T06C air-conditioned room. metal cages meauring 62 x 47.5 x 38 (h) cm with stainless feeder, hung on metal racks.
- Diet: ad libitum GLP 2 RB 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 libitumfrom the municipal water main system
- Acclimation period: about 2 months.

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

IN-LIFE DATES: From: June 7, 1994 To: June 21, 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:

immediatley after the 3 minute and the 1 hour-exposure period and at 72 hours and day 8 in the first rabbit and 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 6cm2 of the skin
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non irritant, hypoallergenic tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 3 minutes, 1 hour, 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:

animal: 94M

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

not fully reversible within: 15 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 98M and 100M

Time point:

24/48/72 h

Score:

1.66

Max. score:

2

Reversibility:

not fully reversible within: 15 days

Results 3

Irritation parameter:

edema score

Basis:

animal: 94M, 98M and 100M

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 15 days

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant) based on CLP criteria

Conclusions:

Skin irritant

Executive summary:

Experimental data obtained from the dermal irritation study after a single administration of 0.5 mL of the test article PCBTC in the New Zealand White rabbit (3 animals) show that no untoward clinical signs or behavioral alterations were observed. Signs of dermal irritancy were observed in all treated rabbits. The test article PCBTC, when administered by dermal route to rabbits under the experimental conditions adopted, has to be considered IRRITANT for the skin.