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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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.